I.S. EN 45502-2-1:2004
Current
The latest, up-to-date edition.
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
Hardcopy , PDF
English
06-02-2004
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Introduction
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 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 temperature changes
27 Protection of the active implantable medical device from
electromagnetic non-ionizing radiation
28 Accompanying documentation
Annex AA (informative) Table of cross-references from
90/385/EEC to EN 45502-2-1
Annex BB (informative) Relationship between the clauses of
EN 45502 2-1 and the essential requirements of
90/385/EEC listed in Annex AA
Annex CC (informative) Notes on EN 45502-2-1
Annex DD (informative) Code for describing modes of implantable
pulse generators
Annex EE (informative) Symbols
Annex FF (normative) Pulse forms
Annex GG (normative) Interface circuits
Annex HH (informative) Selection of capacitor C[x]
Annex II (normative) Calibration of the injection network,
Figure GG/104
Figures
Tables
Specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.
| DevelopmentNote |
Partially Supersedes 1991 edition of I.S. EN 50061. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
97
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| NEN EN 45502-2-1 : 2004 | Identical |
| NS EN 45502-2-1 : 1ED 2004 | Identical |
| UNE-EN 45502-2-1:2005 | Identical |
| NF EN 45502-2-1 : 2004 | Identical |
| SN EN 45502-2-1 : 2003 | Identical |
| BS EN 45502-2-1:2003 | Identical |
| DIN EN 45502-2-1 : 2004-08 | Identical |
| AAMI PC69 : 2007 | |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| EN 45502-2-2 : 2008 COR 2009 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS) |
| 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 |
| 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 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 |
| ISO 11318:2002 | Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
| EN 45502-2-2 : 2008 COR 2009 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS) |
| 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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