EN 45502-2-2 : 2008 COR 2009

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 unintended 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
   changes caused by temperature changes
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   electromagnetic nonionizing radiation
28 Accompanying documentation
Annex AA (informative) - Table of cross-references from
         90/385/EEC to EN 45502-2-2
Annex BB (informative) - Relationship between the subclauses
         of EN 45502-2-2 and the essential requirements
         of 90/385/EEC listed in Annex AA
Annex CC (informative) - Notes on EN 45502-2-2
Annex DD (informative) - Code for describing modes of
         IMPLANTABLE PULSE GENERATORS
Annex EE (normative) - Interface circuits
Annex FF (informative) - Selection of capacitor C[x]
Annex GG (normative) Calibration of injection network
         Test signal of inhibition generator
Annex HH (informative) - Defined terms
Bibliography

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.