EN 45502-2-2 : 2008 COR 2009
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)
30-04-2009
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 |
| Standards | Relationship |
| UNE-EN 45502-2-2:2008 CORR:2009 | Identical |
| NS EN 45502-2-2 : 2008 | Identical |
| CEI UNI EN 45502-2-2 : 2019 | Identical |
| DIN EN 45502-2-2 : 2008 COR 1 2009 | Identical |
| BS EN 45502-2-2:2008 | Identical |
| PN EN 45502-2-2 : 2008 AC 2009 | Identical |
| NF EN 45502-2-2 : 2008 | Identical |
| UNE-EN 45502-2-2:2008 | Identical |
| NEN EN 45502-2-2 : 2008 C1 2009 | Identical |
| I.S. EN 45502-2-2:2008 | Identical |
| SN EN 45502-2-2 : 2008 CORR 2009 | Identical |
| NBN EN 45502-2-2 : 2009 | Identical |
| VDE 0750-10-2 : 2008 COR 1 2009 | Identical |
| 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 |
| 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 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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