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 19930:20 ...