13/30233325 DC : 0

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations (optional)
5 General requirements for ACTIVE IMPLANTABLE
   MEDICAL DEVICES
6 Requirements for particular ACTIVE IMPLANTABLE
   MEDICAL DEVICES
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 ACTIVE
   IMPLANTABLE MEDICAL DEVICE
20 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from damage caused by external defibrillators
21 Protection of the ACTIVE IMPLANTABLE MEDICAL
   DEVICE from changes caused by 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 A (informative) - General guidance and rationale
Annex ZZ (informative) - Coverage of Essential Requirements
         of EU Directives
Bibliography

BS EN 45502-1