14/30266295 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
Hardcopy , PDF
English
31-01-2016
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Superseded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 |
| 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 |
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