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biolink Regulatory Column – May 2014

Thursday, May 22, 2014   (0 Comments)
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April Showers Bring Sterilization Standards Flowers

Ralph J. Basile, Vice President of Marketing, Healthmark Industries

As it turns out, April was the month of sterilization standards meetings, both domestically and internationally. The month began with ISO/TC 198 meeting down under in Sydney, Australia. 11 days after the completion of those meetings, the AAMI Sterilization Standards Committee met in Baltimore. I had the good fortune to attend both meetings. Someone pointed out that it was to be two famous harbors in less than 2 weeks. Both harbors are fun places to visit, but for some reason, I was more excited at the opportunity to visit Sydney Harbor.

Not surprisingly, the work of both committees, national and international, are very similar. Indeed, The U.S., as a signatory to ISO, actively participates and adopts directly or indirectly many of the ISO standards. AAMI not only manages the U.S. participation in ISO/TC 198, but also administers the International Secretariat for the Committee. There is always an effort to harmonize to the international standards. All things being equal, this makes good sense, as medical device companies in this country, if they export product, have to comply with standards in other markets. The more standards in each country can align with an international standard, the less burdensome these guidelines are on each manufacturer. Of course, differences between markets exist and national standards, including those of AAMI, reflect this.

The highlights? Personally, the dinner cruise on Sydney Harbor was one of mine (and a "side trip" with my wife to The Great Barrier Reef). As far as sterilization standards? Here is a synopsis:

ISO/TC 198:

WG 1, Ethylene oxide sterilization:

  • Adopted a new work item to develop a Technical Specification on the application of ISO 14937 to ethylene oxide sterilization processes utilizing a flexible chamber.

WG 4, Biological indicators

  • ISO 11138-1, -2, -3, -4, -5 (Sterilization of health care products -- Biological indicators)  will be reviewed and revised.

  • ISO 16342 (Method for validation of a reduced incubation period for a biological indicator) should be added to the ISO/TC 198 active work program for development as an International Standard.

  • Work on ISO 11138-6 (Biological indicators for hydrogen peroxide vapor sterilization processes) should be discontinued.

WG 5, Terminology

  • TC 198 agreed to revise ISO/TS 11139, Sterilization of health care products – Vocabulary, as in International Standard.

WG 6, Chemical indicators

  • ISO Approved Work Item 11140-6 (Sterilization of health care products - Chemical indicators - Part 6: Class 2 indicators and process challenge devices for use in performance testing for steam sterilizers) should be reinstated as an active item.

WG 8, Microbiological methods

  • ISO 11737-1:2006 (Sterilization of health care products – Microbiological methods –Part 1: Determination of the population of microorganisms on product) will be reviewed and revised.

  • New work proposal on microbiological testing of biological and tissue-based products for sterilization validation will be circulated for ballot.

WG 9, Aseptic processing

  • The draft of ISO 18362, as revised in Sydney, should be advanced for enquiry ballot as a Draft International Standard, with the new title (Processing of cell-based health care products requiring control of microbial contamination).

  • Confirmation of ISO 13408-6:2009 (Aseptic processing of health care products - Part 6: Isolator systems).

  • Add revision of ISO 13408-2, (Aseptic processing of health care products - Part 2: Filtration) to the Technical Committee's as an active program of work. 

WG 12, Instructions for processing

  • Advance the revision of ISO 17664 (Sterilization of medical devices – Information to be provided by the device manufacturer for processing of medical devices) as a Committee Draft for comment.

WG 13, Washer-disinfectors

  • Advance the revision of ISO 15883-4 (Washer-disinfectors – Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes) for Committee Draft ballot.

TG 1, Assurance of sterility

  • The draft new work proposal as revised in Sydney to develop a Technical Specification (Guidance on aspects of a risk-based approach to assuring sterility of terminally-sterilized, single-use health care products) should be circulated for ballot.

AAMI Sterilization Standards Committee

There are many more committees meeting during AAMI, so I will provide some of the highlights:

WG7, Sterilization Packaging

  • The final proposed amendment/adoption of ISO 11607-2:2006/A1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging (Amendment 1) was released for final 30-day review.

  • The final proposed amendment/adoption of ISO 11607-2:2006/A1, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (Amendment 1) was released for final 30-day review.

  • Review status of ISO 16775/Ed.1, Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.

WG40 Steam Sterilization Hospital Practices

  • The proposed reaffirmation of ANSI/AAMI ST79:2010 (including amendments) was released for final 30-day review.

  • Reviewed comments related to the newest draft of ST79. Comments remain for review for upcoming teleconference meetings.

WG84, Endoscope Reprocessing Work Group

  • Propose to the AAMI Board that this document be changed from a TIR to a Standard.

  • Advance the draft of the document as revised during the meeting as a Committee Draft for ballot.

WG85, Human Factors for Device Reprocessing

  • Advance the draft of TIR as a Committee Draft for ballot.

WG86, Quality systems for device reprocessing

  • Review of comments on first working draft of ST90, Reprocessing of health care products -- Quality management systems for reprocessing for inclusion in next draft of the document.

WG94, Rigid Sterilization Container Systems

  • Reviewed comments related to the newest draft of TIR63/Ed.1, Management of medical devices used in health care facilities that are not owned by the facility and agreed to advance the draft as a Committee Draft for ballot.

WG95, Water Quality for Reprocessing Medical Devices

  • Advance the revision of TIR34 to final 30-day review.

The next AAMI Sterilization Standards Committee meeting will be October 20 - 22 in Alexandria, VA. Sure to be another busy time in the world of sterilization standards.


While it is no longer April but now the month of May, I write the finishing touches on this article as I return from Toronto, Canada from the ASTM F04, Medical Devices, meeting. I participated in sub-committee F04.15.17, Device Cleanliness Validation. Amongst the items under consideration by this group is WK33429, Standard Practice/Guide for Standard test soils for validation of cleaning methods for reusable medical devices, which is a guide to test soils to be used for cleaning validation testing by device manufacturers. Progress for this brand new document is moving along well and hopefully some time in the not too distant future, device manufacturers will have further guidance on the appropriate test soils to use for their devices based upon the clinical application of their devices.

Read more from the May 2014 issue of biolink.

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
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