Стандарты BSI

BS EN ISO 7864:2016

Действует

Sterile hypodermic needles for single use. Requirements and test methods — 36 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 80369-20:2015

Действует

Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods — 36 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/TR 19244:2014

Действует

Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and catheters — 10 стр.

ISO 8871-2:2003

Действует

Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization — 28 стр.

ISO 8537:2007

Заменен

Sterile singleuse syringes, with or without needle, for insulin — 30 стр.

ISO 8362-7:2006

Действует

Injection containers and accessories -- Part 7: Injection caps made of aluminiumplastics combinations without overlapping plastics part — 10 стр.

ISO 8362-6:2010

Действует

Injection containers and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials — 8 стр.

ISO 8362-5:2008

Заменен

Injection containers and accessories -- Part 5: Freeze drying closures for injection vials — 16 стр.

ISO 8362-4:2011

Действует

Injection containers and accessories -- Part 4: Injection vials made of moulded glass — 12 стр.

ISO 8362-3:2001

Действует

Injection containers and accessories. Part 3. Aluminium caps for injection vials — 10 стр.

ISO 8362-2:2008

Заменен

Injection containers and accessories -- Part 2: Closures for injection vials — 10 стр.

ISO 8362-1:2009/Amd.1:2015

Действует

Injection containers and accessories -- Part 1: Injection vials made of glass tubing -- Amendment 1 — 8 стр.

BS ISO 7000:2004

Действует

Graphical symbols for use on equipment. Index and synopsis — 212 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.

ISO 80369-1:2010

Заменен

Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements — 24 стр.

ISO 23908:2011

Действует

Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling — 18 стр.

ISO 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO 10993-11:2006

Заменен

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.

ISO 9626:2016

Действует

Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods — 30 стр.

BS ISO 8601:2004

Действует

Data elements and interchange formats. Information interchange. Representation of dates and times — 42 стр.

ISO 6009:1992

Заменен

Hypodermic needles for single use -- Colour coding for identification — 16 стр.

ISO 3696:1987

Действует

Water for analytical laboratory use; Specification and test methods — 8 стр.

ISO 594-2:1998

Заменен

Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings — 16 стр.

ISO 594-1:1986

Заменен

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements — 12 стр.

BS EN ISO 7864:1996

Действует

Sterile hypodermic needles for single use — 24 стр.

На этот документ ссылаются

BS EN 60601-2-24:2015

Действует

Medical electrical equipment. Particular requirements for the basic safety and essential performance of infusion pumps and controllers — 66 стр.

BS EN ISO 7886-2:1997

Действует

Sterile hypodermic syringes for single use. Syringes for use with power-driven syringe pumps — 32 стр.

BS EN ISO 1135-3:2017

Действует

Transfusion equipment for medical use. Blood-taking sets for single use — 24 стр.

BS EN 13976-2:2018

Действует

Rescue systems. Transportation of incubators. System requirements — 14 стр.

BS EN 13976-2:2011

Действует

Rescue systems. Transportation of incubators. System requirements — 14 стр.

BS EN ISO 8637-2:2018

Действует

Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters — 22 стр.