ISO/TS 19930:2017

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10-6.

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.

Edition	2017
Published Date	2017
Published By	ISO/TS
Page Count	23