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If you want to know more about SIS, or how standards can streamline your organisation, please visit www. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September and conflicting national standards shall be withdrawn at the latest by September Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN ISO — requirements on determination of resistance characteristics 9. This document gives specific requirements for those biological indicators intended for use in dry heat sterilization processes. The intent is not to promote the use of biological indicators where such use is not advised, but to provide common requirements for the production of those biological indicators that are known to be in use today.

A standard exists providing general requirements for the validation and control of dry heat sterilization processeses see ISO NOTE It is possible that some countries or regions have published other standards covering requirements for sterilization or biological indicators.

Advice on selection, use and interpretation of results when using biological indicators can be found in ISO Requirements for work place safety can be provided by national or regional regulations.

For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document including any amendments applies. ISO , Sterilization of health care products — Biological indicators — Part 1: General requirements ISO , Sterilization of health care products — Biological and chemical indicators — Test equipment 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO apply.

NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a dry heat sterilization process. Other microorganisms shall have D values supporting the application. The z value of the test organisms in the suspension, on the inoculated carrier or in the biological indicator shall be determined at not less than 1 These are examples of suitable products available commercially.

This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of these products.

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