BS EN 60601-2-54:2009
Superseded
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
Hardcopy , PDF
English
01-01-2009
10-07-2019
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
Annexes
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this collateral 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 ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY.
| Committee |
CH/62/2
|
| DevelopmentNote |
To be read in conjunction with BS EN 60601-1. Supersedes BS EN 60601-2-7, BS 5724-2.7(1998), BS EN 60601-2-32, BS 5724-2.32(1995) & 08/30149952 DC. (04/2010) 2009 Edition along with it's corrigendum remains active & will be withdrawn on 22/05/2018. 2009 Edition Re-Issued in July 2015 & incorporates AMD 1 2015. Supersedes 14/30296597 DC. (08/2015)
|
| DocumentType |
Standard
|
| Pages |
76
|
| ProductNote |
Implementation of IEC amendment 2:2018 with NCENELEC endorsement A2:2019. Annex ZA amended
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-54:2009+AMD1:2015 CSV | Identical |
| EN 60601-2-54:2009 | Equivalent |
| I.S. EN 60601-2-54:2009 | Equivalent |
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