UNE-EN ISO 15378:2016
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
11-05-2016
Publisher
Superseded date
24-10-2018
€150.00
Excluding VAT
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
78
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| EN ISO 15378:2017 | Identical |
| ISO 15378:2017 | Identical |
| NEN EN ISO 15378 : 2017 | Identical |
| EN ISO 15378:2015 | Identical |
| I.S. EN ISO 15378:2015 | Identical |
| BS 903-A49:1984 | Identical |
| ISO 15378:2015 | Identical |
| BS EN ISO 15378:2017 | Identical |
| DIN EN ISO 15378:2016-03 | Identical |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 14644-8:2013 | Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness by chemical concentration (ACC) |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC/ISO 31010:2009 | Risk management - Risk assessment techniques |
| ISO 31000:2009 | Risk management — Principles and guidelines |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 14937:2009 | Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology — Basic and general concepts and associated terms (VIM) |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods |
| ASTM E 2500 : 2013 : REDLINE | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments — Part 3: Test methods |
| ISO 9004:2009 | Managing for the sustained success of an organization — A quality management approach |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO/IEC 90003:2014 | Software engineering — Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 10007:2017 | Quality management — Guidelines for configuration management |
| ISO Guide 73:2009 | Risk management — Vocabulary |
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