ISO 18362:2016

Indisponible en français

État actuel : Publiée (En cours d'examen)

Le dernier examen de cette norme date de 2021. Cette édition reste donc d’actualité.

	Format	Langue
std 1 145	PDF
std 2 145	Papier

CHF145

Convertir les francs suisses (CHF) dans une autre devise

Résumé

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.

Informations générales

État actuel
: Publiée

Date de publication
: 2016-02

Stade
: Norme internationale confirmée [90.93]
Edition
: 1
Comité technique :
ISO/TC 198

ICS :
11.080.01
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