BS EN 45502-2-1:2003

Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 Measurement of implantable pulse generator and lead
   characteristics
7 General arrangement of the packaging
8 General markings for active implantable medical devices
9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile pack
12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects being caused by
   the active implantable medical device
15 Protection from harm to the patient or user caused by external
   physical features of the active implantable medical device
16 Protection from harm to the patient caused by electricity
17 Protection from harm to the patient caused by heat
18 Protection from ionizing radiation released or emitted from
   the active implantable medical device
19 Protection from unintended effects caused by the device
20 Protection of the device from damage caused by external
   defibrillators
21 Protection of the device from changes caused by high power
   electrical fields applied directly to the patient
22 Protection of the active implantable medical device from
   changes caused by miscellaneous medical treatments
23 Protection of the active implantable medical device from
   mechanical forces
24 Protection of the active implantable medical device from
   damage caused by electrostatic discharge
25 Protection of the active implantable medical device from
   damage caused by atmospheric pressure changes
26 Protection of the active implantable medical device from
   damage caused by temperature changes
27 Protection of the active implantable medical device from
   electromagnetic non-ionizing radiation
28 Accompanying documentation
Annex AA (informative) Table of cross-references from 90/385/EEC
         to EN 45502-2-1
Annex BB (informative) Relationship between the clauses of
         EN 45502 2-1 and the essential requirements of 90/385/EEC
         listed in Annex AA
Annex CC (informative) Notes on EN 45502-2-1
Annex DD (informative) Code for describing modes of implantable
         pulse generators
Annex EE (informative) Symbols
Annex FF (normative) Pulse forms
Annex GG (normative) Interface circuits
Annex HH (informative) Selection of capacitor C[x]
Annex II (normative) Calibration of the injection network, Figure GG.104
Figures
Tables

Specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.

This Part2-1 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias. The tests that are specified in EN45502 are type tests, and are to be carried out on samples of a device to show compliance. This Part2-1 is also applicable to some non-implantable parts and accessories of the devices (see Note1). The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this Part2-1 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 Part2-1 shall apply. Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by EN45502-2-2. NOTE1 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. NOTE2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE3 In this European Standard, terms printed in small capital letters are used as defined in Clause3. 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.