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Norm

OVE EN 80601-2-58

Ausgabedatum: 2020 07 01

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 (IEC 80601-2-58:2014 + A1:2016) (english version)

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 20...
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Herausgeber:
Österreichischer Verband für Elektrotechnik
Format:
Digital | 66 Seiten
Sprache:
Englisch
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.
OVE EN 80601-2-58
2020 07 01
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential...
Norm
ÖVE/ÖNORM EN 80601-2-58
2015 12 01
Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essenti...
Norm
ÖVE/ÖNORM EN 80601-2-58
2015 12 01
Medizinische elektrische Geräte -- Teil 2-58: Besondere Festlegungen für die Sicherheit einschließl...
Norm
ÖVE/ÖNORM EN 80601-2-58
2009 12 01
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential...
Norm
ÖVE/ÖNORM EN 80601-2-58
2009 12 01
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlic...
Norm
Historie aufklappen
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ISO 11607-1:2006
Ausgabedatum : 2006 04 07
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
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ISO 11607-2:2006
Ausgabedatum : 2006 04 07
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
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ISO 17664:2004
Ausgabedatum : 2004 02 25
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices