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I.S. EN 45502-1:2015

Current

Current

The latest, up-to-date edition.

IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

€88.00
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.

DocumentType
Standard
Pages
64
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
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
BS 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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IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
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EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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
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ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
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IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
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AAMI TIR42 : 2010 EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
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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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