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BS EN 45502-1:2015

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-06-2015

€303.84
Excluding VAT

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

BS 7373-2:2001 Product specifications Guide to identifying criteria for a product specification and to declaring product conformity

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IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
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ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
AAMI TIR42 : 2010 EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
EN 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
EN 62127-1:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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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