ÖNORM EN ISO 10993-11:2018-10

Действует

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Ссылочные документы

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 10993-2:2006

Действует

Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.

ÖNORM EN ISO 10993-11:2009-09

Заменен

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

На этот документ ссылаются

DIN EN ISO 7494-1:2018-10

Действует

Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements (ISO 7494-1:2018) — 29 стр.

DIN EN ISO 7494-1:2011-11

Отменен

Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011); German version EN ISO 7494-1:2011 — 15 стр.

DIN EN ISO 6875:2011-10

Отменен

Dentistry - Patient chair (ISO 6875:2011); German version EN ISO 6875:2011 — 16 стр.

DIN EN ISO 8638:2014-03

Отменен

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014 — 24 стр.

DIN EN ISO 8637-2:2018-12

Действует

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 — 30 стр.

DIN EN ISO 10477:2005-01

Отменен

Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004); German version EN ISO 10477:2004 — 29 стр.

DIN EN ISO 20749:2018-11

Действует

Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017); German version EN ISO 20749:2018 — 40 стр.

DIN EN ISO 24234:2015-08

Отменен

Dentistry - Dental amalgam (ISO 24234:2015); German version EN ISO 24234:2015 — 27 стр.

DIN EN ISO 28158:2010-12

Отменен

Dentistry - Integrated dental floss and handles (ISO 28158:2010); German version EN ISO 28158:2010 — 12 стр.

DIN EN ISO 11070:2015-03

Отменен

Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014); German version EN ISO 11070:2014 — 36 стр.

DIN EN ISO 14607:2009-08

Отменен

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007); German version EN ISO 14607:2009 — 38 стр.

DIN EN ISO 14607:2018-10

Действует

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08); German version EN ISO 14607:2018 — 58 стр.

DIN EN ISO 3826-1:2020-01

Действует

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019); German version EN ISO 3826-1:2019 — 35 стр.

DIN EN ISO 3826-1:2013-09

Отменен

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013); German version EN ISO 3826-1:2013 — 34 стр.

DIN EN ISO 17510-2:2009-07

Отменен

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007); German version EN ISO 17510-2:2009 — 37 стр.

DIN EN ISO 20696:2018-10

Отменен

Sterile urethral catheters for single use (ISO 20696:2018); German version EN ISO 20696:2018 — 41 стр.

DIN EN ISO 20696:2019-04

Отменен

Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2018-09); German version EN ISO 20696:2018 — 41 стр.

DIN EN ISO 22442-1:2016-05

Отменен

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015 — 43 стр.

DIN EN ISO 11135:2014-10

Отменен

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) — 98 стр.

DIN EN ISO 15747:2012-07

Отменен

Plastic containers for intravenous injections (ISO 15747:2010); German version EN ISO 15747:2011 — 20 стр.

DIN EN ISO 8637:2014-03

Отменен

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014 — 30 стр.

DIN EN ISO 10993-1:2010-04

Отменен

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009 — 35 стр.

DIN EN 14683:2019-06

Отменен

Medical face masks - Requirements and test methods; German version EN 14683:2019 — 28 стр.

DIN EN 14683:2019-10

Действует

Medical face masks - Requirements and test methods; German version EN 14683:2019+AC:2019 — 28 стр.

DIN EN ISO 7405:2013-12

Отменен

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd. 1:2013); German version EN ISO 7405:2008 + A1:2013 — 45 стр.

DIN EN ISO 7405:2019-03

Действует

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018 — 56 стр.

DIN EN ISO 7199:2017-05

Отменен

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016); German version EN ISO 7199:2017 — 31 стр.

DIN EN 13060:2015-03

Отменен

Small steam sterilizers; German version EN 13060:2014 — 80 стр.

DIN EN 13060:2019-02

Действует

Small steam sterilizers; German version EN 13060:2014+A1:2018 — 82 стр.

ÖNORM EN ISO 10993-11:2009-09

Заменен

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

DIN EN ISO 10993-12:2012-10

Действует

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012 — 33 стр.