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DIN ISO 15378:2006-06

Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006), text in German and English — 110 стр.
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Ссылочные документы

DIN EN ISO 9000:2005-12
Отменен
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DIN EN ISO 14644-1:1999-07
Отменен
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999); German version EN ISO 14644-1:1999 — 17 стр.
DIN EN ISO 14644-2:2001-02
Отменен
Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000); German version EN ISO 14644-2:2000 — 9 стр.
DIN EN ISO 14644-3:2006-03
Отменен
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005); German version EN ISO 14644-3:2005 — 72 стр.
DIN EN ISO 14644-4:2003-06
Действует
Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001); German version EN ISO 14644-4:2001 — 55 стр.
DIN EN ISO 14644-5:2005-03
Действует
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004); German version EN ISO 14644-5:2004 — 52 стр.
DIN ISO 9001:1990-05
Отменен
Quality systems; model for quality assurance in design/development, production, installation and servicing (identical with ISO 9001:1987); EN 29001:1987 — 21 стр.
DIN IEC 61025:1993-12
Отменен
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BS IEC 61882:2001
Заменен
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DIN EN ISO 9001:2008-12
Отменен
Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008 — 91 стр.
DIN EN ISO 9004:2000-12
Отменен
Quality management systems - Guidelines for performance improvements (ISO 9004:2000); Trilingual version EN ISO 9004:2000 — 95 стр.
DIN EN ISO 10012:2004-03
Действует
Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 — 56 стр.
DIN EN ISO 11135-1:2007-08
Отменен
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007 — 52 стр.
DIN EN ISO 11137-1:2006-07
Отменен
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006); German version EN ISO 11137-1:2006 — 49 стр.
DIN EN ISO 11137-2:2007-09
Отменен
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007 — 76 стр.
DIN EN ISO 13485:2007-10
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007 — 75 стр.
DIN EN ISO 14001:2005-06
Отменен
Environmental management systems - Requirements with guidance for use (ISO 14001:2004); German and English version EN ISO 14001:2004 — 53 стр.
DIN EN ISO 14644-7:2005-01
Действует
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004 — 60 стр.
DIN EN ISO 14698-1:2004-04
Отменен
Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003); German version EN ISO 14698-1:2003 — 38 стр.
DIN EN ISO 14698-2:2004-02
Отменен
Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003); German version EN ISO 14698-2:2003 — 15 стр.
DIN EN ISO 14937 Berichtigung 1:2005-06
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); Corrigendum to DIN EN ISO 14937:2001-05; German version EN ISO 14937:2000/AC:2005 — 2 стр.
DIN EN ISO 14971 Berichtigung 1:2007-10
Отменен
Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07 — 2 стр.
DIN EN ISO 19011:2002-12
Отменен
Guidelines for quality and/or environmental management systems auditing (ISO 19011:2002); German and English version EN ISO 19011:2002 — 73 стр.
BS ISO/IEC 90003:2004
Заменен
Software engineering. Guidelines for the application of ISO 9001:2000 to computer software — 64 стр.
DIN EN ISO 15378:2007-10
Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006); German and English version EN ISO 15378:2007 — 155 стр.

На этот документ ссылаются

DIN EN ISO 15378:2007-10
Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006); German and English version EN ISO 15378:2007 — 155 стр.
DIN ISO 13926-2:2012-09
Отменен
Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use (ISO 13926-2:2011) — 12 стр.