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ÖNORM EN ISO 14155:2021-01

Действует
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ÖNORM EN ISO 14155:2012-02
Заменен
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor 1:2011)

На этот документ ссылаются

DIN EN ISO 20697:2019-04
Действует
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09); German version EN ISO 20697:2018 — 48 стр.
DIN EN ISO 20697:2018-10
Отменен
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018); German version EN ISO 20697:2018 — 47 стр.
DIN EN ISO 25539-2:2013-05
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012); German version EN ISO 25539-2:2012 — 115 стр.
DIN EN ISO 80601-2-55:2019-03
Действует
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018); German version EN ISO 80601-2-55:2018 — 79 стр.
DIN EN ISO 80601-2-55:2018-07
Отменен
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018); German version EN ISO 80601-2-55:2018 — 79 стр.
DIN EN ISO 81060-2:2014-10
Отменен
Non-invasive sphygmomanometers - Part 2: Clinical invastigation of automated measurement type (ISO 81060-2:2013); German version EN ISO 81060-2:2014 — 52 стр.
DIN EN ISO 80601-2-56:2018-02
Отменен
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017); German version EN ISO 80601-2-56:2017 — 74 стр.
DIN EN ISO 10079-1:2016-05
Отменен
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015); German version EN ISO 10079-1:2015 — 42 стр.
DIN EN ISO 8836:2015-02
Отменен
Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 — 42 стр.
ÖNORM EN ISO 14155:2012-02
Заменен
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor 1:2011)