Keeping the portfolio of sterilization standards up to date

ISO Technical Committee responsible for sterilization of healthcare products meets in London

BSI has published 72 documents on sterilization and associated equipment and processes. Of these, 46 are adoptions of ISO standards, most of which are common European and International standards. The other British Standards documents are 17 adoptions of European standards that do not have international equivalents and nine standalone British Standards. The standalone British Standards have been in place for a long time and remain either because there is no European or International standard on the topic or because there is a cross-reference to the document from another current standard.

With such a significant portfolio of standards, it is important that they are regularly reviewed and kept current. To this end, the International Standards Committee responsible for standards for sterilization of healthcare products, recently held its 26^th plenary meeting at the BSI headquarters in London. While this committee has several new work items, the bulk of its activity is keeping the existing standards up to date.

One project that has just been completed is the preparation of ISO 11139 – a vocabulary of terms used in sterilization and related equipment and process standards. This is the first edition of terminology to be published as an international standard. The previous edition was designated as a Technical Specification and contained around 50 core terms, each of which was used in more than one sterilization standard. The new document includes approaching 350 terms. These terms are used not only in standards for sterilization processes, but also in standards for sterilizing equipment, washer-disinfectors, packaging and indicators for sterilization. All the terms and definitions have been reviewed based on published documents, documents in preparation and future needs. The terms and their definitions have been revised for consistency of use. This vocabulary is now the source document for these terms.

Work has continued on two work items that will lead to new International documents:

• At an early stage of development is a standard that will specify the requirements for the development, validation and routine control of sterilization using vaporized hydrogen peroxide. In parallel, a standard for biological indicators for sterilization processes using vaporized hydrogen peroxide is being addressed. In addition, in Europea, a standard for sterilizers using vaporized hydrogen peroxide is being prepared.
• A new Technical Specification will define common requirements for sterilizers for terminal sterilization of medical devices in health care facilities. It will address common, general requirements that apply across a range of sterilizing equipment. The Technical specification can then be used:
  • as a template for future revisions of standards for sterilizing equipment for particular sterilization processes, and
  • to apply to equipment for which a particular standard does not exist.

This approach also provides opportunities not only to achieve a comprehensive and consistent set of global standards for sterilizing equipment but also to build on the work done in developing the existing standards for sterilizers at national and regional level to reach an international alignment on the requirements.

This work is relevant to manufacturers of sterile medical devices, as well as providers of sterilization services and manufacturers of related equipment and accessories. You should monitor the development of new standards and the ongoing programme of revision of existing standards to see how your products and processes are affected.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development