BS EN 45502-2-1:2003 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.

The tests that are specified in BS EN 45502-2-1:2003 are type tests, and are to be carried out on samples of a device to show compliance.

BS EN 45502-2-1:2003 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.



Cross References:
EN 28601:1992
ISO 8601:1988
EN 45502-1:1997
EN 45502-2-2
EN 60068.2.27:1993
IEC 60068.2. 27:1987
EN 60068.2.47:1999
IEC 60068-2-47:1999
EN 60068.2.64:1994
IEC 60068-2-64:1993
ISO 5841-3:1992
ISO 11318:1993
ANSI/AAMI PC69-2000
90/385/EEC