BS EN 45502-1:2015

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 ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 90/385/EEC on
         Active Implantable Medical Devices
Bibliography

Provides requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.

This part of EN45502 specifies requirements that are generally applicable to active implantable medical devices. NOTE1 For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN45502 are type tests and are to be carried out on samples of an active implantable medical device to show compliance. This part of EN45502 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This part of EN45502 is also applicable to some non-implantable parts and accessories of the active implantable medical devices. NOTE2 The device that is commonly referred to as an active implantable medical device can 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. NOTE3 In this part of EN45502, 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.