BS EN 60601-2-35:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use
Hardcopy , PDF
31-03-2010
English
15-04-1997
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 61000-4-6:2013 | 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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