I.S. EN 60601-2-54:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
13-06-2019
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
Applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY.
| DevelopmentNote |
Supersedes I.S. EN 60601-2-7 and I.S. EN 60601-2-32. (10/2009) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
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| DocumentType |
Standard
|
| Pages |
178
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-54:2009+AMD1:2015 CSV | Identical |
| IEC 60601-2-54:2009 | Equivalent |
| EN 60601-2-54:2009 | Equivalent |
| BS EN 60601-2-54:2009 | Equivalent |
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