EN 45502-1:1997

EN 45502-1:1997 is a standard published by CLC. Its full title is "Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer". This standard covers: 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.

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.

EN 45502-1:1997 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general; 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 45502-1:1997 has the following relationships with other standards: It is inter standard links to EN 45502-1:2015, ISO 8601:1988, EN 540:1993, EN 980:1996, EN 868-1:1997, EN 60068-2-32:1993, EN 60601-1-2:1993, EN 60601-2-27:1994, EN 60601-1-1:1993, EN 60601-1:1990, EN 60601-1-4:1996. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 45502-1:1997 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC; Standardization Mandates: BC/CLC/02-89, M/432, M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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