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CSA C22.2 No. 60601.1.1 : 2002

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
Withdrawn date

26-08-2016

Published date

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)
DocumentType
Standard
PublisherName
Canadian Standards Association
Status
Withdrawn
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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