Back

EVS-EN 80601-2-58:2009/A11:2011

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

General information
Withdrawn from 02.07.2015
Base Documents
EN 80601-2-58:2009/A11:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.07.2015
Main
02.11.2011
Amendment
03.04.2009
Main
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and  VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated  ACCESSORIES that can be connected to this  MEDICAL ELECTRICAL  EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of  ME EQUIPMENT or  ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
*
*
*
PDF
7.32 € incl tax
Paper
7.32 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
Withdrawn from 02.04.2018
Main

EVS-EN ISO 14155 V2:2011

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Withdrawn from 02.10.2020
Main + amendment

EVS-EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices
Withdrawn from 17.05.2021
Main

EVS-EN ISO 14630:2012

Non-active surgical implants - General requirements (ISO 14630:2012)
Newest version Valid from 04.01.2013