BS EN 45502-1:2015
Current
The latest, up-to-date edition.
Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer
Hardcopy , PDF
English
30-06-2015
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.
Committee |
CH/150/2
|
DevelopmentNote |
Supersedes 93/505778 DC. (09/2005) Supersedes 13/30233325 DC. (06/2015)
|
DocumentType |
Standard
|
Pages |
64
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
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.
Standards | Relationship |
I.S. EN 45502-1:2015 | Identical |
EN 45502-1 : 2015 | Identical |
NBN EN 45502-1 : 2015 | Identical |
NF EN 45502-1 : 1998 | Identical |
NS EN 45502-1 : 1997 | Identical |
NEN EN 45502-1 : 2015 | Identical |
SN EN 45502-1 : 1997 | Identical |
DIN EN 45502-1 : 2016 | Identical |
UNE-EN 45502-1:1998 | Identical |
EN 45502-1:2015 | Identical |
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EN 60068-2-47:2005 | Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests |
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