ÖNORM EN ISO 18362

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. 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.