BS EN 60601-2-45 : 2011
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
Hardcopy , PDF
English
01-01-2015
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
203 Radiation protection in diagnostic X-ray equipment
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
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 MAMMOGRAPHIC X-RAY EQUIPMENT 'including equipment for MAMMOGRAPHIC TOMOSYNTHESIS and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT.
| Committee |
CH/62/2
|
| DevelopmentNote |
Supersedes 99/565170 DC (12/2001) Supersedes 97/562760 DC. (03/2007) Supersedes BS 5724-2-45(2001) & 09/30170496 DC. To be read in conjunction with BS EN 60601-1 & BS EN 60601-1-3. (05/2011) Supersedes BS 5724-2.45(1999).(08/2015) 2011 Edition remains active & will be withdrawn on 23/07/2018. 2011 Edition Re-Issued in October 2015 & incorporates AMD 1 2015. Supersedes 13/30267930 DC (10/2015)
|
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-2-45:2011 | Identical |
| I.S. EN 60601-2-45:2011 | Identical |
| IEC 60601-2-45:2011+AMD1:2015 CSV | Identical |
| DIN EN 60601-2-45 : 2017-01 | Identical |
| UNE-EN 60601-2-45:2002 | Identical |
| UNE-EN 60601-2-45:2011 | Equivalent |
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