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ANSI/AAMI/IEC 60601-2-2:2017

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2017

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
 IEC 60601-2-2:2017
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 of 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
        for ME EQUIPMENT
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 DISTURBANCES - Requirements
        and tests
202.2 Normative references
202.3 Terms and definitions
202.7 Electromagnetic emissions requirements for
        ME EQUIPMENT and ME SYSTEMS
202.8 Electromagnetic IMMUNITY requirements for ME
        EQUIPMENT and ME SYSTEMS
202.101 Index of defined terms
208 General requirements, tests and guidance for
        alarm systems in medical electrical equipment
        and medical electrical systems
Annexes
Annex AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - ELECTROMAGNETIC DISTURBANCES
         created by HF SURGICAL EQUIPMENT
Bibliography
Index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENTand HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.

DevelopmentNote
Supersedes AAMI HF18. (01/2007)
DocumentType
Standard
ISBN
978-1-57020-664-1
Pages
86
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
IEC 60601-2-2:2017 Identical

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 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
CENELEC GUIDE 29 : 2007 TEMPERATURES OF HOT SURFACES LIKELY TO BE TOUCHED GUIDANCE DOCUMENT FOR TECHNICAL COMMITTEES AND MANUFACTURERS
IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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
AAMI HF18 : 2001 ERRATA 2001 ELECTROSURGICAL DEVICES
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

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