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DIN EN ISO 14160:1998-06

Отменен
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998); German version EN ISO 14160:1998 — 22 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

DIN EN 46001:1996-09
Отменен
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001; German version EN 46001:1996
DIN EN 46002:1996-09
Отменен
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002; German version EN 46002:1996
DIN EN ISO 9001:1994-08
Отменен
Quality systems - Model for quality assurance in design/development, production, installation and servicing (ISO 9001:1994); trilingual version EN ISO 9001:1994 — 28 стр.
DIN EN ISO 9002:1994-08
Отменен
Quality systems - Model for quality assurance in production, installation and servicing (ISO 9002:1994); trilingual version EN ISO 9002:1994 — 25 стр.
DIN EN ISO 9004-1:1994-08
Отменен
Quality management and quality system elements - Part: 1: Guidelines (ISO 9004-1:1994); trilingual version EN ISO 9004-1:1994 — 55 стр.
DIN EN ISO 9001 Berichtigung 1:2009-12
Отменен
Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008, Corrigendum to DIN EN ISO 9001:2008-12; Trilingual version EN ISO 9001:2008/AC:2009 — 20 стр.
DIN EN ISO 11135:2011-09
Отменен
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2011); German version prEN ISO 11135:2011
DIN EN ISO 11138-1 Berichtigung 1:2008-08
Отменен
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006, Corrigendum to DIN EN ISO 11138-1:2006-09 — 5 стр.
ÖNORM EN ISO 11737-1:2011-01
Заменен
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006 + Cor 1:2007) (consolidated version)
DIN EN ISO 14160:2011-10
Отменен
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011); German version EN ISO 14160:2011 — 48 стр.

На этот документ ссылаются

DIN EN ISO 22442-3:2008-03
Действует
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 — 31 стр.
DIN EN ISO 22803:2006-01
Действует
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); German version EN ISO 22803:2005 — 14 стр.
DIN EN ISO 25539-2:2009-01
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); German version EN ISO 25539-2:2008 — 125 стр.
DIN EN ISO 25539-2:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); German version EN ISO 25539-2:2009 — 124 стр.
DIN EN ISO 25539-1:2009-01
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008 — 113 стр.
DIN EN 556-1:2002-01
Отменен
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 — 8 стр.
DIN EN 556-1:2002-03
Действует
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 — 8 стр.
DIN EN 12442-1:2001-01
Отменен
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; German version EN 12442-1:2000 — 16 стр.
DIN EN ISO 5840:2006-03
Отменен
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005); German version EN ISO 5840:2005 — 99 стр.
DIN EN ISO 13485:2003-11
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003 — 73 стр.
DIN EN ISO 11737-1:2006-08
Отменен
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 — 48 стр.
DIN EN ISO 14937:2001-05
Отменен
Sterilization of health care products - General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000); German version EN ISO 14937:2000 — 37 стр.
DIN EN ISO 14630:2008-04
Отменен
Non-active surgical implants - General requirements (ISO 14630:2008); German version EN ISO 14630:2008 — 23 стр.
DIN EN ISO 14630:2005-08
Отменен
Non-active surgical implants - General requirements (ISO 14630:2005); German version EN ISO 14630:2005 — 20 стр.
DIN EN ISO 11737-1:2009-09
Отменен
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009 — 48 стр.
DIN EN ISO 14160:2011-10
Отменен
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011); German version EN ISO 14160:2011 — 48 стр.