MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)

Amendment of

EN 80601-2-35:2009

Superseded date

06-09-2021

Superseded by

EN IEC 60601-2-35:2021

Published date

16-06-2017

Publisher

European Committee for Standards - Electrical

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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
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements of
         EC Directives

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

Committee	TC 62
DevelopmentNote	Supersedes EN 60601-2-35. (01/2010)
DocumentType	Draft
PublisherName	European Committee for Standards - Electrical
Status	Superseded
SupersededBy	EN IEC 60601-2-35:2021
Supersedes	EN 80601-2-35:2009/AC:2015 EN 60601-2-35:1996

Standards	Relationship
SN EN 80601-2-35:2009+A11:2011+AC:2015+A1:2016	Identical
DIN EN 80601-2-35 : 2017	Identical
NEN EN IEC 80601-2-35 : 2010 AMD 1 2016	Identical
I.S. EN 80601-2-35:2009	Identical
CEI EN 80601-2-35 : 2011/A1 : 2018	Identical
NF EN 80601-2-35 : 2010 AMD 1 2017	Identical
PN EN 80601-2-35 : 2010 AMD 1 2017	Identical
NBN EN 80601-2-35 : 2010 COR 2015	Identical
BS EN 80601-2-35 : 2009	Identical
UNE-EN 80601-2-35:2010	Identical
I.S. EN 80601-2-35:2009/A1:2016	Identical
UNE-EN 80601-2-35:2010/A1:2016	Identical
PNE-EN 80601-2-35:2009/FprA1	Identical
VDE 0750-2-35 : 2017	Identical
ONORM OVE EN 80601-2-35 : 2017	Identical

BS EN 60601-2-20 : 2009	MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
UNE-EN 60601-2-20:2010	Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
DIN EN 12182:2012-07	Assistive products for persons with disability - General requirements and test methods
I.S. EN 12182:2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN 12182 : 2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
BS EN 12182:2012	Assistive products for persons with disability. General requirements and test methods
EN 60601-2-20:2009/A1:2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016)
EN 12182:2012	Assistive products for persons with disability - General requirements and test methods

EN 60601-2-20:2009/A1:2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016)
IEC 60601-2-21:2009+AMD1:2016 CSV	Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-19:2009+AMD1:2016 CSV	Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-1-10:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
EN 60601-2-19:2009/A1:2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016)
IEC 60601-2-20:2009+AMD1:2016 CSV	Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
EN 60601-1-10:2008/A1:2015	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 (IEC 60601-1-10:2007)
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60335-2-53:2011	Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances and infrared cabins
EN 60601-2-21:2009/A1:2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016)
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)
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN ISO 2439:2008	Flexible cellular polymeric materials - Determination of hardness (indentation technique) (ISO 2439:2008)
EN 60601-1-8:2007/A11:2017	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)

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EN 80601-2-35:2009/A1:2016

MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory