UNE-EN ISO 15378:2016

Superseded

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

Superseded date

10-24-2018

Language(s)

Spanish, Castilian, English

Published date

05-11-2016

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 111
DocumentType	Standard
Pages	78
PublisherName	Asociacion Espanola de Normalizacion
Status	Superseded
SupersededBy	UNE-EN ISO 15378:2018
Supersedes	UNE-EN ISO 15378:2012

Standards	Relationship
UNI EN ISO 15378 : 2011	Identical
DIN EN ISO 15378:2016-03	Identical
EN ISO 15378:2015	Identical
BS EN ISO 15378:2017	Identical
ISO 15378:2015	Identical
EN ISO 15378:2017	Identical
ISO 15378:2017	Identical
NEN EN ISO 15378 : 2017	Identical
I.S. EN ISO 15378:2015	Identical
NF EN ISO 15378 : 2018	Identical
SN EN ISO 15378:2018	Identical
NS EN ISO 15378 : 2017	Identical
I.S. EN ISO 15378:2017	Identical
ONORM EN ISO 15378 : 2018	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