IEC 60601-2-35:1996
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical electrical equipment - Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
09-26-2020
English - French, Spanish, Castilian
11-06-1996
FOREWORD
INTRODUCTION
Clause
SECTION ONE - GENERAL
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
Appendix/Annexes
L References - Publications mentioned in this standard
AA Rationale to particular subclauses
BB Determination of the lagging material
CC 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 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 CONDITIONS OF ADEQUATE HEAT DISCHARGE
Establishes requirements, which minimize hazards to patient andoperator, for heating devices such as blankets, pads, mattresses andfluid-filled mattresses. Specifies tests by which comliance canbe verified.
Committee |
TC 62/SC 62D
|
DevelopmentNote |
Also numbered as BS EN 60601-2.35 & BS 5724-2.35(1997). (11/2005)
|
DocumentType |
Standard
|
Pages |
95
|
PublisherName |
International Electrotechnical Committee
|
Status |
Withdrawn
|
SupersededBy |
Standards | Relationship |
NBR IEC 60601-2-35 : 2006 | Identical |
NEN 10601-2-35 : 1997 | Identical |
I.S. EN 60601-2-35:1998 | Identical |
PN EN 60601-2-35 : 2006 | Identical |
SN EN 60601-2-35 : 1996 | Identical |
AS/NZS 3200.2.35:1999 | Identical |
UNE-EN 60601-2-35:1997 | Identical |
CEI EN 60601-2-35 : 1999 | Identical |
EN 60601-2-35:1996 | Identical |
DIN EN 60601-2-35 : 1997 | Identical |
NF EN 60601 2-35 : 1997 | Identical |
BS ISO 17966:2016 | Assistive products for personal hygiene that support users. Requirements and test methods |
I.S. EN 61219:1994 | LIVE WORKING - EARTHING OR EARTHING AND SHORT-CIRCUITING EQUIPMENT USING LANCES AS A SHORT-CIRCUITING DEVICE - LANCE EARTHING |
EN 61219:1993 | Live working - Earthing or earthing and short-circuiting equipment using lances as short-circuiting device - Lance earthing |
13/30277861 DC : 0 | BS EN 60335-2-111 ED 1.0 - HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-111: PARTICULAR REQUIREMENTS FOR ELECTRIC ONDOL MATTRESS WITH A NON-FLEXIBLE HEATED PART |
I.S. EN 60601-2-50:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT |
I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
CEI EN 60335-2-17 : 2013 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2: PARTICULAR REQUIREMENTS FOR BLANKETS, PADS, CLOTHING AND SIMILAR FLEXIBLE HEATING APPLIANCES |
UNE-EN 60335-2-17:2013 | Household and similar electrical appliances - Safety - Part 2-17: Particular requirements for blankets, pads, clothing and similar flexible heating appliances |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
07/30164508 DC : 0 | IEC 60601-2-21 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
14/30257546 DC : 0 | BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS |
BS EN 60335-2-17:2013 | Household and similar electrical appliances. Safety Particular requirements for blankets, pads, clothing and similar flexible heating appliances |
I.S. EN 60335-2-17:2013 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-17: PARTICULAR REQUIREMENTS FOR BLANKETS, PADS, CLOTHING AND SIMILAR FLEXIBLE HEATING APPLIANCES (IEC 60335-2-17:2012 (EQV)) |
I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
ISO 17966:2016 | Assistive products for personal hygiene that support users Requirements and test methods |
EN 60335-2-17:2013 | Household and similar electrical appliances - Safety - Part 2-17: Particular requirements for blankets, pads, clothing and similar flexible heating appliances |
ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
IEC 60335-2-17:2012+AMD1:2015 CSV | Household and similar electrical appliances - Safety - Part 2-17:Particular requirements for blankets, pads, clothing and similar flexible heating appliances |
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