I.S. EN IEC 60601-2-35:2021
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The latest, up-to-date edition.
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 60601-2-35:2020)
Hardcopy , PDF
English
02-08-2021
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NTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
10 Protection against unwanted and excessive radiation HAZARDS
11 Protection against excessive temperatures and other HAZARDS
12 Accuracy of controls and instruments and protection against hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 ELECTROMAGNETIC DISTURBANCES – 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
Annexes
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
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