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BS EN ISO 14155:2011

Действует
Clinical investigation of medical devices for human subjects. Good clinical practice — 68 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 10993-4:2002/Amd.1:2006
Заменен
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.
ISO 15223-1:2012
Заменен
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 30 стр.
BS EN 1041:1998
Заменен
Information supplied by the manufacturer with medical devices — 20 стр.
BS EN ISO 14155-1:2009
Заменен
Clinical investigation of medical devices for human subjects. General requirements — 32 стр.
BS EN ISO 14155-2:2009
Заменен
Clinical investigation of medical devices for human subjects. Clinical investigation plans — 20 стр.

На этот документ ссылаются

BS EN ISO 14155-1:2009
Заменен
Clinical investigation of medical devices for human subjects. General requirements — 32 стр.
BS EN ISO 14155-2:2009
Заменен
Clinical investigation of medical devices for human subjects. Clinical investigation plans — 20 стр.
BS 70000:2017
Действует
Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence — 56 стр.
BS EN 50527-2-1:2016
Действует
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers — 72 стр.
BS EN ISO 7198:2017
Действует
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.
BIP 0113:2012
Действует
Guide to European medical device trials and BS EN ISO 14155 — 104 стр.
BS EN 12182:2012
Действует
Assistive products for persons with disability. General requirements and test methods — 66 стр.
PD CEN/TR 15640:2007
Действует
Health informatics. Measures for ensuring the patient safety of health software — 48 стр.
BS EN 50527-2-2:2018
Действует
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardioverter defibrillators (ICDs) — 64 стр.
BS EN ISO 14607:2018
Действует
Non-active surgical implants. Mammary implants. Particular requirements — 56 стр.