ISO/TC 150/SC 6 - Active implants

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.

This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions. This document does not specify all connector features. This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system. NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.

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.

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.

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.

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.

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 ≤ ? ≤ 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.

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.

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.

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.

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.

ISO 5841-2:2014 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.

ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods. ISO 5841-3:2013 is applicable only to the form and fit of the connector assembly. ISO 5841-3:2013 supplements ISO 14708‑2 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part.

ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols that comply with the requirements of ISO 27185:2011. ISO 27185:2011 is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling.

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.

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.

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.

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 ≤ 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.

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.

ISO 27186:2010 specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.

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.

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.

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.

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.

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.

Specifies requirements for marking, labelling, packaging and accompanying documentation for implantable neural stimulators intended for stimulation of the nervous system (brain, spinal cord, peripheral nerves and adjacent structures). Also covers implanted or external ancillary components, including the external control and programming equipment used for the activation or adjustment of neural stimulators. Does not specify indications or contraindications for the use of implantable neural stimulators, nor testing or the range of normal operating variable parameters.