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CEI EN IEC 80601-2-58:2025

Current

Current

The latest, up-to-date edition.

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

Language(s)

English

Published date

01-01-2025

€105.84
Excluding VAT

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

Committee
TC 62
DocumentType
Standard
ISBN
978-2-8322-8132-1
Pages
50
PublisherName
Comitato Elettrotecnico Italiano
Status
Current
Supersedes

Standards Relationship
IEC 80601-2-58:2024 Identical
EN IEC 80601-2-58:2024 Identical

IEC 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-9:2007 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10:2007 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

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€105.84
Excluding VAT