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CSA C22.2 No. 601.2.31 : 1998

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE

Available format(s)

Hardcopy , PDF

Superseded date

11-01-2009

Language(s)

French

Published date

01-01-2002

FOREWORD
INTRODUCTION
SECTION ONE : GENERAL
1 Scope and object
2 Terminology
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO : ENVIRONMENTAL CONDITIONS
SECTION THREE : PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
14 Requirements related to classification
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
SECTION FOUR : PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE : PROTECTION AGAINST HAZARDS FROM
               UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION SIX : PROTECTION AGAINST HAZARDS OF IGNITION
              OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN : PROTECTION AGAINST EXCESSIVE TEMPERATURES
              AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization and disinfection
49 Interruption of power supply
SECTION EIGHT : ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
50 Accuracy of operation data
51 Protection against hazardous output
SECTION NINE : ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
SECTION TEN : CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
Figures
101 Measuring circuit for the MAXIMUM TRACKING RATE
101 Initial oscilloscope display when measuring MAXIMUM TRACKING RATE
Appendix/Annexes
Appendix L References - Publications mentioned in this Standard
Annexe AA General guidance and rationale
Annexe BB Bibliography

Gives safety requirements for internal electrical powered external pacemakers.

DevelopmentNote
Amendment 1 is available separately, see CSA C22.2.601.2.31A. (05/2004)
DocumentType
Standard
Pages
74
PublisherName
Canadian Standards Association
Status
Superseded
Supersedes

Standards Relationship
IEC 60601-2-31:2008+AMD1:2011 CSV Identical

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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
IEC 60086-2:2015 Primary batteries - Part 2: Physical and electrical specifications
IEC 60086-1:2015 Primary batteries - Part 1: General
ISO 5841-1:1989 Cardiac pacemakers Part 1: Implantable pacemakers
IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements

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