NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2.

1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

Les exigences et méthodes d'essais associées décrites dans ce document sont de nature générale.

Le présent document ne donne aucune exigence quantitative concernant les paramètres de procédé ou les paramètres du cycle de stérilisation ni d'exigence concernant les essais de performance, la validation ou le contrôle de routine des stérilisateurs étant donné que celles-ci dépendent de la méthode de stérilisation utilisée.

Le présent document n'est pas destiné à remplacer ou modifier les exigences ou méthodes d'essai de normes déjà parues s'appliquant aux stérilisateurs, ou de leurs futures éditions.

Le présent document ne s'applique pas:

— aux stérilisateurs employant un rayonnement à titre d'agent stérilisant;

— aux stérilisateurs destinés au matériel de laboratoire;

— aux stérilisateurs utilisés pour préparer des milieux de culture;

— aux stérilisateurs utilisés pour la bio-décontamination des déchets de laboratoire ou autres déchets, notamment pour l'élimination des pathogènes à haut risque;

— aux systèmes utilisés pour la bio-décontamination de pièces et d'isolateurs;

— aux systèmes utilisés pour la stérilisation en place; ou

— aux laveurs désinfecteurs.

NOTE Le présent document décrit les exigences relatives aux stérilisateurs utilisés dans les établissements de santé, cependant, certains éléments sont applicables aux applications industrielles.

NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135.

No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.

In addition, this document provides

a) background information on the assurance of sterility and sterility assurance level, and

b) guidance on strategies that can allow the achievement of a maximal SAL of 10-6.

ISO/TS 19930:2017 describes the elements of a quality management system which are applied to enable the appropriate selection of a SAL for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10-6.

NOTE It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product.

ISO/TS 19930:2017 is applicable to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

ISO/TS 19930:2017 does not apply

– to selecting a maximal SAL greater than 10-6 for health care product that is able to withstand processing to achieve maximally a SAL of 10-6;

– in cases where a maximal SAL of 10-6 is required and an alternative SAL is not allowed;

– in cases where a maximal SAL of greater than 10-6 (e.g. 10-3) has been accepted by regulatory authorities within their jurisdiction for health care product for defined use;

– to the sterilization of used or reprocessed health care product;

– to sterilization of health care product by filtration.

ISO/TS 19930:2017 does not describe detailed procedures for assessing microbial inactivation.

ISO/TS 19930:2017 does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.

ISO/TS 19930:2017 does not supersede or modify published International Standards for particular sterilization processes. ISO/TS 19930:2017 neither recommends a SAL for a given health care product nor identifies a maximal SAL for a health care product to be labelled "sterile".

NOTE These are matters for regulatory authorities and can vary from country to country.

This method may be used to substantiate a sterilization dose of 25 kGy for any of the following situations:

1. a single batch of product units;
2. initial production of a new product while the sterilization dose is being established by another method;
3. routine production of small batches.

Information collected in applying the method of dose substantiation described in this Technical Specification may be applicable in meeting the product qualification requirements for sterilization dose selection of ISO 11137:1995.