BS EN 45502-2-1:2004
Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Standard No.

BS EN 45502-2-1:2004

Release Date

2004

Published By

British Standards Institution (BSI)

Latest

BS EN 45502-2-1:2004

Replace

BS 6902-1:1990 BS 6902-1 Supplement No. 1:1996

Scope

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.

BS EN 45502-2-1:2004 history

• 2004 BS EN 45502-2-1:2004 Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
• 2003 BS EN 45502-2-1:2003 Active implantable medical devices - Part 2-1:Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
• 1996 BS 6902-1 Supplement No. 1:1996 Cardiac pacemakers - Specification for implantable cardiac pacemakers - Electromagnetic compatibility
• 0000 BS 6902-1:1990