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EN 45502-2-2 : 2008 COR 2009

Current
Current

The latest, up-to-date edition.

ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
Published date

04-30-2009

1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 Measurement of IMPLANTABLE PULSE GENERATOR and LEAD
   characteristics
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 unintended 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
   changes caused by temperature changes
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   electromagnetic nonionizing radiation
28 Accompanying documentation
Annex AA (informative) - Table of cross-references from
         90/385/EEC to EN 45502-2-2
Annex BB (informative) - Relationship between the subclauses
         of EN 45502-2-2 and the essential requirements
         of 90/385/EEC listed in Annex AA
Annex CC (informative) - Notes on EN 45502-2-2
Annex DD (informative) - Code for describing modes of
         IMPLANTABLE PULSE GENERATORS
Annex EE (normative) - Interface circuits
Annex FF (informative) - Selection of capacitor C[x]
Annex GG (normative) Calibration of injection network
         Test signal of inhibition generator
Annex HH (informative) - Defined terms
Bibliography

This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.

Committee
JWG AIMD
DevelopmentNote
Together with EN 45502-2-1, it supersedes EN 50061. (11/2008) Supersedes PREN 45502-2-2. (05/2009)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current
Supersedes

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
ISO 14117:2012 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
NF EN 45502-2-1 : 2004 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
17/30359914 DC : 0 BS EN 50527-2-2 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
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
I.S. EN 45502-2-1:2004 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
AAMI ISO 27186 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
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
EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
08/30191626 DC : DRAFT OCT 2008 BS ISO 27186 - ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
10/30195946 DC : DRAFT DEC 2010 BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
BS ISO 27186:2010 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
PREN 50527-2-2 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
BS EN 45502-2-1:2003 Active implantable medical devices Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 50527-2-2:2018 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)
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
BS ISO 14117:2012 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 27186:2010 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
10/30208719 DC : 0
AAMI ISO 14117 : 2012 ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES
AAMI ISO 27185 : 2012 CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
ANSI/AAMI/ISO 14708-1:2014 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ISO 27185:2012 Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
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)
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
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
BS ISO 27185:2012 Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements

AAMI PC69 : 2007
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
EN 60068-2-27:2009 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
IEC 60068-2-47:2005 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
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
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 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 11318:2002 Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
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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