| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO 14630:2005 |
Non-active surgical implants — General requirements |
ISO 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.
With regard to safety, ISO 14630:2005 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.
|
Withdrawn |
2005-05 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14630:2008 |
Non-active surgical implants — General requirements |
ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.
|
Withdrawn |
2008-01 |
Edition : 3 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14630:2012 |
Non-active surgical implants — General requirements |
ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
|
Published |
2012-12 |
Edition : 4 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 14630 |
Non-active surgical implants — General requirements |
|
Under development |
|
Edition : 5 |
Number of pages : 27 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-1:2000 |
Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
|
Withdrawn |
2000-11 |
Edition : 1 |
Number of pages : 40 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-1:2014 |
Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance.
ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).
ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.
|
Published |
2014-08 |
Edition : 2 |
Number of pages : 57 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-2:2005 |
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers |
ISO 14708-2:2005 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias (cardiac pacemakers).
The tests that are specified in ISO 14708-2:2005 are type tests, and are to be carried out on samples of a device to show compliance.
ISO 14708-2:2005 is also applicable to some non-implantable parts and accessories of the devices. The device that is commonly referred to as an active implantable medical device may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
The characteristics of the implantable pulse generator or lead are to be determined by either the appropriate method detailed in ISO 14708-2:2005 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in ISO 14708-2:2005 is applicable.
|
Withdrawn |
2005-10 |
Edition : 1 |
Number of pages : 96 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-2:2012 |
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers |
ISO 14708-2:2012 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias.
The tests that are specified in ISO 14708-2:2012 are type tests, and are to be carried out on samples of a device to show compliance.
ISO 14708-2:2012 is also applicable to some non-implantable parts and accessories of the devices.
|
Withdrawn |
2012-08 |
Edition : 2 |
Number of pages : 68 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-2:2019 |
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers |
This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
|
Published |
2019-09 |
Edition : 3 |
Number of pages : 71 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-3:2008 |
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
ISO 14708-3:2008 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
ISO 14708-3:2008 is also applicable to all non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-3:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.
|
Withdrawn |
2008-11 |
Edition : 1 |
Number of pages : 45 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-3:2017 |
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
|
Published |
2017-04 |
Edition : 2 |
Number of pages : 54 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-4:2008 |
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps |
ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-4:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.
|
Withdrawn |
2008-11 |
Edition : 1 |
Number of pages : 42 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-4:2022 |
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems |
This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1.
This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3.
The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products.
NOTE This document is not intended to apply to non-implantable infusion systems.
|
Published |
2022-02 |
Edition : 2 |
Number of pages : 58 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-5:2010 |
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices |
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
|
Withdrawn |
2010-02 |
Edition : 1 |
Number of pages : 47 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-5:2020 |
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices |
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.
Included in the scope of this document are:
— ventricular assist devices (VAD), left or right heart support;
— total artificial hearts (TAH);
— biventricular assist devices (biVAD);
— percutaneous assist devices;
— paediatric assist devices.
|
Published |
2020-05 |
Edition : 2 |
Number of pages : 69 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-6:2010 |
Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
ISO 14708-6:2010 specifies requirements that are applicable to implantable cardioverter defibrillators and the functions of active implantable medical devices intended to treat tachyarrhythmia.
ISO 14708-6:2010 is also applicable to some non-implantable parts and accessories of the devices.
|
Withdrawn |
2010-03 |
Edition : 1 |
Number of pages : 110 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-6:2019 |
Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
|
Published |
2019-09 |
Edition : 2 |
Number of pages : 66 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14708-7:2013 |
Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems |
ISO 14708-7:2013 specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways.
The tests that are specified in ISO 14708-7:2013 are type tests and are to be carried out on samples of a device to show compliance.
ISO 14708-7:2013 is also applicable to non-implantable parts and accessories of the devices.
|
Withdrawn |
2013-01 |
Edition : 1 |
Number of pages : 54 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 1122-1:1998/Cor 2:2009 |
Vocabulary of gear terms — Part 1: Definitions related to geometry — Technical Corrigendum 2 |
|
Published |
2009-06 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
21.200
Gears
;
01.040.21
Mechanical systems and components for general use (Vocabularies)
|
| ISO 14708-7:2019 |
Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document.
The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance.
This document is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
|
Published |
2019-12 |
Edition : 2 |
Number of pages : 68 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14879-1:2000 |
Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays |
|
Withdrawn |
2000-06 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14879-1:2020 |
Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays |
This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia.
The test method does not apply to tibial components manufactured solely from plastic materials.
This document does not cover methods of examining and reporting the final condition of the test specimen; these can be the subject of agreement between the test laboratory and the parties submitting the specimen for test.
NOTE Correlation of test results with in vivo performance has not been established.
|
Published |
2020-07 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 14949:2001 |
Implants for surgery — Two-part addition-cure silicone elastomers |
This International Standard specifies the characteristics of, and corresponding test methods for, the two-part
addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical
implants.
|
Published |
2001-10 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15032:2000 |
Prostheses — Structural testing of hip units |
This International Standard specifies test methods for components and assemblies of hip disarticulation prostheses
which are arranged at hip and thigh level. It does not apply to other components of lower limb prostheses for which
test methods are given in ISO 10328.
This International Standard specifies procedures for simplified static and cyclic strength tests in which the anteroposterior
(A-P) and medio-lateral (M-L) components of loading are produced in separate tests by the application of
test forces in two different test planes. The components of loading produced 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 |
2000-04 |
Edition : 1 |
Number of pages : 38 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15142-1:2003 |
Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails |
ISO 15142-1:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, defining terms and giving requirements for intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body.
|
Published |
2003-08 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 15142-1 |
Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails |
|
Deleted |
|
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15142-2:2003 |
Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components |
ISO 15142-2:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving requirements for the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails.
|
Published |
2003-08 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 15142-2 |
Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components |
|
Deleted |
|
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15142-3:2003 |
Implants for surgery — Metal intramedullary nailing systems — Part 3: Connection devices and reamer diameter measurements |
ISO 15142-3:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving other requirements and dimensions for the devices used to insert, remove or both insert and remove intramedullary nails. It also provides a means of measuring reamer diameter. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except drive connections for locking elements.
|
Published |
2003-08 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 15142-3 |
Implants for surgery — Metal intramedullary nailing systems — Part 3: Connection devices and reamer diameter measurements |
|
Deleted |
|
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15309:2013 |
Implants for surgery — Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices |
ISO 15309:2013 specifies a method for the thermal analysis of Poly Ether Ether Ketone (PEEK) that is for use in the manufacture of implantable medical devices, using differential scanning calorimetry (DSC).
The transition temperatures to be determined are the glass transition temperature (Tg), the melting temperature (Tm) and the crystallization temperature on cooling (Tc).
|
Published |
2013-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15374:1998 |
Implants for surgery — Requirements for production of forgings |
|
Published |
1998-08 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 15539:2000 |
Cardiovascular implants — Endovascular prostheses |
|
Withdrawn |
2000-10 |
Edition : 1 |
Number of pages : 23 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15674:2001 |
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
|
Withdrawn |
2001-11 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15674:2009 |
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
ISO 15674:2009 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.
ISO 15674:2009 applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
|
Withdrawn |
2009-04 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15674:2016 |
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
ISO 15674:2016 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.
It applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
|
Published |
2016-08 |
Edition : 3 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15674:2016/Amd 1:2020 |
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors |
|
Published |
2020-02 |
Edition : 3 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15675:2001 |
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters |
|
Withdrawn |
2001-10 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15675:2009 |
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
ISO 15675:2009 specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.
|
Withdrawn |
2009-04 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21065:2017 |
Prosthetics and orthotics — Terms relating to the treatment and rehabilitation of persons having a lower limb amputation |
ISO 21065:2017 specifies a vocabulary for the description of the phases of treatment and rehabilitation of persons having a lower limb amputation and the treatments which are used during these phases.
|
Published |
2017-07 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15675:2016 |
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
ISO 15675:2016 specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.
|
Published |
2016-08 |
Edition : 3 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15675:2016/Amd 1:2020 |
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors |
|
Published |
2020-02 |
Edition : 3 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15676:2005 |
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) |
ISO 15676:2005 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). ISO 15676:2005 is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. < 6 h duration) CPB surgery, or (long-term, i.e. > 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of ISO 15676:2005 are applicable to tubing packs labelled as "sterile".
ISO 15676:2005 is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
|
Withdrawn |
2005-07 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15676:2016 |
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) |
ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile".
It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
|
Published |
2016-08 |
Edition : 2 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 15814:1999 |
Implants for surgery — Copolymers and blends based on polylactide — In vitro degradation testing |
|
Withdrawn |
1999-11 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16054:2000 |
Implants for surgery — Minimum data sets for surgical implants |
|
Withdrawn |
2000-12 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16054:2019 |
Implants for surgery — Minimum data sets for surgical implants |
This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.
This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.
This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.
It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.
|
Published |
2019-07 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16061:2000 |
Instrumentation for use in association with non-active surgical implants — General requirements |
|
Withdrawn |
2000-03 |
Edition : 1 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
;
11.040.99
Other medical equipment
|
| ISO/TR 21900:2018 |
Guidance for uncertainty analysis regarding the application of ISO/TS 10974 |
This document provides guidance for some methods that could be used to evaluate the sources of uncertainty. It is important to note that there are many legitimate methods for analyzing the overall uncertainty and that the methods in this document are illustrative only.
|
Published |
2018-09 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16061:2008 |
Instrumentation for use in association with non-active surgical implants — General requirements |
ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
|
Withdrawn |
2008-12 |
Edition : 2 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
;
11.040.99
Other medical equipment
|
| ISO 16061:2015 |
Instrumentation for use in association with non-active surgical implants — General requirements |
ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
|
Withdrawn |
2015-05 |
Edition : 3 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
;
11.040.99
Other medical equipment
|
| ISO 16061:2021 |
Instruments for use in association with non-active surgical implants — General requirements |
This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
|
Published |
2021-03 |
Edition : 4 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
;
11.040.99
Other medical equipment
|
| ISO 16087:2013 |
Implants for surgery — Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
ISO 16087:2013 provides requirements for the clinical assessment of migration of orthopaedic implants with roentgen stereophotogrammetric analysis (RSA).
|
Published |
2013-10 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 16379:2014 |
Tissue-engineered medical products — Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging |
ISO/TR 16379:2014 has been prepared for evaluation of therapeutic courses for articular cartilage disease and summarizes results from structural evaluation of knee joint cartilage by diffusion tensor imaging, an MRI applied technology allowing non-invasive observation of soft tissue morphology in vivo.
ISO/TR 16379:2014 is intended for use in areas such as regenerative medicine for knee joint cartilage disease.
|
Published |
2014-03 |
Edition : 1 |
Number of pages : 23 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16402:2008 |
Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics |
ISO 16402:2008 applies to resin cements based on poly(methacrylic acid esters) and specifies the procedure for determining the fatigue behaviour of the polymerized cement.
|
Published |
2008-05 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16428:2005 |
Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.
These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests.
Typical articulating joint simulator tests and aspects particular to the dental field are not considered by ISO 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ISO 16428:2005.
|
Published |
2005-04 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 16429:2004 |
Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods |
ISO 16429:2004 specifies a test method for measurements over extended time periods of the open-circuit potential of implant materials and surgically implantable devices immersed in a test environment related to body fluid, using a standard corrosion test cell to study the electrochemical corrosion properties of the devices.
This method of monitoring the open-circuit potential can also be combined with mechanical static or dynamic loading tests.
ISO 16429:2004 is applicable in particular to metallic materials which form passive layers with protective properties against corrosion, as typical for surgical implant materials.
This test method is intended for the investigation of single metallic materials or alloys. It is not applicable to dissimilar material combinations, which require particular considerations in measuring and interpreting the results.
|
Published |
2004-07 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 16955:2016 |
Prosthetics — Quantification of physical parameters of ankle foot devices and foot units |
ISO/TS 16955:2016 describes quantitative methods to evaluate or assess key performance indicators of prosthetic ankle foot devices.
For each method, the set-up and test configurations are described. Also included is a variety of parameters which are derived or calculated from the recorded data.
|
Published |
2016-06 |
Edition : 1 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 17137:2014 |
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants |
ISO/TS 17137:2014 outlines design verification and validation considerations for absorbable cardiovascular implants.
ISO/TS 17137:2014 is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. ISO/TS 17137:2014 does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 17137:2014 if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate 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 implant and supports the primary mode of action of the implant.
|
Withdrawn |
2014-05 |
Edition : 1 |
Number of pages : 26 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 17137:2019 |
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants |
This document outlines design evaluation guidelines for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is meant to supplement device-specific standards by providing guidelines specific for absorbable implants and/or components
This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non- viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of This document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate 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 implant and supports the primary mode of action of the implant.
|
Withdrawn |
2019-09 |
Edition : 2 |
Number of pages : 29 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 17137:2021 |
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants |
This document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both.
This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of this document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant can incorporate 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 implant and supports the primary mode of action of the implant.
NOTE 1 Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1.
NOTE 2 An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A.
|
Published |
2021-09 |
Edition : 3 |
Number of pages : 36 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18192-1:2011 |
Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test |
ISO 18192-1:2011 defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses.
Both lumbar and cervical prostheses are addressed.
|
Published |
2011-03 |
Edition : 2 |
Number of pages : 26 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 17327-1:2018 |
Non-active surgical implants — Implant coating — Part 1: General requirements |
ISO 17327-1:2018 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This document specifies requirements concerned with generic coating properties including chemical and phase compositions, surface texture, coating coverage integrity, dissolvability, coating thickness, adhesion strength, abrasion resistance, porosity and pore size, and surface wettability.
ISO 17327-1:2018 is applicable to surface coatings, which are defined as layers of material with any different property than the natural surface of the substrate which are intentionally added to the substrate.
ISO 17327-1:2018 is applicable to surface modifications, which are defined as intentional conversion or reconstruction of the surface of the original substrate to form a new surface material consisting of components of the substrate's own material and possibly foreign material and forming a surface layer with different properties.
Since the pertinent properties of a coating and their needed level of characterization are highly dependent on the intended application of the implant, the generic nature of the general requirements in this document is not intended to either override or replace the provisions of application-specific performance standards.
ISO 17327-1:2018 is not applicable to surfaces modified by texturing with the exclusive intention to change the roughness of the surface or the strength of the raw material.
ISO 17327-1:2018 is not applicable to natively passivated metal surfaces. While this document is applicable to intentionally passivated metal surfaces, well-established materials passivated by conventional techniques, such as nitric acid immersion, are usually non-hazardous and can be described in a very basic manner.
ISO 17327-1:2018 is not applicable to implant coatings utilizing viable tissue.
ISO 17327-1:2018 is not applicable to laminates, i.e. composite materials made of multiple layers, e.g. vascular prosthesis constructed of different expanded polytetrafluoroethylene layers, except the exposed surface of the laminate, which can be an implant coating (see 3.1, note 2 to entry).
ISO 17327-1:2018 is not applicable to coverings, e.g. covered stents.
NOTE 1 ISO 17327-1:2018 does not contain requirements on biocompatibility. Nevertheless, this is a critical property of the device and coating and needs to be addressed during risk assessment.
NOTE 2 ISO 17327-1:2018 supplements applicable non-active surgical implant standards and ISO 14630.
NOTE 3 ISO 17327-1:2018 does not require that manufacturers have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.
NOTE 4 Although fully porous implants are not coatings, some of the considerations in this document can also be applied to them.
|
Published |
2018-02 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 17327-2:2021 |
Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings |
This document provides lists of reference standards which contain general information, implant device or application-specific information, material specifications, or test methods related to coatings. These reference standards can be used to develop product coatings for specified applications when using ISO 17327-1 to address general coating requirements.
This document is applicable to coatings on non-active surgical implants.
|
Published |
2021-04 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 17853:2003 |
Wear of implant materials — Polymer and metal wear particles — Isolation, characterization and quantification |
ISO 17853:2003 specifies methods for sampling wear debris generated by total joint prostheses in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate, characterize and quantify both polymer and metal wear debris from samples of tissue excised from around the joint prosthesis, obtained at revision surgery or post mortem, and from samples of joint-simulator test fluids.
The method given in ISO 17853:2003 does not quantify the level of wear the implant produces, nor does it determine the amount of wear from any particular surface. ISO 17853:2003 does not cover the biological effect of wear debris or provide a method for evaluation of biological safety.
The method given in ISO 17853:2003 is not applicable to the measurement of poly(methyl methacrylate) (PMMA) debris.
|
Withdrawn |
2003-07 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 17853:2003/Cor 1:2004 |
Wear of implant materials — Polymer and metal wear particles — Isolation, characterization and quantification — Technical Corrigendum 1 |
|
Withdrawn |
2004-02 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 17853:2010 |
Wear of implant materials — Polymer and metal wear particles — Isolation and characterization |
ISO 17853:2010 specifies methods for sampling wear particles generated by joint implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissue excised from around the joint implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).
|
Withdrawn |
2010-06 |
Edition : 2 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 17853:2011 |
Wear of implant materials — Polymer and metal wear particles — Isolation and characterization |
ISO 17853:2011 specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised from around the joint replacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).
|
Published |
2011-03 |
Edition : 3 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18192-1:2008 |
Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test |
ISO 18192-1:2008 defines a test procedure for the relative angular movement between articulating components, and specifies 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 intervertebral spinal disc prostheses.
Both lumbar and cervical prostheses are addressed.
|
Withdrawn |
2008-01 |
Edition : 1 |
Number of pages : 25 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18192-2:2010 |
Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 2: Nucleus replacements |
ISO 18192‑2:2010 defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192‑1.
ISO 18192‑2:2010 is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint replacements. The method includes wear and fatigue testing. Additional mechanical tests such as creep tests can be required.
ISO 18192‑2:2010 does not reproduce the complex in vivo loads and motions. The wear and fatigue data obtained with this test method will enable comparison between different types of implant but can differ from the clinical wear performance. The user of ISO 18192‑2:2010 should consider running additional tests addressing specific safety issues of the individual implant design to be tested.
|
Published |
2010-06 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18192-3:2017 |
Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
ISO 18192-3:2017 defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions.
|
Published |
2017-06 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18193:2021 |
Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation |
This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard does not apply to:
— introducers (e.g., guidewires) as addressed in ISO 11070,
— isolated organ perfusion cannulae, and
— intravascular catheters as addressed in ISO 10555-3.
|
Published |
2021-08 |
Edition : 1 |
Number of pages : 33 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18241:2016 |
Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps |
ISO 18241:2016 specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.
|
Published |
2016-08 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18241:2016/Amd 1:2019 |
Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors |
|
Published |
2019-12 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18242:2016 |
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps |
ISO 18242:2016 specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.
It does not apply to
- centrifugal pumps used as ventricular assist devices, and
- other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
|
Published |
2016-09 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18242:2016/DAmd 1 |
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing |
|
Under development |
|
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 19024:2016 |
Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass |
ISO/TR 19024:2016 recommends acceptable methodology for conducting gaseous microemboli (GME) testing and discusses limitations of current test methods. Tests described in ISO/TR 19024:2016 are limited to those conducted using an in vitro circulatory system.
It is applicable to all devices intended for extracorporeal circulatory support during cardiopulmonary bypass (CPB). It outlines approaches currently used to assess the ability of CPB devices to handle GME.
|
Published |
2016-09 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21917:2021 |
Anaesthetic and respiratory equipment — Voice prostheses |
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE There is guidance or rationale for this list item contained in A.2.
|
Published |
2021-08 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.10
Anaesthetic, respiratory and reanimation equipment
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 19090:2018 |
Tissue-engineered medical products — Bioactive ceramics — Method to measure cell migration in porous materials |
ISO 19090:2018 specifies the test method to be followed for measuring and documenting the cell migration ability of porous bioactive ceramic materials.
ISO 19090:2018 is not applicable to porous materials that have low or no cell adhesion properties, for instance synthetic polymers and metals. These types of materials will require longer times to allow effective transfer and migration of cells from the cultured substrate to the test specimen. To minimize influences of cell passages, cell kinds, differences in cell culture consumables including culture medium and fetal bovine serum etc., the method uses a porous bioactive ceramics, which is clinically and widely used in each country, as a reference material for calculation of relative migration distance.
|
Published |
2018-01 |
Edition : 1 |
Number of pages : 33 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 19213:2017 |
Implants for surgery — Test methods of material for use as a cortical bone model |
ISO 19213:2017 specifies mechanical test methods for characterizing cortical bone model materials for use as a standard model for performing mechanical tests for devices or instruments used in orthopaedic surgery, plastic surgery, neurosurgery, and oral and maxillofacial surgery.
The document specifies static mechanical test and properties. Dynamic and viscoelastic/poroelastic tests and properties are not included in the scope of ISO 19213:2017.
|
Published |
2017-07 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 19227:2018 |
Implants for surgery — Cleanliness of orthopedic implants — General requirements |
ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.
ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.
ISO 19227:2018 applies to in-process cleaning and final cleaning.
ISO 19227:2018 does not apply to liquid or gaseous implants.
ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.
|
Published |
2018-03 |
Edition : 1 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 19233-1:2017 |
Implants for surgery — Orthopaedic joint prosthesis — Part 1: Procedure for producing parametric 3D bone models from CT data of the knee |
ISO 19233-1:2017 provides requirements for capturing necessary bone geometries, when using a medical X-ray computed tomography apparatus, to provide the information for applications such as preoperative planning, surgical navigation, robotic surgeries, patient matched instruments and personalized total knee joint prosthesis. The conditions to scan images of bones and the conditions to reconstruct three-dimensional bone models are provided.
NOTE Requirements for the competence of testing laboratories appropriate to help to ensure the reliability and accuracy of the computational measurements can be found in ISO/IEC 17025.
|
Published |
2017-05 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 20160:2006 |
Implants for surgery — Metallic materials — Classification of microstructures for alpha+beta titanium alloy bars |
ISO 20160:2006 provides a catalogue of metallographic photomicrographs for the designation of microstructures of alpha+beta titanium alloys in the form of bars that are intended for the manufacture of surgical implants.
ISO 20160:2006 is applicable to bars of diameter no greater than 100 mm or the equivalent.
|
Published |
2006-05 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 20721:2020 |
Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants |
This document established the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them. This document describes how the evaluation of these metals can differ from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that absorbable metal implants (or subcomponents) are — by design — intended to be absorbed in their entirety by the host.
This document provides guidance regarding the materials considerations, in vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. The provided content is intended to deliver added clarity to the evaluation of these materials and implants to increase awareness of critical factors and reduce potential for generation of erroneous or misleading test results.
While this document and the herein described referenced standards contain many suggested alterations or modifications to currently practiced procedures or specifications, the provided content is intended to complement, and not replace, current conventions regarding the assessment of implantable implants.
This document covers the evaluation of absorbable metal specific attributes in general and is not intended to cover application or implant specific considerations. Thus, it is important to consult relevant implant and/or application specific standards.
This document does not apply to non-absorbable or non-metallic components (e.g. polymeric coatings, pharmaceuticals, non-absorbable metals) used in conjunction with absorbable metal implants.
|
Published |
2020-09 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21063:2017 |
Prosthetics and orthotics — Soft orthoses — Uses, functions, classification and description |
ISO 21063:2017 specifies the uses and functions of soft orthoses. It also classifies and describes the devices and their components. It does not describe the materials or manufacturing methods used for their fabrication.
|
Published |
2017-07 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21064:2017 |
Prosthetics and orthotics — Foot orthotics — Uses, functions classification and description |
ISO 21064:2017 establishes a method of classifying and describing the devices that are used in the field of foot orthotics. It does not describe the materials or manufacturing methods used for their fabrication.
|
Published |
2017-07 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21534:2002 |
Non-active surgical implants — Joint replacement implants — Particular requirements |
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants.
It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
Some tests required to demonstrate compliance with this International Standard are contained in or referenced in level 3 standards.
|
Withdrawn |
2002-11 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21534:2007 |
Non-active surgical implants — Joint replacement implants — Particular requirements |
ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
|
Published |
2007-10 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21535:2007 |
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
ISO 21535:2007 provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
|
Published |
2007-10 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21535:2007/Amd 1:2016 |
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants — Amendment 1 |
|
Published |
2016-11 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/FDIS 21535 |
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
|
Under development |
|
Edition : 3 |
Number of pages : 38 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21536:2002 |
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
This International Standard provides specific requirements for knee-joint replacement implants.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer and methods of test.
|
Withdrawn |
2002-11 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21536:2007 |
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
ISO 21536:2007 provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.
|
Published |
2007-10 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 21536:2007/Amd 1:2014 |
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants — Amendment 1 |
|
Published |
2014-03 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/FDIS 21536 |
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
|
Under development |
|
Edition : 3 |
Number of pages : 34 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TS 21560:2020 |
General requirements of tissue-engineered medical products |
This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy.
This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients (e.g. dialysis with TEMP components). TEMPs containing viable xenogenic cells, genetically modified cells, or cells derived from abnormal cells or tissues (e.g. cancerous tissues) are also excluded from the scope. The combination of TEMPs with medical devices, with the exception of scaffolds comprised of synthetic and/or naturally-derived (e.g. animal sourced) materials, is also excluded from the scope.
NOTE International, national or regional regulations or requirements, or the Pharmacopeia also apply to specific topics covered in this document.
|
Published |
2020-08 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 22523:2006 |
External limb prostheses and external orthoses — Requirements and test methods |
ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
|
Published |
2006-10 |
Edition : 1 |
Number of pages : 82 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 22523 |
External limb prostheses and external orthoses — Requirements and test methods |
|
Under development |
|
Edition : 2 |
Number of pages : 69 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 22622:2019 |
Implants for surgery — Wear of total ankle-joint prostheses — Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
This document 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 ankle-joint prostheses in wear-testing machines with load or displacement control.
NOTE This document is based on the method described by ISO 14243‑1 and ISO 14243‑3 and allows for the use of the same test equipment as for total knee replacement wear testing.
|
Published |
2019-07 |
Edition : 1 |
Number of pages : 25 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 22675:2006 |
Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods |
ISO 22675:2006 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.
In addition, ISO 22675:2006 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, 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.
|
Withdrawn |
2006-10 |
Edition : 1 |
Number of pages : 92 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|