CSA C22.2 No. 601.2.31 : 1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
01-11-2009
French
01-01-2002
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Superseded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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