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BS EN 60601-2-35:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use

Available format(s)

Hardcopy , PDF

Superseded date

03-31-2010

Language(s)

English

Published date

04-15-1997

INTRODUCTION
1 Scope and object
2 Terminology and definitions
3 General requirements
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
17 Separation
19 Continuous leakage currents and patient auxiliary
    currents
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization, disinfection and
    compatibility
46 Human errors
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
56 Components and general assembly
57 Mains parts, components and layout
59 Construction and layout
Figures
101aPositioning of temperature sensors on the contact
    surface of the heated area of a heating device
101bExample of the positioning of temperature sensors
    on the contact surface of the heated areas of a
    heating device having more than one separately heated
    area
102 Ramp for the impact test on pads
103 Partial covering conditions
104 Method of folding blankets
105 Examples of folds
106 Positions of a blanket for the ruck-resistance test
107aApparatus for the spark ignition test
107bDetails of an apparatus for the spark ignition test
108 Illustration of the main requirements of this
    Standard
Appendix/Annexes
L References - publications mentioned in this standard
AA (informative) Rationale to particular subclause
BB (normative) Determination of the lagging material
CC (normative) Procedure for determining whether a
    heating device provides high or low heat transfer
    from the heat source to the contact surface (i.e.
    towards the patient
DD (normative) Procedure for determining whether a heating
    device provides high or low heat transfer from the
    contact surface to the heat source (i.e. away from
    the patient)
EE (normative) Normative references to international
    publications with their corresponding European
    publications
ZB (informative) Normative references to international
    publications with their corresponding European
    publications

Defines requirements for blankets, pads and mattresses, includes air flotation mattresses and forced air systems. ALSO NUMBERED AS BS 5724 SECTION 2.35 1997

Committee
CH/62/4
DevelopmentNote
Also numbered as BS 5724-2.35(1997) & IEC 60601-2-35. Supersedes 92/57544 DC. (11/2005)
DocumentType
Standard
Pages
42
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 60601-2-35:1996 Identical
DIN EN 60601-2-35 : 1997 Identical
UNE-EN 60601-2-35:1997 Identical
SN EN 60601-2-35 : 1996 Identical
I.S. EN 60601-2-35:1998 Identical

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 60384-14:2013+AMD1:2016 CSV Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
ISO 3743-2:1994 Acoustics Determination of sound power levels of noise sources using sound pressure Engineering methods for small, movable sources in reverberant fields Part 2: Methods for special reverberation test rooms
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
BS 5724-1(1989) : 1989 AMD 6715 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY
BS EN 60601-1-1:2001 Medical electrical equipment. General requirements for safety Collateral standard. Safety requirements for medical electrical systems
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
BS EN 60601-2-21 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009)
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
IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
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
BS ISO 3743-2 : 1994 AMD 9426 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES USING SOUND PRESSURE - ENGINEERING METHODS FOR SMALL, MOVABLE SOURCES IN REVERBERANT FIELDS - METHODS FOR SPECIAL REVERBERATION TEST ROOMS
ISO 2439:2008 Flexible cellular polymeric materials Determination of hardness (indentation technique)
BS EN 60601-2-19 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009)
BS 6201-3:1982 Fixed capacitors for use in electronic equipment Specification for fixed capacitors for radio interference suppression. Selection of methods of test and general requirements
EN 61000-4-6:2014/AC:2015 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
BS EN 60601-1-2:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests

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