SRPS EN 45502-1:2016

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Scope

This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.
NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.
The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.
This Part 1 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 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.
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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.