FprEN ISO 18362

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016) FprEN ISO 18362

General information

40.98 Project deleted   Dec 14, 2020

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

ABANDON
FprEN ISO 18362
40.98 Project deleted
Dec 14, 2020

Relations

Adopted from ISO 18362:2016 IDENTICAL