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CSA C22.2 No. 80601-2-35 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
Available format(s)

Hardcopy , PDF

Superseded date

06-19-2020

Language(s)

English - French

Published date

01-01-2016

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
       and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
       ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
208 General requirements, tests and guidance for ALARM
    SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
    ELECTRICAL SYSTEMS
210 Requirements for the development of physiologic
    closed-loop controllers
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Determination of the LAGGING MATERIAL
Annex CC (normative) - Determination of heat transfer towards
         the PATIENT
Annex DD (normative) - Determination of heat transfer away
         from the PATIENT
Annex EE (normative) - Conditions of adequate heat discharge
Annex FF (normative) - Test procedure for maximum CONTACT SURFACE
         TEMPERATURE for FORCED AIR DEVICES
Annex GG (normative) - Test procedure for maximum CONTACT SURFACE
         TEMPERATURE for FORCED AIR DEVICES under SINGLE FAULT
         CONDITION
Annex HH (normative) - Safety test procedure for average CONTACT
         SURFACE TEMPERATURE for FORCED AIR DEVICES
Bibliography
Index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT.

DevelopmentNote
NEW CHILD AMD 1 2020 IS ADDED
DocumentType
Standard
Pages
337
ProductNote
Reconfirmed EN NEW CHILD AMD 1 2020 IS ADDED
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

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IEC 60335-2-53:2011+AMD1:2017 CSV Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances and infrared cabins
ISO 2439:2008 Flexible cellular polymeric materials Determination of hardness (indentation technique)
CSA C22.2 No. 60601-1-10:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
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