Technical Committee on Environmental Products
Technical Committee on Medical Electrical Equipment
Subcommittee on Cardiac Defibrillators
CSA Preface
CSA Foreword
Glossary of Equivalent Terms
Reference Publications
Canadian Deviations
IEC Standard 601-2-4 (1983)
Foreword
Preface
SECTION ONE - GENERAL
1 Scope and Object
2 Terminology and Definitions
3 General Requirements
4 General Requirements for Tests
5 Classification
6 Identification, Marking and Documents
7 Power Input
SECTION TWO - SAFETY REQUIREMENTS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
14 Requirements Related to Classification
17 Insulation and PROTECTIVE IMPEDANCES
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
CURRENTS
20 Dielectric Strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF EXPLOSIONS
IN MEDICALLY USED ROOMS
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES,
FIRE AND OTHER HAZARDS, SUCH AS HUMAN
ERRORS
42 Excessive Temperatures
44 Overflow, Spillage, Leakage, Humidity, Ingress of
Liquids, Cleaning, Sterilization and Disinfection
46 Human Errors
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST INCORRECT OUTPUT
50 Accuracy of Operating Data
51 protection Against Incorrect Output
SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR
MECHANICAL DAMAGE; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and General Assembly
57 MAINS PARTS, Components and Layout
SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY
101 Charging Time
102 INTERNAL ELECTRICAL POWER SOURCE
103 Endurance
104 SYNCHRONIZER
105 Recovery of the CARDIAC MONITOR after Defibrillation
106 Disturbance of the CARDIAC MONITOR from Charging or
Internal Discharging
Figures 101 to 109
APPENDIX B - Testing During Manufacturing and/or
Installation
APPENDIX AA - Rationale