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NEN-EN-IEC 80601-2-58/A1

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

active, Most Current
Organization: NEN
Publication Date: 1 September 2019
Status: active
Page Count: 34
ICS Code (Ophthalmic equipment): 11.040.70

Document History

NEN-EN-IEC 80601-2-58/A1
September 1, 2019
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
A description is not available for this item.
NEN-EN-IEC 80601-2-58
July 1, 2015
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
NEN-EN-IEC 80601-2-58 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...
NEN-EN-IEC 80601-2-58/A11
November 1, 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
A description is not available for this item.
NEN-EN-IEC 80601-2-58
May 1, 2009
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
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...

References

This document references:
2000/70/EC - Directive of the European Parliment and of the Council Amending Council Directive 93/42/EEC as Regards Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma
Published by EU on November 16, 2000
A description is not available for this item.
This document references:
EEC/2001/104 - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 93/42/EEC concerning medical devices
Published by EEC on December 7, 2001
A description is not available for this item.
This document references:
EEC/2007/47 - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Published by EEC on September 5, 2007
A description is not available for this item.
This document references:
NO 1882/2003 - REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty
Published by EU on September 29, 2003
A description is not available for this item.
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