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BS ISO 18362:2016

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Manufacture of cell-based health care products. Control of microbial risks during processing
Withdrawn date

07-02-2023

Published date

31-01-2016

Foreword
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 sterilit
Annex A (informative) - Examples of microbial risks for CBHP
Annex B (normative) - Decision trees for application of risk
        assessment for cell-based 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

Defines the minimum requirements for, and gives guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination.

This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled \'sterile\' and to CBHPs not labelled \'sterile\'.

This International Standard is not applicable to:

  • procurement and transport of cell-based starting material used in processing of a CBHP,

  • cell banking,

  • control of genetic material,

  • control of non-microbial product contamination,

  • in vitro diagnostics (IVDs), or

  • natural medicines.

EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.

This International Standard does not define biosafety containment requirements.

This International Standard does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

Committee
CH/198
DevelopmentNote
Supersedes 14/30266295 DC. (02/2016)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

Standards Relationship
ISO 18362:2016 Identical

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 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
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 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
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 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
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

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