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CSA C22.2 No. 601.1.1 : 2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
Available format(s)

Hardcopy , PDF

Superseded date

01-04-2002

Language(s)

English

Published date

01-01-2000

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
Figure 201 Example of PATIENT ENVIRONMENT
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, as defined in 2.201. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.

DevelopmentNote
Also numbered as IEC 60601-1-1. (08/2002)
DocumentType
Standard
Pages
72
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

CSA C22.2 No. 601.2.13 : 0 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC MACHINES

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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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