I.S. EN 60601-2-2:2009
Withdrawn
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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 (IEC 60601-2-2:2009 (EQV))
Hardcopy , PDF
English
01-01-2009
18-05-2021
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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 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
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
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - ELECTROMAGNETIC DISTURBANCES
created by HF SURGICAL EQUIPMENT
Bibliography
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements of
EC Directives
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT as defined in 201.3.222.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
91
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-2:2017 | Identical |
| BS EN 60601-2-2 : 2009 | Identical |
| DIN EN 60601-2-2 : 2010 | Identical |
| EN 60601-2-2:2009 | Identical |
| NF EN 60601-2-2 : 2009 AMD 11 2012 | Identical |
| IEC 60601-2-2:2009 | Equivalent |
| UNE-EN 60601-2-2:2010 | Identical |
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