CSA C22.2 No. 60601.1.1 : 2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
26-08-2016
01-01-2011
FOREWORD
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids,
cleaning, sterilization, disinfection and compatibility
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Annex AAA (informative) - General guidance and rationale
Annex BBB (informative) - Examples of combinations of MEDICAL
ELECTRICAL EQUIPMENT and non-medical electrical
equipment
Annex CCC (normative) - Normative references
Annex DDD (informative) - Bibliography
Annex EEE (normative) - Requirements for MULTIPLE PORTABLE
SOCKET-OUTLETS
Annex FFF (informative) - Examples of application of MULTIPLE
PORTABLE SOCKET-OUTLETS
Pertains to the safety of MEDICAL ELECTRICAL SYSTEMS. Describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.
DevelopmentNote |
Supersedes CSA C22.2.601.1.1. (02/2006)
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DocumentType |
Standard
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PublisherName |
Canadian Standards Association
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Status |
Withdrawn
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SupersededBy | |
Supersedes |
Standards | Relationship |
IEC 60601-1-1:2000 | Identical |
CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
CSA C22.2 No. 60601.2.13 :2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
CSA Z364.2.1:2013 | MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT |
CSA C22.2 No. 60601.2.13 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
CSA Z386:2014(R2019) | SAFE USE OF LASERS IN HEALTH CARE |
Z364.2.1-13 (R2018) | Monitoring systems for hemodialysis equipment |
CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
C22.2 NO. 205-17 | Signal equipment |
CSA Z32 : 2015 | ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES |
IEC 60950:1999 | Safety of information technology equipment |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
ISO 8359:1996 | Oxygen concentrators for medical use Safety requirements |
ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
ISO 9918:1993 | Capnometers for use with humans Requirements |
ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
IEC 60989:1991 | Separating transformers, autotransformers, variable transformersand reactors. |
IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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