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

Amended by

NF EN 80601-2-58/A1:2019

Available format(s)

Hardcopy

Language(s)

French, English - French

Published date

09-01-2015

Publisher

Association Francaise de Normalisation

Committee	SC 62D
DevelopmentNote	Indice de classement: C74-395. PR NF EN 80601-2-58 January 2008. (01/2008) PR NF EN 80601-2-58 June 2013. (07/2013) 2009 version along with its amendment is still active. (09/2015)
DocumentType	Standard
Pages	32
ProductNote	New child AMD 1 2019 is added
PublisherName	Association Francaise de Normalisation
Status	Current

Standards	Relationship
EN 80601-2-58:2015	Identical
IEC 80601-2-58:2014	Identical

NF EN 61847 : 2006	ULTRASONICS - SURGICAL SYSTEMS - MEASUREMENT AND DECLARATION OF THE BASIC OUTPUT CHARACTERISTICS
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
IEC 61847:1998	Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
NF EN 60601-1-2 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
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 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
NF EN 60601-2-2 : 2009 AMD 11 2012	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