BS EN 60601-2-2 : 2009
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
01-01-2009
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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.
| Committee |
CH/62/4
|
| DevelopmentNote |
Renumbers and supersedes BS 5724-2.2(1992). 1993 version incorporates amendment 7868 to BS 5724-2.2(1992). Supersedes BS 5724-2.2(1983), 88/54010 DC & 97/561001 DC. (01/2006) Supersedes 04/30094882 DC. (05/2007) To be read in conjunction with BS EN 60601-1. Supersedes 06/30154544 DC. (08/2009) 2009 Edition Re-issued in March 2012 & incorporates AMD 11 2011. 2009 Edition remains current. (03/2012)
|
| DocumentType |
Standard
|
| Pages |
84
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNE-EN 60601-2-2:2010 | Identical |
| IEC 60601-2-2:2017 | Identical |
| SN EN 60601-2-2 : 2009 AMD 11 2011 | Identical |
| NF EN 60601-2-2 : 2009 AMD 11 2012 | Identical |
| I.S. EN 60601-2-2:2009 | Identical |
| EN 60601-2-2:2009 | Identical |
| DIN EN 60601-2-2 : 2010 | Identical |
| EN 60601-2-18:2015 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 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 |
| EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| 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 |
| EN 60601-1-2:2015 | 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 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 |
| EN 61000-4-6:2014/AC:2015 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013) |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
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