BS ISO 18362:2016
Manufacture of cell-based health care products. Control of microbial risks during processing

Standard No.

BS ISO 18362:2016

Release Date

2016

Published By

British Standards Institution (BSI)

Status

Be replaced 2023-02

Replace By

BS ISO 18362:2016+A1:2022

Latest

BS ISO 18362:2016+A1:2022

BS ISO 18362:2016 Referenced Document

• 2001/83/EC DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Community code relating to medicinal products for human use ((Amended by 2003/63/EC, COM(2002) 1 FINAL, and COM(2003) 161 FINAL, COM(2003) 163 FINAL))*， 2023-12-23 Update
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*， 2023-12-23 Update
• ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
• ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
• ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
• ISO 13408-2 Aseptic processing of health care products — Part 2: Sterilizing filtration*， 2018-01-09 Update
• ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
• ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 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 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• ISO 14644-4 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up*， 2022-11-28 Update
• 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 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 22442 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
• ISO 25424 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment*， 2022-01-12 Update
• ISO 29463-1 High efficiency filters and filter media for removing particles from air - Part 1: Classification, performance, testing and marking*， 2017-09-01 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
• ISO/TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1

BS ISO 18362:2016 history

• 2023 BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing
• 2016 BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing