CSA C22.2 No. 80601-2-58 : 2010

Superseded

MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY

Available format(s)

Hardcopy , PDF

Superseded date

28-07-2021

Language(s)

English

Published date

01-01-2015

Publisher

Canadian Standards Association

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 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 compatibility Requirements and
       tests
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

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.

DocumentType	Standard
Pages	78
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA C22.2 No. 80601-2-58 : 2015

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
C22.1-15	Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
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
ISO 15004-2:2007	Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
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