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Regulatory Update by Michael H. Scholla, Ph.D.

This column was a regular feature in the Tyvek® Rx, but it has been a few years since the last issue of the newsletter, so I’d like to bring everyone up to date.

Global Packaging Standards Update

In 2010, the two global medical packaging standards, EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and EN ISO 11607- 2:2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes were reaffirmed by ballot.

Comments were submitted with the ballots and these comments were resolved during the meeting of ISO Technical Committee Working Group 7- Packaging (TC198/WG7) in Guangzhou, China.  The WG7 committee had the choice to initiate a revision based on the resolved comments or keep these comments for the next revision in five years.  The committee recommended not to wait and submitted New Work Item Proposals (NWIP) to TC98, which were balloted and approved.

These NWIPs have very narrow scopes and revisions of the standards are limited to the comments received during the reaffirmation ballot.  Suggested changes outside the scope have been rejected.

The key amendments are revisions of the definitions of closure integrity, microbial barrier and seal integrity.  Appendix B was also revised by adding new methods, deleting obsolete methods and indicating if there is a statement of repeatability and reproducibility for the method.

Committee Draft for Vote (CDV) ballots on the amendments opened on October 21, 2011, for a three-month period. Ballots in the U.S. must be submitted to the Association for the Advancement of Medical Instrumentation (AAMI) by December 2, 2011.  The U.S. mirror group will convene via teleconference on December 7 to finalize the consensus U.S. position for submission to ISO by December 21, 2011.

The mirror group will reconvene on January 11, 2012, to review the compiled comments submitted by all the voting countries and develop a consensus position on these comments.  The comments will then be resolved during the April 16-20, 2012, meeting of ISO TC198 in Paris, France.

The next steps will be a five-month Draft International Standard (DIS) ballot, resolution of comments, a Final Draft International Standard (FDIS) ballot, and publication if affirmative.

Packaging Guidance Document Moves to Ballot Stage

ISO/DTS 16775 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 is also being balloted starting October 21, 2011, for a three-month period.

The guidance document has two major parts addressing the use of ISO 11607 in medical device manufacturing and healthcare settings. 

The timeline for U.S. comments is the same as described above.  The ballot results and comments will be resolved in Paris.  The document will then issue for a final “yea or nay” vote with only editorial comments permitted.  Once that ballot is completed and approved, the Technical Specification will be published.

All three of the documents described above are also undergoing concurrent CEN balloting.


Carol Herman, a senior U.S. Food and Drug Administration (FDA) executive, has been selected as the new senior vice president for standards policy and programs for the Association for the Advancement of Medical Instrumentation (AAMI).

Herman, who currently serves as director of the standards program at the FDA’s Center for Devices and Radiological Health, will leave the agency at the end of the year and join AAMI on January 1, 2012.

She will be replacing AAMI’s long-term standards leader, Theresa Zuraski, who is retiring at the end of this year.

Zuraski will certainly be missed and Herman will be facing a new set of challenges; however, I know that she is up to the task.

In closing, I would like to thank the AAMI leadership for appointing me Co-Chair of the Sterilization Standards Committee, succeeding Bill Young, whose shoes will be difficult to fill.