ANSI/AAMI/IEC 60601-2-2:2017
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
Hardcopy , PDF
English
30-06-2017
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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 |
84
|
| 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 61000-4-6:2013 | 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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