| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO 10328:2006 |
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods |
ISO 10328:2005 specifies procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.
The tests described in ISO 10328:2005 comprise:
principal static and cyclic tests for all components;a separate static test in torsion for all components;separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.
The tests described in this ISO 10328:2005 apply to specific types of ankle-disarticulation prostheses, to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses.
|
Withdrawn |
2006-10 |
Edition : 1 |
Number of pages : 136 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328:2016 |
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods |
IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures 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 ISO 22675:2016.
WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.
|
Published |
2016-06 |
Edition : 2 |
Number of pages : 140 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 10328 |
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods |
|
Under development |
|
Edition : 3 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10334:1994 |
Implants for surgery — Malleable wires for use as sutures and other surgical applications |
Specifies the dimensions and mechanical properties and gives test methods. The mechanical properties specified are tensile strength, elongation, and resistance to damage in bending and in torsion. Surface finish is not covered.
|
Published |
1994-08 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 10974 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
|
Under development |
|
Edition : 1 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 10974:2012 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
ISO/TS 10974:2012 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who might undergo a magnetic resonance scan in 1,5T, cylindrical bore, whole body MR scanners for imaging the hydrogen nucleus.
The tests that are specified in ISO/TS 10974:2012 are type tests intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner.
ISO/TS 10974:2012 contains test methods that are applicable to a broad class of AIMDs for the purpose of evaluating device operation against several hazards.
|
Withdrawn |
2012-05 |
Edition : 1 |
Number of pages : 200 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12189:2008 |
Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support |
ISO 12189:2008 specifies methods for fatigue testing of spinal implant assemblies (for fusion or motion preservation) using an anterior support. It is intended to provide a basis for the assessment of intrinsic static and dynamic strength of spinal implants.
|
Published |
2008-05 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12417-1:2015 |
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
ISO 12417-1:2015 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal substance or product (drug substance, drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International Standard should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539‑series specifying requirements for endovascular devices. Requirements listed in this part of ISO 12417 also address VDDCPs that are not permanent implants.
NOTE Due to variations in the design of combination products covered by this part of ISO 12417 and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 12417 might be necessary.
Delivery systems or parts of the delivery system are included in the scope of this part of ISO 12417, if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).
Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of this part of ISO 12417 (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter).
Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of this part of ISO 12417 if they do not affect the drug-related aspects of the device.
ISO 12417-1:2015 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different national and regional authorities is given in Annex B.
Absorbable components of VDDCPs (e.g. coatings) are addressed by this part of ISO 12417 in their connection with drug-related aspects of the device. Degradation and other time-dependent aspects of absorbable implants and coatings are not completely addressed by this part of ISO 12417.
NOTE See also ISO/TS 17137 and ASTM F3036-13.
ISO 12417-1:2015 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.
ISO 12417-1:2015 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).
|
Published |
2015-10 |
Edition : 1 |
Number of pages : 49 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 10974:2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole body coil excitation.
NOTE 1 Requirements for non-implantable parts are outside the scope of this document.
The tests that are specified in this document are type tests that characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner. The tests can be used to demonstrate device operation according to its MR Conditional labelling. The tests are not intended to be used for the routine testing of manufactured products.
NOTE 2 Modification of these tests for particular device types is left to particular product committees.
NOTE 3 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific compliance criteria and determining risk.
NOTE 4 Safety requirements for MR scanners can be found in IEC 60601‑2‑33.
NOTE 5 The scope is limited to AIMDs that do not use sensing functions or to AIMDs that are programmed not to use sensing functions to affect therapy delivery during an MR scan.
|
Published |
2018-04 |
Edition : 2 |
Number of pages : 214 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11318:1993 |
Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements |
Specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators which do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements are specified along with test methods.
|
Withdrawn |
1993-12 |
Edition : 1 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11318:1993/Amd 1:1996 |
Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements — Amendment 1 |
|
Withdrawn |
1996-10 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11318:2002 |
Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements related to connector fit are specified, along with test methods.
This International Standard does not specify other connector features such as fastening means and material. This International Standard is applicable to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance, or reliability of different implantable defibrillator leads and implantable defibrillator generator assemblies.
|
Published |
2002-08 |
Edition : 2 |
Number of pages : 21 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11491:2017 |
Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip joint prostheses |
ISO 11491:2017 specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses.
|
Published |
2017-07 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11658:2012 |
Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems |
This International Standard specifies requirements for the physical, biological and performance testing of
biocompatible modifications on extracorporeal devices. This International Standard is applicable to components
of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have
modifications on the blood and tissue-contacting surfaces of the device.
The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If
hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.
|
Published |
2012-05 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11663:2009 |
Quality of dialysis fluid for haemodialysis and related therapies |
ISO 11663:2009 specifies minimum requirements for dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
ISO 11663:2009 does not address the requirements for the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation.
|
Withdrawn |
2009-04 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 11663:2014 |
Quality of dialysis fluid for haemodialysis and related therapies |
ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
|
Withdrawn |
2014-04 |
Edition : 2 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 12417-1 |
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
|
Under development |
|
Edition : 2 |
Number of pages : 49 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 12417-2:2017 |
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
ISO/TR 12417-2:2017 provides region-specific information for
- local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;
- changes related to the drug containing part and how they are evaluated by the different local regions.
For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
ISO/TR 12417-2:2017 is considered also as a supplement to ISO 12417‑1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.
|
Withdrawn |
2017-11 |
Edition : 1 |
Number of pages : 29 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 12417-2:2022 |
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
This document provides region-specific information for:
— local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;
— changes related to the drug-containing part and how they are evaluated by different local regions.
For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
This document is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. This document also addresses VDDCPs that are not necessarily permanent implants.
|
Published |
2022-07 |
Edition : 2 |
Number of pages : 29 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 12417:2011 |
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products |
ISO/TS 12417:2011 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action of the device. With regard to safety, ISO/TS 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information supplied by the manufacturer. For implanted products, ISO/TS 12417 should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ISO/TS 12417 should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in ISO/TS 12417 also address VDDCPs that are not necessarily permanent implants.
Delivery systems or parts of the delivery system are included in the scope of ISO/TS 12417 if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).
Pumps and infusion catheters which do not contain drug coverings, and whose primary mode of action is to deliver a drug, are not addressed in ISO/TS 12417.
Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 12417 if they do not affect the drug-related aspects of the device.
ISO/TS 12417 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different related national and regional authorities is given in an annex.
Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by ISO/TS 12417 in their connection with drug-related aspects of the device.
ISO/TS 12417 does not address issues associated with viable tissues and non-viable biological materials.
|
Withdrawn |
2011-06 |
Edition : 1 |
Number of pages : 48 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-1:1998 |
Retrieval and analysis of surgical implants — Part 1: Retrieval and handling |
|
Withdrawn |
1998-11 |
Edition : 1 |
Number of pages : 22 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-1:2011 |
Implants for surgery — Retrieval and analysis of surgical implants — Part 1: Retrieval and handling |
ISO 12891-1:2011 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. ISO 12891-1:2011 also provides guidance on infection control.
ISO 12891-1:2011 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.
|
Withdrawn |
2011-05 |
Edition : 2 |
Number of pages : 23 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-1:2015 |
Retrieval and analysis of surgical implants — Part 1: Retrieval and handling |
ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control.
NOTE National or other regulations, which can be more stringent, can apply.
ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.
|
Published |
2015-07 |
Edition : 3 |
Number of pages : 24 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-2:2000 |
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved metallic surgical implants |
|
Withdrawn |
2000-02 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9120:1997 |
Petroleum and related products — Determination of air-release properties of steam turbine and other oils — Impinger method |
|
Published |
1997-12 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
75.100
Lubricants, industrial oils and related products
|
| ISO 12891-2:2014 |
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants |
ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants.
ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive.
ISO 12891-2:2014 can also be applied to other materials, e.g. animal tissue implants.
ISO 12891-2:2014 can be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material.
|
Withdrawn |
2014-09 |
Edition : 2 |
Number of pages : 28 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-2:2020 |
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants |
This document specifies methods for the analysis of retrieved surgical implants.
This document describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive.
This document can also be applied to other materials, e.g. animal tissue implants.
NOTE National regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material can also apply to specific topics covered in this document.
|
Published |
2020-04 |
Edition : 3 |
Number of pages : 25 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-3:2000 |
Retrieval and analysis of surgical implants — Part 3: Analysis of retrieved polymeric surgical implants |
|
Withdrawn |
2000-02 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12891-4:2000 |
Retrieval and analysis of surgical implants — Part 4: Analysis of retrieved ceramic surgical implants |
|
Withdrawn |
2000-01 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13019:2018 |
Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis |
This document specifies test methods for the quantification of sulfated glycosaminoglycans (sGAG), one of the major extracellular matrix components in articular, meniscal, and elastic cartilages, and tissue-engineered cartilage constructs.
|
Published |
2018-06 |
Edition : 1 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13175-3:2012 |
Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
1 Scope
This part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic β-tricalcium phosphate bone substitutes and biphasic hydroxyapatite/β-tricalcium phosphate bone substitutes in the form of blocks or granules.
This part of ISO 13175 is not applicable to cell-seeded bone void fillers, calcium phosphate cements or bone void fillers containing materials other than hydroxyapatite and β-tricalcium phosphate.
|
Published |
2012-10 |
Edition : 1 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13179-1:2014 |
Implants for surgery — Plasma-sprayed unalloyed titanium coatings on metallic surgical implants — Part 1: General requirements |
ISO 13179-1:2014 specifies general requirements for plasma-sprayed unalloyed titanium coatings on metallic surgical implants. It applies to plasma spraying in air and in vacuum.
ISO 13179-1:2014 does not apply to coatings made of other materials than unalloyed titanium or coatings realized by another technology than plasma spraying.
|
Withdrawn |
2014-06 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13179-1:2021 |
Implants for surgery — Coatings on metallic surgical implants — Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
This document specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants.
This document applies to atmospheric plasma spraying and vacuum plasma spraying.
This document does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying.
NOTE A quality management system can be useful, e.g. as described in ISO 13485. Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
|
Published |
2021-09 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13356:1997 |
Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
|
Withdrawn |
1997-09 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13356:2008 |
Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
ISO 13356:2008 specifies the characteristics of, and corresponding test methods for, a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as material for surgical implants.
|
Withdrawn |
2008-06 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13356:2015 |
Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
ISO 13356:2015 specifies the requirements and corresponding test methods for a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants.
|
Published |
2015-09 |
Edition : 3 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 13404-1 |
Prosthetics and orthotics — External orthoses and orthotic components — Uses, functions, classification and description — Part 1: Lower limb orthosis |
ISO 13404:2007 establishes a means of classifying and describing external orthoses and the components from which they are assembled.
|
Under development |
|
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13404:2007 |
Prosthetics and orthotics — Categorization and description of external orthoses and orthotic components |
ISO 13404:2007 establishes a means of classifying and describing external orthoses and the components from which they are assembled.
|
Published |
2007-07 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13405-1:1996 |
Prosthetics and orthotics — Classification and description of prosthetic components — Part 1: Classification of prosthetic components |
Contains a means of classifying the components of limb prostheses and their construction.
|
Withdrawn |
1996-10 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13405-1:2015 |
Prosthetics and orthotics — Classification and description of prosthetic components — Part 1: Classification of prosthetic components |
ISO 13405-1:2015 specifies a means of classifying the components of limb prostheses and their construction.
|
Published |
2015-01 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13405-2:1996 |
Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower-limb prosthetic components |
Establishes a method for describing lower-limb prosthetic components.
|
Withdrawn |
1996-10 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13405-2:2015 |
Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower limb prosthetic components |
ISO 13405-2:2015 specifies a method for describing lower limb prosthetic components.
|
Published |
2015-01 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13405-3:1996 |
Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper-limb prosthetic components |
Establishes a method for describing upper-limb prosthetic components.
|
Withdrawn |
1996-10 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13405-3:2015 |
Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper limb prosthetic components |
ISO 13405-3:2015 specifies a method for describing upper-limb prosthetic components.
|
Published |
2015-01 |
Edition : 2 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-1:2000 |
Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite |
|
Withdrawn |
2000-08 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-1:2008 |
Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite |
ISO 13779-1:2008 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants.
It applies to hydroxyapatite blocks.
ISO 13779-1:2008 does not apply to hydroxyapatite coatings, hydroxyapatite powder or nanoparticle-type and calcium phosphate ceramics which are not mainly composed of crystalline hydroxyapatite.
|
Withdrawn |
2008-10 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-2:2000 |
Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite |
|
Withdrawn |
2000-08 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-2:2009 |
Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
ISO 14243-2:2009 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243-1.
|
Withdrawn |
2009-11 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-2:2008 |
Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite |
ISO 13779-2:2008 specifies requirements for ceramic hydroxyapatite coatings applied to metallic or non-metallic surgical implants.
ISO 13779-2:2008 does not cover coatings made from glasses, glass ceramics, alpha- and beta-calcium orthophosphate or other forms of calcium phosphate, nor does it cover coatings in which the hydroxyapatite is present in a powder form.
|
Withdrawn |
2008-10 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-2:2018 |
Implants for surgery — Hydroxyapatite — Part 2: Thermally sprayed coatings of hydroxyapatite |
This document specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants.
These requirements are intended to describe properties of the materials and to communicate these between organizations. These requirements are not written with the objective of replacing a company's internal operational and assessment requirements although they could be used as such.
NOTE 1 For thin coatings with a thickness of less than 50 µm, some of the test methods described in this document might be difficult to apply without modification.
NOTE 2 The requirements of the hydroxyapatite layer of dual-layer coatings (consisting of a lower layer of metallic coating and an upper layer of hydroxyapatite coating) can follow this document; however, testing methods referred to in this document cannot be applied to dual layer coatings. If this document is taken in reference for the requirements of the hydroxyapatite layer of dual layer coatings, a rationale on how the single-layer tested coupons are representative of the dual-layer coated implant might be considered necessary.
This document does not cover coatings made from glasses, glass ceramics, alpha- and beta-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate.
NOTE 3 While the requirements in this document are intended to be used as specifications of a thermally sprayed coating of hydroxyapatite, it might be necessary to establish routine control procedures specifying control tests and their time intervals to make sure the characteristics of the coating stay within specified limits.
NOTE 4 This document was developed with a focus on plasma sprayed coating of hydroxyapatite. It might also be used to characterize other thermally sprayed coatings of hydroxyapatite. However, thermally sprayed coatings that do not have a history of clinical use might present different risks and might need additional characterizations beyond those identified in this document.
|
Published |
2018-12 |
Edition : 3 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-3:2008 |
Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity and phase purity |
ISO 13779-3:2008 specifies methods of test for the chemical analysis and assessment of crystallinity and phase composition of hydroxyapatite-based materials such as coatings and sintered products.
|
Withdrawn |
2008-02 |
Edition : 1 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-3:2018 |
Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity |
This document specifies methods of test for the chemical analysis, assessment of crystallinity ratio and phase composition of hydroxyapatite-based materials such as powders, coating or bulk products.
NOTE These tests are intended to describe properties of the material and to communicate these between organizations. These tests are not written with the objective of replacing a company's internal operational and assessment tests although they could be used as such.
|
Published |
2018-12 |
Edition : 2 |
Number of pages : 32 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-3:2018/Amd 1:2021 |
Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity — Amendment 1 |
|
Published |
2021-03 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-4:2002 |
Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength |
This part of ISO 13779 specifies test methods for measurement of the adhesion strength of hydroxyapatite coatings intended for use on components of surgical implants.
|
Withdrawn |
2002-05 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-4:2018 |
Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength |
This document specifies a test method for measurement of the adhesion strength of hydroxyapatite coatings intended for use on metallic-substrate components of surgical implants.
NOTE Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
|
Published |
2018-12 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13779-6:2015 |
Implants for surgery — Hydroxyapatite — Part 6: Powders |
ISO 13779-6:2015 specifies requirements for hydroxyapatite powders used as a raw material for the manufacturing of surgical implants or coating of surgical implants.
ISO 13779-6:2015 does not apply to hydroxyapatite coatings, ceramic hydroxyapatite, glass ceramics, α- and β-tricalcium phosphate, or other forms of calcium phosphate.
|
Published |
2015-01 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13781:1997 |
Poly(L-lactide) resins and fabricated forms for surgical implants — In vitro degradation testing |
Describes methods for the determination of chemical and mechanical changes in properties of poly(L-lactide) under in vitro degradation testing conditions.The poly L-lactid is used for the manufacture of surgical implants. The purpose is to compare and/or evaluate materials or processing conditions.
|
Withdrawn |
1997-01 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9120:1997/Amd 1:2019 |
Petroleum and related products — Determination of air-release properties of steam turbine and other oils — Impinger method — Amendment 1 |
|
Published |
2019-12 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
75.100
Lubricants, industrial oils and related products
|
| ISO 13781:2017 |
Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
ISO 13781:2017 describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.
The purpose of this document is to compare and/or evaluate materials or processing conditions. This document also describes the fundamental physical and mechanical evaluations needed for an in vitro degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device.
ISO 13781:2017 is applicable to poly(lactide)-based homopolymers, copolymers and/or blends in bulk or processed forms and used for the manufacture of surgical implants, including finished products (packaged and sterilized implants).
The test methods specified in this document are also intended to determine the in vitro degradation rate and related changes in material properties of polylactide-based copolymers and/or blends with various other comonomers, such as glycolid, trimethylene, carbonate and/or ε-caprolactone. Unless otherwise validated for a specific device, these in vitro methods cannot be used to definitively predict device behaviour under in vivo conditions.
|
Published |
2017-07 |
Edition : 2 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13782:1996 |
Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications |
Specifies the characteristics of, and corresponding test methods for, unalloyed tantalum in form of sheets, rods and wires used in the manufacture of surgical implants.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13782:2019 |
Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications |
This document specifies the characteristics of, and corresponding test methods for, unalloyed tantalum sheet, rod and wire used in the manufacture of surgical implants.
NOTE 1 Provision is made for two grades of tantalum.
|
Published |
2019-04 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13958:2002 |
Concentrates for haemodialysis and related therapies |
This International Standard is applicable to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or haemodiafiltration. It addresses chemical quality and purity, microbial contamination, handling, measurement and labelling of concentrates, the requirements for containers and the tests to monitor concentrates.
This International Standard does not address the final mixing and use of these concentrates and treated water in such therapies. That operation is the sole responsibility of dialysis professionals.
This International Standard is not applicable to dialysing-fluid regeneration systems.
|
Withdrawn |
2002-09 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13958:2009 |
Concentrates for haemodialysis and related therapies |
ISO 13958:2009 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are a mixture of chemicals and water, or a mixture of chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies.
ISO 13958:2009 is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, 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.
ISO 13958:2009 includes concentrates in both liquid and powder forms. Also included are additives also called spikes, chemicals which may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
|
Withdrawn |
2009-04 |
Edition : 2 |
Number of pages : 22 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13958:2014 |
Concentrates for haemodialysis and related therapies |
ISO 13958:2014 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of ISO 13958:2014, "concentrates" are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. ISO 13958:2014 is addressed to the manufacturer of such concentrates.
ISO 13958:2014 includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. ISO 13958:2014 also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
|
Withdrawn |
2014-04 |
Edition : 3 |
Number of pages : 26 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-1:2002 |
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
This part of ISO 14242 specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total hip-joint prostheses.
|
Withdrawn |
2002-03 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13959:2002 |
Water for haemodialysis and related therapies |
This International Standard specifies minimum requirements for water to be used in the preparation of concentrates and dialysing fluids for haemodialysis and haemodiafiltration.
This International Standard does not address the operation of water treatment equipment nor the final mixing of treated water with concentrates to produce the fluids used in such therapies. That operation is the sole responsibility of dialysis professionals.
This International Standard is not applicable to dialysing-fluid regenerating systems.
|
Withdrawn |
2002-09 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13959:2009 |
Water for haemodialysis and related therapies |
ISO 13959:2009 specifies minimum requirements for water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and for the reprocessing of haemodialysers.
ISO 13959:2009 does not address the operation of water treatment equipment nor the final mixing of treated water with concentrates to produce the dialysis fluids used in such therapies. That operation is the sole responsibility of dialysis professionals.
ISO 13959:2009 does not apply to dialysis fluid regenerating systems.
|
Withdrawn |
2009-04 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13959:2014 |
Water for haemodialysis and related therapies |
ISO 13959:2014 specifies minimum requirements for water to be used in haemodialysis and related therapies.
ISO 13959:2014 includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
|
Withdrawn |
2014-04 |
Edition : 3 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13960:2003 |
Cardiovascular implants and artificial organs — Plasmafilters |
ISO 13960:2003 specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
ISO 13960:2003 is not applicable to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices.
ISO 13960:2003 does not address the replacement fluid.
|
Withdrawn |
2003-12 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 13960:2010 |
Cardiovascular implants and extracorporeal systems — Plasmafilters |
ISO 13960:2010 specifies requirements for sterile, single use plasmafilters, intended for use on humans.
|
Withdrawn |
2010-07 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14117:2012 |
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
ISO 14117:2012 specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization.
It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:
0 Hz ≤ f < 450 MHz;
450 MHz ≤ f ≤ 3 000 MHz.
ISO 14117:2012 also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
|
Withdrawn |
2012-07 |
Edition : 1 |
Number of pages : 97 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
;
33.100.01
Electromagnetic compatibility in general
|
| ISO 14117:2019 |
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems.
NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:
— 0 Hz ≤ ? < 385 MHz;
— 385 MHz ≤ ? ≤ 3 000 MHz
This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
|
Published |
2019-09 |
Edition : 2 |
Number of pages : 134 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
;
33.100.01
Electromagnetic compatibility in general
|
| ISO 14243-2:2000 |
Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
|
Withdrawn |
2000-10 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-1:2012 |
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
ISO 14242-1:2012 specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration and the test environment to be used for the wear testing of total hip-joint prostheses.
|
Withdrawn |
2012-01 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-1:2014 |
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
ISO 14242-1:2014 specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration, and the test environment to be used for the wear testing of total hip-joint prostheses.
|
Published |
2014-10 |
Edition : 3 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-1:2014/Amd 1:2018 |
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test — Amendment 1 |
|
Published |
2018-07 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-2:2000 |
Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
|
Withdrawn |
2000-09 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-2:2016 |
Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
ISO 14242-2:2016 specifies methods of assessment of wear of the acetabular component of total hip-joint prostheses using gravimetric techniques and changes in dimensional form of components tested in accordance with ISO 14242‑1 or ISO 14242‑3 as appropriate.
|
Published |
2016-09 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-3:2009 |
Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test |
ISO 14242-3:2009 specifies relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the orbital bearing type wear testing of total hip joint prostheses.
|
Published |
2009-03 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-3:2009/Amd 1:2019 |
Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test — Amendment 1 |
|
Published |
2019-01 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14242-4:2018 |
Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
This document specifies the test conditions to simulate edge loading in hip prostheses due to steep acetabular cup inclination angle and dynamic separation conditions.
This document is used in conjunction with ISO 14242‑1 or ISO 14242‑3.
|
Published |
2018-05 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-1:2002 |
Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test |
This part of ISO 14243 specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines with load control.
|
Withdrawn |
2002-03 |
Edition : 1 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-1:2009 |
Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test |
ISO 14243‑1:2009 specifies the flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines with load control.
|
Published |
2009-11 |
Edition : 2 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-1:2009/Amd 1:2020 |
Implants for surgery — Wear of total knee-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test — Amendment 1 |
|
Published |
2020-01 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-2:2016 |
Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
ISO 14243-2:2016 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243‑1 or ISO 14243‑3 as appropriate.
|
Published |
2016-09 |
Edition : 3 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-3:2004 |
Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test |
ISO 14243-3:2004 specifies relative movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control.
The kinematics of ISO 14243-3:2004 may not be applicable to knee designs with a high degree of constraint, which could result in damage to the articulating components in the early stages of the test that would not be representative of clinical service.
|
Withdrawn |
2004-09 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-3:2004/Cor 1:2006 |
Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test — Technical Corrigendum 1 |
|
Withdrawn |
2006-02 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-3:2014 |
Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test |
ISO 14243-3:2014 describes a test method that specifies flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control.
The kinematics of this part of ISO 14243-3:2014 may not be applicable to knee designs with a high degree of constraint, which could result in damage to the articulating components in the early stages of the test that would not be representative of clinical service.
|
Published |
2014-11 |
Edition : 2 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-3:2014/Amd 1:2020 |
Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test — Amendment 1 |
|
Published |
2020-01 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14243-5:2019 |
Implants for surgery — Wear of total knee prostheses — Part 5: Durability performance of the patellofemoral joint |
This document specifies the relative angular movement between articulating patellofemoral joint components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the durability testing of total knee-joint prostheses in wear-testing machines with load control and displacement.
|
Published |
2019-05 |
Edition : 1 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 14283:1995 |
Implants for surgery — Fundamental principles |
Provides fundamental principles for the design and manufacture of active or non-active implants in order to achieve the intended purpose.
|
Withdrawn |
1995-03 |
Edition : 1 |
Number of pages : 18 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 14283:2004 |
Implants for surgery — Fundamental principles |
ISO/TR 14283 provides fundamental principles for the design and manufacture of active or non-active implants in order to achieve the intended purpose.
|
Withdrawn |
2004-07 |
Edition : 2 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 14283:2018 |
Implants for surgery — Essential principles of safety and performance |
ISO/TR 14283:2017 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose.
ISO/TR 14283:2017 is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices.
Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.
|
Published |
2018-01 |
Edition : 3 |
Number of pages : 20 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14602:1998 |
Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
|
Withdrawn |
1998-05 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14602:2010 |
Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.
In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
|
Published |
2010-04 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14607:2002 |
Implants for surgery — Specific requirements for mammary implants |
ISO 14607:2002 provides specific requirements for mammary implants for clinical practice.
With regard to safety, it specifies intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
|
Withdrawn |
2002-11 |
Edition : 1 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14607:2007 |
Non-active surgical implants — Mammary implants — Particular requirements |
ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
|
Withdrawn |
2007-02 |
Edition : 2 |
Number of pages : 28 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14607:2018 |
Non-active surgical implants — Mammary implants — Particular requirements |
ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
|
Published |
2018-04 |
Edition : 3 |
Number of pages : 41 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 14607 |
Non-active surgical implants — Mammary implants — Specific requirements |
|
Under development |
|
Edition : 4 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14630:1997 |
Non-active surgical implants — General requirements |
|
Withdrawn |
1997-10 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|