14/30266295 DC : 0

Superseded

View Superseded by

BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS

Available format(s)

Hardcopy , PDF

Superseded date

31-01-2016

Language(s)

English

Publisher

British Standards Institution

Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Process definition
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of product
10 Process simulation and process confirmation
11 Finished product release: test for sterility
12 Finished product release: testing for biological
   contamination that cannot be detected by the
   test for sterility
Annex A (informative) - Examples of specific risks for CBHP
Annex B (normative) - Decision trees for application of risk
        assessment for starting materials
Annex C (informative) - Containment facilities
Annex D (normative) - CBHP starting material
Annex E (normative) - Containment requirements
        for procured, non-sterile starting materials
        before entering the manufacturing area
Annex F (informative) - Typical elements of a process definition
Bibliography

BS ISO 18362.

Committee	CH/198
DocumentType	Draft
Pages	82
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 18362:2016

ISO 13408-4:2005	Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 13408-7:2012	Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
AAMI TIR37 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
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
CFR 16(PTS1000-END) : 0	COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION
ISO 25424:2009	Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 13408-3:2006	Aseptic processing of health care products Part 3: Lyophilization
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 20857:2010	Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 29463-1:2017	High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and marking
ISO 14644-4:2001	Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 13408-6:2005	Aseptic processing of health care products Part 6: Isolator systems
ISO 17665-1:2006	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 13408-5:2006	Aseptic processing of health care products Part 5: Sterilization in place