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EN 45502-2-3:2010

Current
Current

The latest, up-to-date edition.

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Published date

19-02-2010

Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 Inspection and measurement
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 device
20 Protection of the device from damage caused by external
   defibrillators
21 Protection of the device from changes caused by high
   power 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-ionising radiation
28 Accompanying documentation
Annex AA (informative) - Notes on EN 45502-2-3
Annex BB (informative) - Notes on theoretical modelling to
         demonstrate compliance to Clause 27
Annex CC (informative) - Notes on EMI measurements to demonstrate
         compliance to Clause 27
Bibliography

This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this European Standard.The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.This Part of EN 45502 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see NOTE 1).The electrical characteristics of the IMPLANTABLE PART shall be determined by either the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this particular standard shall apply.NOTE 1The device that is commonly referred to as an active implantable medical device can in fact 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 part.NOTE 2The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.NOTE 3In this European Standard, terms printed in small capital letters are used as defined in Clause 3. 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.

Committee
CEN/CLC/JTC 16
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

08/30191453 DC : DRAFT OCT 2008 BS EN 50527-1 - ASSESSMENT OF HUMAN EXPOSURE AT THE WORKPLACE FOR PERSONS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES (AIMD) IN ELECTRIC, MAGNETIC AND ELECTROMAGNETIC FIELDS WITH FREQUENCIES FROM 0 HZ TO 300 GHZ - PART 1: GENERAL
EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
PREN 50527-1 : DRAFT 2015 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
BS EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices General
I.S. EN 50527-1:2016 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
ISO 14708-7:2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
15/30321267 DC : DRAFT FEB 2015 BS EN 50527-1 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
UNE-EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General

AAMI PC69 : 2007
EN 60068-2-75:2014 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
MIL-STD-883 Revision K:2016 TEST METHOD STANDARD - MICROCIRCUITS
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
IEC 60118-6:1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
HD 323.2.17 : 200S4 BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - TEST Q: SEALING
EN 1593:1999/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - BUBBLE EMISSION TECHNIQUES
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
HD 323.2.33 : 200S1 BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - GUIDANCE ON CHANGE OF TEMPERATURE TESTS
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
ISO 5841-2:2014 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 60068-2-27:2009 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
EN 13185:2001/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - TRACER GAS METHOD
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
IEC 60068-2-17:1994 Basic environmental testing procedures - Part 2-17: Tests - Test Q: Sealing
EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60068-2-75:2014 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 60118-6:1999 Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements
EN 60801-2 : 1993 ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991)
EN 60068-2-31:2008 ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS
EN 60068-2-47:2005 Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
IEC 60068-2-56:1988 Environmental testing - Part 2: Tests. Test Cb: Damp heat, steady state, primarily for equipment

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