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СтандартыBSI

17/30357741 DC

Действует
BS ISO 11040-6. Prefilled syringes. Part 6. Plastic barrels for injectables and sterilized subassembled syringes ready for filling — 63 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 13485:2016
Действует
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.
ISO 11135-1:2007
Заменен
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — 48 стр.
ISO 13926-2:2011
Заменен
Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use — 14 стр.
ISO/IEC Guide 98-3:2008/Suppl.2:2011
Действует
Uncertainty of measurement -- Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) -- Supplement 2: Extension to any number of output quantities — 84 стр.
ISO 11040-7:2015
Действует
Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling — 34 стр.
ISO 11137-1:2006
Действует
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices — 44 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ISO 80369-7:2016
Действует
Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications — 52 стр.
ISO 9626:2016
Действует
Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods — 30 стр.
ISO 11040-5:2012
Действует
Prefilled syringes -- Part 5: Plunger stoppers for injectables — 10 стр.
ISO 7886-1:1993
Заменен
Sterile hypodermic syringes for single use; part 1: syringes for manual use — 32 стр.
ISO 80369-1:2010
Заменен
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements — 24 стр.
ISO 10993-7:2008
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals — 94 стр.
ISO 80369-20:2015
Действует
Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods — 36 стр.
ISO 7864:2016
Действует
Sterile hypodermic needles for single use -- Requirements and test methods — 32 стр.