DIN Standards Committee Health Technologies
Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
Abstract
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.
Begin
2018-05-30
WI
00204076
Planned document number
DIN EN ISO 18362
Project number
06301904
Responsible national committee
NA 176-03-10 AA - Aseptic processing
Responsible european committee
CEN/TC 204 - Sterilization of medical devices
Responsible international committee
ISO/TC 198 - Sterilization of health care products
draft standard
Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
2018-11
Order from DIN Media
