ISO 18362:2016
Current
The latest, up-to-date edition.
Manufacture of cell-based health care products Control of microbial risks during processing
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English
15-01-2016
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ISO 18362:2016 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'.
ISO 18362:2016 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.
ISO 18362:2016 does not define biosafety containment requirements.
ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.
| DevelopmentNote |
Supersedes ISO/DIS 18362. (01/2016)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| DS ISO 18362 : 2016 | Identical |
| NEN ISO 18362 : 2016 | Identical |
| BS ISO 18362:2016 | Identical |
| ABNT NBR ISO 18362:2023 | Identical |
| PNE-prEN ISO 18362 | Identical |
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| 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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