ISO 13408-1:2008
Aseptic processing of health care products - Part 1: General requirements

Standard No.

ISO 13408-1:2008

Release Date

2008

Published By

International Organization for Standardization (ISO)

Status

Be replaced 2013-05

Replace By

ISO 13408-1:2008/Amd 1:2013

Latest

ISO 13408-1:2023

Scope

1.1 This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. 1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408. NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions.

ISO 13408-1:2008 Referenced Document

• 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 and 11.2
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 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 *， 2018-05-15 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 (includes Redline Version)*， 2015-02-01 Update
• ISO 14644-3 Cleanrooms and associated controlled environments — Part 3: Test methods*， 2020-06-01 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*， 2009-10-01 Update
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices*， 2024-03-01 Update
• ISO 9001 Quality management systems - Requirements [Spanish version]

ISO 13408-1:2008 history

• 2023 ISO 13408-1:2023 Aseptic processing of health care products — Part 1: General requirements
• 2013 ISO 13408-1:2008/Amd 1:2013 Aseptic processing of health care products - Part 1: General requirements; Amendment 1
• 2008 ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
• 1998 ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements