BC/CLC/02-89 - BC/CLC/02-89

This Part 2-3 of EN 45502 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 European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.

This Part 2-3 of EN 45502 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 European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This Part of EN 45502 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see NOTE 1). The electrical characteristics of the IMPLANTABLE PART shall be determined by either 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 the case of dispute, the method detailed in this particular standard shall apply. 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 part. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This part of EN 45502 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 particular standard 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 Particular Standard shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502-2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers). NOTE 1 The device that is commonly referred

This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This part of EN 45502 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 particular standard 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 Particular Standard shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502–2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers). NOTE 1 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. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined. NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this standard.

EN 45502-2-1:2003 & EN 45502-2-2 will supersede EN 50061:1988 + A1:1995

This Part 2-1 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in EN 45502 are type tests, and are to be carried out on samples of a device to show compliance. This Part 2-1 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 Part 2-1 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 Part 2-1 shall apply. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by EN 45502-2-2. NOTE 1 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. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

This Part 1 of EN 45502 specifies requiremnets that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The test that are specified in EN 45502 are type tests and are to be carries out on samples of a device to show compliance. This Part of EN 45502 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.). This Part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see note 1). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICES 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 safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in SMALL CAPITAL LETTERS are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

Corrigendum to EN issued November 1993

This European standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requirements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential features, such as the means of fastening the connector assembly, or the materials of construction. WARNING The connector cavity specified in this standard is not to be used with an implantable device if that device is capable of introducing dangerous non-pacing signals (e.g. defibrillation signals) through an IS-1 connector. This European standard supplements EN 50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN 50061 regarding leads.

Corrigendum to EN/A1 issued October 1995

To be implemented in all countries except AT & NO * Will be superseded by EN 45502-2-1 (pr=7407) & EN 45502-2-2 (pr=8622)

Superseded by EN 60601-2-4:2003

prEN 61272 after parallel vote (failed) ratified in CLC as EN 50103 and withheld in IEC

The guidelines contained in this European Standard are applicable to a QUALITY SYSTEM as specified by EN 29001 and EN 46001 or EN 29002 and EN 46002. This European Standard does not add to, or otherwise change the requirements of those standards, and is not intended to be used directly in the assessment of a SUPPLIER' s QUALITY SYSTEM. The guidelines provide concepts and objectives which should be considered by a SUPPLIER of ACTIVE MEDICAL DEVICES while developing and maintaining his QUALITY SYSTEM. This European Standard: - provides examples of how to meet the requirements, while recognizing that other methods which achieve the same ends are equally acceptable; - gives general advice on how to meet the requirements; - draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with QUALITY SYSTEMS used in the ACTIVE MEDICAL DEVICE industry.

This Part 1 of EN 45502 specifies requiremnets that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The test that are specified in EN 45502 are type tests and are to be carries out on samples of a device to show compliance. This Part of EN 45502 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.). This Part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see note 1). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICES 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 safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in SMALL CAPITAL LETTERS are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

Corrigendum to EN/A1 issued October 1995

Specifies requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors incorporating a capacitive energy storage device.

This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac Pacemakers. This standard also establishes basic terminology and definitions and includes requirements for the marking of pacemakers and their packaging. In addition, minimum requirements are specified for the ability of pacemakers to withstand environmental stress conditions. Appropriate test methods are given. This standard specifies the requirements for the reliable operation of pacemakers only insofar as they affect safety. It does not cover the antitachyarrythmia and defibrillation functions of pacemakers, nor pacemakers operated by isotopic cells