BS EN ISO 13408-1:2015
Aseptic processing of health care products. General requirements

Standard No.

BS EN ISO 13408-1:2015

Release Date

2015

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 13408-1:2015

Replace

BS EN ISO 13408-1-2011+A1:2013

BS EN ISO 13408-1:2015 Referenced Document

• 90/385/EEC COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
• 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
• 98/79/EC Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
• ANSI/AAMI ST67-2003 Sterilization of medical devices - Requirements for products labeled "STERILE"
• EN 1822-1 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
• EN 556-2 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"*， 2015-09-01 Update
• IEC 60812 Failure modes and effects analysis (FMEA and FMECA)*， 2018-08-01 Update
• ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*， 2018-11-08 Update
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
• ISO 13408-2 Aseptic processing of health care products — Part 2: Sterilizing filtration*， 2018-01-09 Update
• ISO 13408-3 Aseptic processing of health care products - Part 3: Lyophilization
• ISO 13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies
• ISO 13408-5 Aseptic processing of health care products - Part 5: Sterilization in place
• ISO 13408-6 Aseptic processing of health care products — Part 6: Isolator systems*， 2021-04-13 Update
• ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes*， 2016-03-01 Update
• ISO 14160 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen*， 2020-09-21 Update
• ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
• ISO 14644-2 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration*， 2015-12-01 Update
• ISO 14644-3 *， 2019-08-01 Update
• ISO 14644-4 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up*， 2022-11-28 Update
• ISO 14644-5 Cleanrooms and associated controlled environments - Part 5: Operations
• ISO 14644-7 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
• ISO 14698-1 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
• ISO 14698-2 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data; Technical Corrigendum 1
• ISO 14937 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 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
• ISO 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 20857 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
• ISO 9001 Quality management systems*， 2024-01-01 Update
• ISO 9004 Quality management and quality system elements — Part 3: Guidelines for processed materials*， 2018-04-03 Update
• ISO/TR 14969 Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
• ISO/TS 11139 Sterilization of health care products - Vocabulary

BS EN ISO 13408-1:2015 history

• 2015 BS EN ISO 13408-1:2015 Aseptic processing of health care products. General requirements
• 2011 BS EN ISO 13408-1:2011+A1:2013 Aseptic processing of health care products. General requirements
• 0000 BS EN ISO 13408-1:2011
• 2004 BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements