I.S. EN 80601-2-35:2009&A11:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
11-03-2022
20-10-2011
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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