| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO 22675:2016 |
Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods |
IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to this International Standard.
WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, ISO 22675:2016 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
|
Published |
2016-06 |
Edition : 2 |
Number of pages : 91 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/FDIS 22675 |
Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods |
|
Under development |
|
Edition : 3 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 22676:2006 |
Prosthetics — Testing of ankle-foot devices and foot units — Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment |
ISO/TR 22676:2006 offers guidance on:
the specification of the test loading conditions of ISO 22675;the design of appropriate test equipment.
Most of the text of ISO/TR 22676:2006 relates to the theoretical and technical background and the design of the equipment.
|
Published |
2006-10 |
Edition : 1 |
Number of pages : 62 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23500:2014 |
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice.
ISO 23500:2014 addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.
|
Withdrawn |
2014-04 |
Edition : 2 |
Number of pages : 85 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 22679:2021 |
Cardiovascular implants — Transcatheter cardiac occluders |
This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system.
Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders.
This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders.
The following devices and components are outside the scope of this document: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components.
This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling.
This document defines operational conditions and performance requirements for cardiac occluders where either adequate scientific or clinical evidence, or both, exists for their justification.
NOTE At the time of this document, it is impossible to take all future and emerging technologies into consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in order to verify and validate these cardiac occluder systems.
|
Published |
2021-11 |
Edition : 1 |
Number of pages : 72 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/PRF 22926 |
Implants for surgery — Specification and verification of synthetic anatomical bone models for testing |
|
Under development |
|
Edition : 1 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23089-2:2021 |
Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices |
This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures.
This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.
|
Published |
2021-05 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23317:2007 |
Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials |
ISO 23317:2007 describes the method for detecting apatite formed on a surface of a material in simulated body fluid (SBF).
|
Withdrawn |
2007-06 |
Edition : 1 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23317:2012 |
Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials |
ISO 23317:2012 specifies a method for detecting apatite formed on a surface of a material in simulated body fluid (SBF). It is applicable to implant surfaces intended to come into direct bone contact.
|
Withdrawn |
2012-10 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23317:2014 |
Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials |
ISO 23317:2014 specifies a method for detecting apatite formed on a surface of a material in simulated body fluid (SBF). It is applicable to implant surfaces intended to come into direct bone contact.
|
Published |
2014-06 |
Edition : 3 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 23317 |
Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials |
|
Under development |
|
Edition : 4 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23500-1:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements |
1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
1.2 Inclusions This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.
For the purposes of this document, dialysis fluid includes:
a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,
b) dialysis water used for the preparation of concentrates at the user's facility,
c) concentrates,
d) the final dialysis fluid and substitution fluid.
The scope of this document includes
a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
1.3 Exclusions This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.
|
Published |
2019-02 |
Edition : 1 |
Number of pages : 87 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 23810:2006 |
Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup |
ISO/TS 23810:2006 covers activities performed by perfusionists during equipment setup prior to cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left or right heart bypass (LHB, RHB) and venovenous (VV) extracorporeal support for liver transplantation.
|
Withdrawn |
2006-07 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 23500-1 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements |
1.1 General
This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
1.2 Inclusions
This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.
For the purposes of this document, dialysis fluid includes:
a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,
b) dialysis water used for the preparation of concentrates at the user's facility,
c) concentrates,
d) the final dialysis fluid and substitution fluid.
The scope of this document includes
a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
1.3 Exclusions
This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.
|
Under development |
|
Edition : 2 |
Number of pages : 105 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies |
1.1 General This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2 Inclusions This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c) the reprocessing of dialysers intended for single use where permitted for multiple uses,
d) the reprocessing of dialysers not specifically marked as intended for single use.
This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
1.3 Exclusions This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.
|
Published |
2019-02 |
Edition : 1 |
Number of pages : 34 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 23500-2 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies |
1.1 General
This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2 Inclusions
This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c) the reprocessing of dialysers intended for single use where permitted for multiple uses,
d) the reprocessing of dialysers not specifically marked as intended for single use.
This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
1.3 Exclusions
This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.
|
Under development |
|
Edition : 2 |
Number of pages : 35 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies |
This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
|
Published |
2019-02 |
Edition : 1 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 23500-3 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies |
This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
|
Under development |
|
Edition : 2 |
Number of pages : 20 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8458-3:1992 |
Steel wire for mechanical springs — Part 3: Oil-hardened and tempered wire |
Specifies requirements and test methods (surface condition, chemical composition, tensile strength, ductility, surface quality) for wires intended for static duty and dynamic duty applications. Wire diameters range from 0,50 mm to 15,00 mm.
|
Withdrawn |
1992-11 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies |
This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
|
Published |
2019-02 |
Edition : 1 |
Number of pages : 22 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 23500-4 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies |
This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
|
Under development |
|
Edition : 2 |
Number of pages : 22 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
|
Published |
2019-02 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 23500-5 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
|
Under development |
|
Edition : 2 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 23500:2011 |
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
ISO 23500:2011 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2011 functions as a recommended practice.
ISO 23500:2011 addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2011, the dialysis fluid includes water used for the preparation of dialysis fluid and substitution fluid, water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.
Excluded from the scope of ISO 23500:2011 are sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis.
|
Withdrawn |
2011-05 |
Edition : 1 |
Number of pages : 82 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8458-3:2002 |
Steel wire for mechanical springs — Part 3: Oil-hardened and tempered wire |
ISO 8458-3 specifies requirements for oil-hardened and tempered carbon and low alloy steel wire, for the manufacture of mechanical springs for static duty and dynamic duty applications, complying with the general requirements of ISO 8458-1.
|
Published |
2002-10 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
77.140.25
Spring steels
|
| ISO/TS 23810:2012 |
Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup |
ISO/TS 23810:2012 covers the activities performed by perfusionists during preoperative extracorporeal circulation (ECC) equipment setup prior to cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left or right heart bypass (LHB/RHB) or venovenous (VV) extracorporeal support for liver transplantation. Its requirements can serve as a checklist for verifying that the equipment, devices or systems have been set up correctly.
|
Withdrawn |
2012-04 |
Edition : 2 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 23810:2018 |
Cardiovascular implants and artificial organs — Checklists for use of extracorporeal circulation equipment |
This document covers the activities performed by perfusionists before, during, and after extracorporeal circulation.
Clause 4 covers the perfusionists' actions during preoperative extracorporeal circulation (ECC) equipment setup prior to cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left or right heart bypass (LHB/RHB) or venovenous (VV) extracorporeal support for liver transplantation. Its requirements can serve as a checklist for verifying that the equipment, devices or systems have been set up correctly. The sequence of use of checklist items listed below can vary depending on customary institutional use or individual user preference. There are also four additional checklists for different phases of ECC (see Clause 5, Termination; Clause 6, Post-extracorporeal circulation; Clause 7, Emergent reinstitution of extracorporeal circulation; and Clause 8, Peri-procedural).
|
Published |
2018-07 |
Edition : 3 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 24085-1 |
Implants for Surgery — Partial and total shoulder joint prosthesis — Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres |
|
Deleted |
|
Edition : 1 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 24085-2 |
Implants for Surgery — Partial and total shoulder joint prosthesis — Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses |
|
Deleted |
|
Edition : 1 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 24560-1:2022 |
Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping |
This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping MRI in humans with a typical example of the methods; each are distinct MRI technologies that allow for noninvasive observation of soft tissue characteristics.
The methods provided in this document are intended for application in the evaluation of the clinical effects of tissue-engineered cartilage or other cartilage regeneration products used in the knee joint, and are also applicable for the evaluation of regenerative cartilage in other joints, although some modification of parameters is needed.
This document describes a longitudinal evaluation of the water content, the glycosaminoglycan (GAG) concentration, and the concentration and orientation of collagen fibres in regenerative cartilage when using dGEMRIC and T2-mapping techniques in 1,5 T or 3,0 T magnetic resonance imaging equipment.
|
Published |
2022-07 |
Edition : 1 |
Number of pages : 31 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 24562:2022 |
Prosthetics — Geometrical aspects of lower limb prosthetic adapters |
This document specifies dimensions of the adult modular systems adapters used in lower limb prosthetic.
|
Published |
2022-01 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 25539-1:2003 |
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
ISO 25539-1:2003 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
ISO 25539-1:2003 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.
ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
|
Withdrawn |
2003-03 |
Edition : 1 |
Number of pages : 42 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 25539-1:2003/Amd 1:2005 |
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses — Amendment 1: Test methods |
|
Withdrawn |
2005-07 |
Edition : 1 |
Number of pages : 45 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 1122-2:1999 |
Vocabulary of gear terms — Part 2: Definitions related to worm gear geometry |
|
Published |
1999-08 |
Edition : 1 |
Number of pages : 20 |
Technical Committee |
21.200
Gears
;
01.040.21
Mechanical systems and components for general use (Vocabularies)
|
| ISO 25539-1:2017 |
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
ISO 25539-1:2017 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices.
ISO 25539-1:2017 is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.
Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555‑4, specific to the use of balloons with endovascular prostheses.
ISO 25539-1:2017 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.
NOTE 1 Cardiac valved conduits are within the scope of ISO 5840‑1.
Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417.
ISO 25539-1:2017 does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of endovascular prostheses.
The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.
NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.
|
Published |
2017-02 |
Edition : 2 |
Number of pages : 122 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 25539-2:2008 |
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
ISO 25539-2:2008 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The scope of ISO 25539-2:2008 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1:2003. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1:2003 and ISO 25539-2:2008.
Delivery systems are included in ISO 25539-2:2008 if they comprise an integral component of the deployment of the vascular stent.
Some pharmacological aspects of drug eluting stents are addressed in ISO 25539-2:2008, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.
With the exception of sterilization, ISO 25539-2:2008 does not address requirements for the evaluation of animal tissue products.
|
Withdrawn |
2008-09 |
Edition : 1 |
Number of pages : 93 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 25539-2:2012 |
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
|
Withdrawn |
2012-12 |
Edition : 2 |
Number of pages : 92 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 25539-2:2020 |
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1.
Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices.
NOTE 3 Absorbable implants are within the scope of ISO/TS 17137.
Although coated stents and coated stent systems are within the scope of this document, this document is not comprehensive with respect to coatings.
NOTE 4 Some coating properties are within the scope of ISO 17327-1.
This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.
|
Published |
2020-09 |
Edition : 3 |
Number of pages : 114 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 25539-3:2011 |
Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The following are within the scope of ISO 25539-3:2011:
vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites;
sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter.
delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter.
optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.
The following are outside the scope of ISO 25539-3:2011:
temporary filters (e.g. tethered) that need to be removed after a defined period of time;
coatings, surface modifications, and/or drugs;
issues associated with viable tissues and non-viable biological materials;
degradation and other time-dependent aspects of absorbable materials;
procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.
|
Published |
2011-12 |
Edition : 1 |
Number of pages : 93 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 25539-3 |
Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
|
Under development |
|
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 29783-3:2016 |
Prosthetics and orthotics — Vocabulary — Part 3: Pathological gait (excluding prosthetic gait) |
ISO 29783-3:2016 specifies a method of describing abnormal gait patterns resulting from pathology (excluding prosthetic gait) by identifying the deviations from the normal pattern of gait during each sub-phase of the gait cycle. The description of the deviations includes references to abnormal foot contact and abnormalities of joint motion.
|
Published |
2016-06 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/R 1122:1969 |
Withdrawal of ISO/R 1122-1969 |
|
Withdrawn |
1969-10 |
Edition : 1 |
Number of pages : 30 |
Technical Committee |
21.200
Gears
;
01.040.21
Mechanical systems and components for general use (Vocabularies)
|
| ISO 25539-4:2021 |
Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices |
This document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137.
The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO2, and non-oxide, such as amorphous silicon carbide and diamond-like carbon).
This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings.
This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document.
This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.
|
Published |
2021-11 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 26722:2009 |
Water treatment equipment for haemodialysis applications and related therapies |
ISO 26722:2009 is addressed to the manufacturer and/or provider of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
ISO 26722:2009 covers devices used to treat water intended for use in the delivery of haemodialysis and related therapies. Included in the scope of this International Standard is water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid that may be used for the preparation of substitution fluid; (3) the reprocessing of dialysers for multiple uses.
Included within the scope of ISO 26722:2009 are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system and the point of use of the dialysis water. Examples of devices included within the scope of this International Standard are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
|
Withdrawn |
2009-04 |
Edition : 1 |
Number of pages : 30 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 26722:2014 |
Water treatment equipment for haemodialysis applications and related therapies |
ISO 26722:2014 is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
ISO 26722:2014 covers devices used to treat water intended for use in the delivery of haemodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; (3) the reprocessing of dialysers for multiple uses.
Included within the scope of ISO 26722:2014 are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of devices included within the scope of ISO 26722:2014 are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
|
Withdrawn |
2014-04 |
Edition : 2 |
Number of pages : 34 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 27185:2012 |
Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols that comply with the requirements of ISO 27185:2011.
ISO 27185:2011 is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling.
|
Published |
2012-02 |
Edition : 1 |
Number of pages : 31 |
Technical Committee |
01.080.20
Graphical symbols for use on specific equipment
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 27185 |
Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
|
Under development |
|
Edition : 2 |
|
Technical Committee |
01.080.20
Graphical symbols for use on specific equipment
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 27186:2010 |
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
ISO 27186:2010 specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.
|
Withdrawn |
2010-03 |
Edition : 1 |
Number of pages : 81 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6336-3:2006 |
Calculation of load capacity of spur and helical gears — Part 3: Calculation of tooth bending strength |
ISO 6336-3:2006 specifies the fundamental formulae for use in tooth bending stress calculations for involute external or internal spur and helical gears.
|
Withdrawn |
2006-09 |
Edition : 2 |
Number of pages : 42 |
Technical Committee |
21.200
Gears
|
| ISO 27186:2020 |
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements |
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.
NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.
This document does not specify all connector features.
This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
|
Published |
2020-11 |
Edition : 2 |
Number of pages : 81 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 27186 |
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements |
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.
NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.
This document does not specify all connector features.
This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
|
Under development |
|
Edition : 3 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 29781:2008 |
Prostheses and orthoses — Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth |
ISO 29781:2008 describes the factors to be included when describing the physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth.
|
Published |
2008-12 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 29782:2008 |
Prostheses and orthoses — Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation |
ISO 29782:2008 describes the factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.
|
Withdrawn |
2008-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 29782:2022 |
Prostheses and orthoses — Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation |
This document lists factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.
|
Published |
2022-12 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 29783-1:2008 |
Prosthetics and orthotics — Vocabulary — Part 1: Normal gait |
ISO 29783-1:2008 establishes a vocabulary for the description of normal gait.
|
Published |
2008-12 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 29783-2:2015 |
Prosthetics and orthotics — Vocabulary — Part 2: Prosthetic gait |
ISO 27983-2:2015 specifies a vocabulary for the description of prosthetic gait.
|
Published |
2015-02 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 37137-1:2021 |
Biological evaluation of absorbable medical devices — Part 1: General requirements |
This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).
|
Published |
2021-03 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 37137:2014 |
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
The objective of ISO/TR 37137:2014 is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.
|
Published |
2014-05 |
Edition : 1 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| IEC/TR 62653:2012 |
Guidelines for the safe use of medical products in dialysis treatment |
IEC/TR 62653:2012(E) which is a technical report, describes the technical requirements for use of equipment in haemodialysis, haemofiltration and haemodiafiltration. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the haemodialysis treatment prescription. However, the organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. If applicable, the scope may be applicable to the use of the equipment in paediatrics, home haemodialysis, acute and sorbent dialysis systems. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
|
Withdrawn |
2012-06 |
Edition : 1 |
Number of pages : 25 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 4708:1985 |
Cork — Composition cork gasket material — Test methods |
|
Withdrawn |
1985-07 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 4708:2000 |
Composition cork — Gasket material — Test methods |
|
Withdrawn |
2000-03 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 4708:2015 |
Composition cork — Gasket material — Test methods |
ISO 4708:2015 spécifie les méthodes d'essai pour déterminer les caractéristiques de l'aggloméré composé de liège et du liège et caoutchouc destinés à la fabrication de joints pour industries mécaniques. Les caractéristiques suivantes sont prises en considération:
- épaisseur,
- masse volumique apparente,
- résistance à la traction,
- compressibilité et récupération,
- flexibilité,
- résistance à l'eau bouillante,
- comportement dans les fluides.
|
Withdrawn |
2015-09 |
Edition : 3 |
Number of pages : 8 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 4708:2017 |
Composition cork — Gasket material — Test methods |
ISO 4708:2017 specifies test methods to determine the characteristics of agglomerated composition cork and rubbercork to be used as gaskets in the mechanical industry. The following characteristics are considered:
- thickness,
- apparent density,
- tensile strength,
- compressibility and recovery,
- flexibility,
- resistance to boiling water,
- behaviour in fluids.
|
Published |
2017-09 |
Edition : 4 |
Number of pages : 8 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 4709:1985 |
Cork — Composition cork gasket material — Specifications |
|
Withdrawn |
1985-05 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 4709:2000 |
Composition cork — Gasket material — Classification system, requirements, sampling, packaging and marking |
|
Withdrawn |
2000-12 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 4709:2017 |
Composition cork — Gasket material — Classification system, requirements, sampling, packaging and marking |
ISO 4709 gives a classification system for composition cork intended to be used as gaskets in the mechanical industry. It provides a means for specifying or describing the relevant properties.
Since not all properties that contribute to gasket performance are included, the use of this system is limited to the selection of materials in accordance with specified requirements.
|
Published |
2017-10 |
Edition : 3 |
Number of pages : 7 |
Technical Committee |
21.140
Seals, glands
;
79.100
Cork and cork products
|
| ISO 9442:1988 |
Steel — Hot-rolled ribbed and grooved flats for spring leaves — Tolerances and dimensions |
Applies to hot-rolled spring steel with the dimensions stated in table 1, of the steel grades listed in clause 4, which are preferably used for rail vehicle construction. Specifies dimensions and tolerances, material, mode of delivery and testing.
|
Published |
1988-10 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 9222-1:1989 |
Technical drawings — Seals for dynamic application — Part 1: General simplified representation |
This method indicates only essential features ans should be used when it is not necessary to show the exact shape and details of the seals, for example in assembly drawings. The degree of simplification depends on the kind of object represented, the scale of the drawing and the purpose of documentation. ISO 9222-2 deals with the detailed simplified representation.
|
Published |
1989-06 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
21.140
Seals, glands
;
01.100.20
Mechanical engineering drawings
|
| ISO 9222-2:1989 |
Technical drawings — Seals for dynamic application — Part 2: Detailed simplified representation |
In contrast to the general simplified representation of part 1, this method shows more details of a seal, for example the configuration of lips. It should also be used when it is not necessary to show the exact shape and details of the seals, for example in assembly drawings. Elements and examples of this representation mode are given in tables and figures.
|
Published |
1989-07 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
21.140
Seals, glands
;
01.100.20
Mechanical engineering drawings
|
| ISO 7483:1991 |
Dimensions of gaskets for use with flanges to ISO 7005 |
Specifies dimensions for the following types of gaskets: non-metallic flat; spiral wound; metallic ring-joint; non-metallic envelope; corrugated, flat or grooved metallic and filled metallic. Annexes A and B are for information only.
|
Published |
1991-10 |
Edition : 1 |
Number of pages : 33 |
Technical Committee |
23.040.80
Seals for pipe and hose assemblies
|
| ISO 7483:1991/Cor 1:1995 |
Dimensions of gaskets for use with flanges to ISO 7005 — Technical Corrigendum 1 |
Replaces nominal size and mean pitch diameter in table 14.
|
Published |
1995-08 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
23.040.80
Seals for pipe and hose assemblies
|
| ISO 9691:1992 |
Rubber — Recommendations for the workmanship of pipe joint rings — Description and classification of imperfections |
Classifies imperfections in surface and internal imperfections and specifies maximum acceptable limits.
|
Published |
1992-11 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
23.040.80
Seals for pipe and hose assemblies
|
| ISO 2162-1:1993 |
Technical product documentation — Springs — Part 1: Simplified representation |
Gives rules for the simplified representation of compression, extension, torsion, disc, spiral and leaf springs on technical drawings.
|
Published |
1993-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
21.160
Springs
;
01.100.20
Mechanical engineering drawings
|
| ISO 2162-2:1993 |
Technical product documentation — Springs — Part 2: Presentation of data for cylindrical helical compression springs |
Establishes a uniform system for the presentation of technical data and for the representation of cylindrical helical compression springs to be used in technical product documentation intended for e.g. tender and/or order drawings.
|
Published |
1993-12 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
21.160
Springs
;
01.100.20
Mechanical engineering drawings
|
| ISO 2162-3:1993 |
Technical product documentation — Springs — Part 3: Vocabulary |
Defines 33 terms in English and French for the description of springs and their characteristics to be used in technical product documentation.
|
Withdrawn |
1993-11 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
21.160
Springs
;
01.040.01
Generalities. Terminology. Standardization. Documentation (Vocabularies)
;
01.040.21
Mechanical systems and components for general use (Vocabularies)
;
01.100.20
Mechanical engineering drawings
|
| ISO 2162:1973 |
Technical drawings — Representation of springs |
|
Withdrawn |
1973-03 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
21.160
Springs
;
01.100.20
Mechanical engineering drawings
|
| ISO 11891:2012 |
Hot formed helical compression springs — Technical specifications |
This International Standard specifies the materials, shapes, spring characteristics, tolerances, manufacturing
requirements and test methods for common helical compression springs, which are made from hot coiled
round section steel bar, and then quenched and tempered (hereinafter simply "springs").
The following limit values apply to springs conforming to this International Standard:
— free length: ≤ 900 mm;
— spring index: 3 to 12;
— slenderness ratio: 0,8 to 4;
— active coils: ≥ 3;
— spring pitch: < 0,5D;
— wire diameter: 8 mm to 60 mm;
— mean diameter of coil: ≤ 460 mm.
This International Standard is not applicable to coil springs with special performance requirements, such as
railway and automotive suspensions.
|
Published |
2012-04 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
21.160
Springs
|
| ISO 6336-3:2006/Cor 1:2008 |
Calculation of load capacity of spur and helical gears — Part 3: Calculation of tooth bending strength — Technical Corrigendum 1 |
|
Withdrawn |
2008-06 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
21.200
Gears
|
| ISO 16249:2013 |
Springs — Symbols |
ISO 16249:2013 specifies specifies general principles for the creation of symbols of physical quantities, coefficients, and parameters for metal springs. It specifies the presentation of basic characters, subscripts, and application symbols for use in the field of helical compression springs, helical extension springs, helical torsion springs, flat springs, and leaf springs with attention to technical product documentation, especially for describing and ordering.
|
Published |
2013-04 |
Edition : 1 |
Number of pages : 21 |
Technical Committee |
21.160
Springs
;
01.100.20
Mechanical engineering drawings
|
| ISO 18137:2015 |
Leaf springs — Technical specifications |
ISO 18137:2015 specifies the technical specifications for leaf springs.
ISO 18137:2015 is applicable to leaf springs for road vehicle (hereinafter simply "springs"). The leaf springs for other vehicle may refer to this International Standard.
|
Published |
2015-08 |
Edition : 1 |
Number of pages : 18 |
Technical Committee |
21.160
Springs
|
| ISO 19690-1:2017 |
Disc springs — Part 1: Calculation |
ISO 19690-1:2017 specifies design criteria and features of disc springs, whether as single disc springs or as stacks of disc springs. It includes the definition of relevant concepts, as well as design formulae, and covers the fatigue life of such springs.
|
Published |
2017-03 |
Edition : 1 |
Number of pages : 13 |
Technical Committee |
21.160
Springs
|
| ISO 19690-2:2018 |
Disc springs — Part 2: Technical specifications |
This document specifies two different grades of disc springs.
Grade A defines basic requirements of disc springs for static applications with low and moderate performance. Springs manufactured according to Grade A are not used for dynamic applications.
Grade B defines requirements on disc springs especially used for dynamic applications and high performance static applications. Disc springs according to Grade B ensure a better quality by higher demands on manufacturing processes and tolerance requirements. Grade B includes graphs showing the guaranteed fatigue life such as a function of stress.
|
Published |
2018-09 |
Edition : 1 |
Number of pages : 29 |
Technical Committee |
21.160
Springs
|
| ISO 22705-1:2021 |
Springs — Measurement and test parameters — Part 1: Cold formed cylindrical helical compression springs |
This document specifies the measurement and test methods for the general characteristics of cold formed helical compression springs made from round wire, excluding dynamic testing.
|
Published |
2021-03 |
Edition : 1 |
Number of pages : 30 |
Technical Committee |
21.160
Springs
|
| ISO 22705-2:2023 |
Springs — Measurement and test parameters — Part 2: Cold formed cylindrical helical extension springs |
This document specifies the measurement and test methods for general characteristics of cold formed helical extension springs made from round wire, excluding dynamic testing.
|
Published |
2023-02 |
Edition : 1 |
Number of pages : 38 |
Technical Committee |
21.160
Springs
|
| ISO/DIS 22705-3 |
Springs — Measurement and test parameters — Part 3: Cold formed cylindrical helical torsion springs |
This document specifies the characteristics of cold formed cylindrical helical torsion springs made from round wire and their corresponding measurement and test methods.
|
Under development |
|
Edition : 1 |
Number of pages : 30 |
Technical Committee |
21.160
Springs
|
| ISO 26909:2009 |
Springs — Vocabulary |
ISO 26909:2009 specifies terms and definitions commonly used in the metal springs industry. Specifically, these terms appear in technical product documentation. Heat-treatment and surface-treatment terms pertinent to springs are included.
Terms in ISO 26909:2009 are grouped into the following seven categories:
a) general features of springs;
b) application of springs in machinery and engineering;
c) layouts and nomenclature of springs;
d) specification requirements;
e) design and calculation;
f) manufacturing and processing;
g) testing and inspection.
|
Published |
2009-07 |
Edition : 1 |
Number of pages : 85 |
Technical Committee |
21.160
Springs
;
01.040.21
Mechanical systems and components for general use (Vocabularies)
|
| ISO 26910-1:2009 |
Springs — Shot peening — Part 1: General procedures |
ISO 26910-1:2009 specifies general requirements for the shot peening process applied to springs in order to improve their resistance to fatigue and stress corrosion cracking, mainly by introducing compressive residual stresses into their surface layers.
|
Published |
2009-06 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
21.160
Springs
|
| ISO 26910-1:2009/Amd 1:2017 |
Springs — Shot peening — Part 1: General procedures — Amendment 1 |
|
Published |
2017-06 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
21.160
Springs
|
| ISO/FDIS 683-6 |
Heat-treatable steels, alloy steels and free-cutting steels — Part 6: Hot-rolled steels for quenched and tempered springs |
ISO 683-6 gives the technical delivery requirements for round and flat bars and wire rods manufactured from alloyed steels intended for hot-formed and subsequently heat-treated springs or cold-formed and subsequently heat-treated springs.
|
Under development |
|
Edition : 4 |
|
Technical Committee |
77.140.10
Heat-treatable steels
;
77.140.20
Stainless steels
;
77.140.25
Spring steels
|
| ISO 683-14:1992 |
Heat-treatable steels, alloy steels and free-cutting steels — Part 14: Hot-rolled steels for quenched and tempered springs |
Gives requirements of delivery for round and flat bars and wire rods manufactured from certain alloyed steels intended for hot-formed and subsequently heat-treated springs or cold formed and subsequently heat-treated springs. In addition, the general technical delivery requirements of ISO 404 are applicable. Annex A gives supplementary or special requirements, Annex B the maximum dimensions for flats and rounds.
|
Withdrawn |
1992-08 |
Edition : 2 |
Number of pages : 20 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 683-14:2004 |
Heat-treatable steels, alloy steels and free-cutting steels — Part 14: Hot-rolled steels for quenched and tempered springs |
ISO 683-14:2004 gives the technical delivery requirements for round and flat bars and wire rods manufactured from alloyed steels intended for hot-formed and subsequently heat-treated springs or cold-formed and subsequently heat-treated springs.
|
Published |
2004-02 |
Edition : 3 |
Number of pages : 22 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 6931-1:1989 |
Stainless steels for springs — Part 1: Wire |
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 6931-1:1994 |
Stainless steels for springs — Part 1: Wire |
Applies to the steel grades listed in table 1, which are generally used in the work-hardened condition in the form of wire up to about 6 mm in diameter. The produced springs are exposed to corrosive effects and sometimes slightly increased temperatures.
|
Withdrawn |
1994-06 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 6931-1:2016 |
Stainless steels for springs — Part 1: Wire |
ISO 6931-1:2016 specifies the grades of stainless steels which are generally used in the cold drawn condition in the form of wire of circular cross-section up to 10,00 mm in diameter, for the production of springs and spring parts exposed to corrosive effects and sometimes to slightly increased temperatures (see Annex A).
Certain steel grades covered by ISO 16143‑2 are also used for springs, although to a much lesser extent. In these cases, the mechanical properties (tensile strength, etc.) will be agreed between purchaser and supplier. Similarly, diameters between 10,00 mm and 15,00 mm can be ordered according to the specifications of this part of ISO 6931, in which case the parties will agree upon the required mechanical characteristics.
In addition to the specifications of this part of ISO 6931, the general technical delivery requirements of ISO 404 are applicable.
|
Published |
2016-05 |
Edition : 3 |
Number of pages : 19 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 6931-2:1989 |
Stainless steels for springs — Part 2: Strip |
Applies to the steel grades listed in table 1, which are generally used in the work-hardened condition in the form of strip up to about 1,6 mm in thickness. The produced springs are exposed to corrosive effects and sometimes slightly increased temperatures. In addition to this part of ISO 6931, the general technical delivery requirements of ISO 404 are applicable. Annex A gives additional information.
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 6931-2:2005 |
Stainless steels for springs — Part 2: Narrow strip |
ISO 6931-2:2005 applies to cold-rolled narrow strip of thicknesses up to and including 3 mm, in rolled widths less than 600 mm, made from stainless steel.
|
Published |
2005-04 |
Edition : 2 |
Number of pages : 28 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 8458-1:1989 |
Steel wire for mechanical springs — Part 1: General requirements |
Applies to uncoated steel spring wire of round cross-section, suitable for the manufacture of coiled springs. This part of ISO 8458 is not applicable to uncoated steel spring wire intended for use in upholstery springs or automotive valve springs.
|
Withdrawn |
1989-06 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 8458-1:2002 |
Steel wire for mechanical springs — Part 1: General requirements |
ISO 8458-1 specifies general requirements for steel spring wire of round cross-section, suitable for the manufacture of mechanical springs.
|
Published |
2002-08 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 8458-2:1989 |
Steel wire for mechanical springs — Part 2: Cold-drawn carbon steel wire |
Includes carbon steel wire suitable for the manufacture of loaded springs corresponding to the general requirements of ISO 8458, part 1. Applies to certain ranges of wire diameters and tensile strength grades.
|
Withdrawn |
1989-06 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
77.140.25
Spring steels
|
| ISO 8458-2:2002 |
Steel wire for mechanical springs — Part 2: Patented cold-drawn non-alloy steel wire |
ISO 8458-2 specifies requirements for cold-drawn non-alloy steel wire for the manufacture of mechanical springs for static duty and dynamic duty applications, complying with the general requirements of ISO 8458-1.
|
Published |
2002-08 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
77.140.25
Spring steels
|