18/30357483 DC

Действует

BS EN ISO 3826-1. Plastics collapsible containers for human blood and blood components. Part 1. Conventional containers — 33 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 10993-11:2006

Заменен

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

ISO 3696:1987

Действует

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

ISO 10993-1:2009

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.

ISO 1135-5:2015

Действует

Transfusion equipment for medical use -- Part 5: Transfusion sets for single use with pressure infusion apparatus — 26 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 10993-12:2012

Действует

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

ISO 10993-10:2010

Действует

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

ISO 1135-4:2012

Заменен

Transfusion equipment for medical use -- Part 4: Transfusion sets for single use — 20 стр.

ISO 10993-5:2009

Действует

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

DIN 13097-5:2008-11

Отменен

Hypodermic needles - Part 5: Sockets, hubs and connections - Requirements and testing — 14 стр.

BS EN 15986:2011

Действует

Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates — 16 стр.

ISO 10993-17:2002

Действует

Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.

ISO 10993-3:2014

Действует

Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — 42 стр.

ISO 9626:1991

Заменен

Stainless steel needle tubing for the manufacture of medical devices — 16 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 3826-4:2015

Действует

Plastics collapsible containers for human blood and blood components -- Part 4: Aphaeresis blood bag systems with integrated features — 38 стр.

ISO 10993-18:2005

Действует

Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.

DIN 13097-4:2008-09

Отменен

Hypodermic needles - Part 4: Point geometry, requirements and testing

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.