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EN 45502-2-1:2003 Standard

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  Keywords:

#method #tests #specified #detailed #implantable

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

  Purpose

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.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 10993-4:2009

Active implantable medical devices Directive (90/385/EEC)

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EN 60601-1:2006/A1:2013

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Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN 45502-2-3:2010

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Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

EN 45502-2-2:2008/AC:2009

Active implantable medical devices Directive (90/385/EEC)

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

EN 45502-2-2:2008

Active implantable medical devices Directive (90/385/EEC)

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

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