ÖNORM EN ISO 3826-4:2015-12

Действует

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

Описание Изменения Ссылки Версии

Ссылочные документы

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 1135-4:2015

Действует

Transfusion equipment for medical use -- Part 4: Transfusion sets for single use, gravity feed — 22 стр.

ISO 3696:1987

Действует

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

ISO 3826-1:2013

Действует

Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers — 30 стр.

ISO 3826-2:2008

Действует

Plastics collapsible containers for human blood and blood components -- Part 2: Graphical symbols for use on labels and instruction leaflets — 18 стр.

ISO 3826-3:2006

Действует

Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features — 14 стр.

ISO 8536-4:2010

Действует

Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed — 22 стр.

ISO 10993-1:2009/Cor.1:2010

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 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 10993-5:2009

Действует

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.

ISO 10993-10:2010

Действует

Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.

ISO 10993-11:2017

Действует

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 36 стр.

ISO 10993-12:2012

Действует

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 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 15747:2018

Действует

Plastic containers for intravenous injections — 22 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.