AAMI ISO 80601-2-35 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
15-06-2010
English
01-01-2009
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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.
| DevelopmentNote |
Issued by AAMI in January 2015. (01/2015)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-536-1
|
| Pages |
72
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| 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 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| 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 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| 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 |
| 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) |
| 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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