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
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