ANSI/AAMI/IEC 80601-2-58:2014
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY
Hardcopy , PDF
English
10-09-2014
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of Amendment
1 to IEC 80601-2-58:2014
Foreword
Introduction to the Amendment
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 for
ME EQUIPMENT
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 disturbances - Requirements and tests
Annexes
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking (See Clause 7)
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms
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