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PD CEN ISO/TR 14969:2005

Действует
Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 — 88 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

BS EN 980:2003
Заменен
Graphical symbols for use in the labelling of medical devices — 28 стр.
ISO 19011:2002
Действует
Guidelines for quality and/or environmental management systems auditing — 31 стр.
ISO 14644-8:2013
Действует
Cleanrooms and associated controlled environments -- Part 8: Classification of air cleanliness by chemical concentration (ACC) — 30 стр.
ISO 14644-7:2004
Действует
Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) — 60 стр.
ISO 14644-6:2007
Действует
Cleanrooms and associated controlled environments -- Part 6: Vocabulary — 44 стр.
ISO 14644-5:2004
Действует
Cleanrooms and associated controlled environments -- Part 5: Operations — 52 стр.
ISO 14644-4:2001
Действует
Cleanrooms and associated controlled environments. Part 4. Design, construction and start-up — 58 стр.
ISO 14644-3:2005
Действует
Cleanrooms and associated controlled environments -- Part 3: Test methods — 72 стр.
ISO 14644-2:2000
Заменен
Cleanrooms and associated controlled environments. Part 2. Specification for testing and monitoring to prove continued compliance with ISO 14644-1 — 14 стр.
ISO 14644-1:1999
Заменен
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness — 24 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.

На этот документ ссылаются

DIN EN ISO 25539-2:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); German version EN ISO 25539-2:2009 — 124 стр.
DIN EN ISO 25539-3:2012-03
Действует
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011); German version EN ISO 25539-3:2011 — 112 стр.
DIN EN ISO 13485:2010-01
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009 — 75 стр.
DIN EN ISO 13485:2007-10
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007 — 75 стр.
DIN EN ISO 13408-1:2015-12
Действует
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015 — 70 стр.
DIN EN ISO 13408-1:2011-09
Отменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version EN ISO 13408-1:2011 — 65 стр.
DIN EN ISO 13408-1:2011-01
Отменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version FprEN ISO 13408-1:2010 — 65 стр.