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ÖVE/ÖNORM EN 80601-2-58:2015-12

Заменен
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) (english version)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

IEC 60601-2-2:2006 ed4.0
Заменен
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment — 167 стр.
IEC 60601-2-22:2007 ed3.0
Заменен
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment — 52 стр.
ISO 11607-1:2006
Действует
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems — 32 стр.
ISO 11607-2:2006
Действует
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes — 18 стр.
ISO 17664:2004
Заменен
Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices — 26 стр.
BS EN 60601-1-2:2007
Действует
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests — 128 стр.
BS EN 60601-2-2:2009
Действует
Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories — 84 стр.
BS EN 60601-2-22:2013
Действует
Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment — 30 стр.
ÖNORM EN ISO 11607-1:2009-12
Заменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
ÖNORM EN ISO 11607-2:2006-07
Заменен
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
ÖNORM EN ISO 17664:2004-06
Заменен
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
ÖVE/ÖNORM EN 80601-2-58:2009-12
Заменен
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 80601-2-58:2008) (english version)

На этот документ ссылаются

ÖVE/ÖNORM EN 80601-2-58:2009-12
Заменен
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 80601-2-58:2008) (english version)