CSA C22.2 No. 80601-2-35 : 2012(R2016)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
Hardcopy , PDF
25-09-2021
English - French
01-06-2020
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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
Index of defined terms used in this particular standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT.
| DocumentType |
Standard
|
| ISBN |
978-1-4883-3144-2
|
| Pages |
173
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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 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 |
| IEC 60335-2-53:2011+AMD1:2017 CSV | Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances and infrared cabins |
| ISO 2439:2008 | Flexible cellular polymeric materials Determination of hardness (indentation technique) |
| CSA C22.2 No. 60601-1-10:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 3743-1:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for small movable sources in reverberant fields Part 1: Comparison method for a hard-walled test room |
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