CENELEC - EN 45502-2-2
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
|Publication Date:||1 March 2008|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.
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 of EN 45502 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 particular standard or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Particular Standard shall apply.
Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502-2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers).
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.
NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this standard.