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I.S. EN 45502-2-2:2008

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)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2008

Preview

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.

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 Cx
Annex GG (normative) Calibration of injection network
         (Figure EE.105); Test signal of inhibition
         generator (Figure GG.101)
Annex HH (informative) Defined terms
Bibliography

Describes requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.

DevelopmentNote
Partially Supersedes 1991 edition of I.S. EN 50061. (07/2017)
DocumentType
Standard
Pages
106
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 45502-2-2 : 2008 COR 2009 Identical
EN 45502-2-2 : 2008 COR 2009 Identical

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
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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