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ANSI/AAMI/IEC 80601-2-58:2014

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-10-2014

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

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

Committee
SC 62D
DocumentType
Standard
ISBN
1-57020-562-0
Pages
53
ProductNote
NEW CHILD AMD 1 2016 IS NOW ADDED
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
IEC 80601-2-58:2014+AMD1:2016 CSV Identical

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 15752:2010 Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
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
IEC 60601-2-2:2017 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
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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