CSA C22.2 No. 601.2.31 : 1998
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
Hardcopy , PDF
01-11-2009
French
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 |
Withdrawn
|
| 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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