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ISO 11607 to be revised

Get ready for a pretty different ISO 11607.

Nick Fotis, global packaging director for Cardinal Health, tells PMP News that ISO 11607 Parts 1 and 2 have begun to go through the revision process. Fotis recently joined David Johnson from Halyard Health as co-chairs of AAMI Working Group 7 to succeed Jackie Daly Johnson, president of Beacon Converters. Additionally they will be on the U.S. delegation to the ISO Technical Committee (TC) 198/Working Group (WG) 7 Packaging when it meets in December. 

At AAMI’s April meeting, Jackie Daly Johnson was thanked for her work in leading the committee, particularly her efforts in taking ISO TS 16775:2014 through drafts, revisions, and publication.  “ISO 16775 is the ISO guidance on the application of 11607,” explains Fotis. “It is not a standard itself, but a guidance on 11607.  In the United States, it replaces AAMI TIR (Technical Information Report) 22 and is also known as ANSI/AAMI/ISO TIR 16775:2014.”

Fotis reports that a total of 58 comments have been received from all over the world regarding proposed changes to ISO 11607. Jordan Montgomery, technical fellow for Medtronic CRDM Package Engineering, working on behalf of the AAMI TC198/WG 7, suggested that the document be reorganized to flow better, Fotis reports. “Currently, the document starts off with the materials section, but that’s really not how package engineering starts. Instead, the document would start with methods to determine customer and device use requirements. Material selection really flows out of packaging format and sterilization decisions,” Fotis explains.

The U.S. group proposed that “the requirements of the current document be maintained, but the current sections 5 and 6 would be reorganized into sections 5, 6, and 7. This proposed revision came out of a task group from the AAMI WG 7 lead by Montgomery and Jane Severin with David Johnson and Brad Bushman of Standard Textile, as well as input from Patrick Polito of Moog, Miraj Sheth of G.E., and Carol Smith of BSCI,” Fotis continues.

Other revisions were also suggested. “Many are editorial or updates to test standards, but there are also several technical comments,” he says. “These comments were reviewed at the meeting and the United States established a position on these comments to be discussed at the ISO meeting in Berlin in December.” 

In December in Berlin, all members of TC198/WG 7 (representing as many as 28 countries) will be meeting to discuss and prepare the committee draft for revising ISO 11607. All 58 comments will be considered, including the U.S. delegation’s suggestion to reorganize the document’s flow.  “We expect a lot of discussion on the format change,” says Fotis.

The committee draft revision proposal is expected to be available to committee members in early February 2016, after which the AAMI committee will vote and prepare comments. The next steps would include discussing all comments at another TC198/WG 7 meeting and then producing a Draft International Standard, then a vote and comment period on the DIS, then preparation of an Final Draft International Standard for voting only.

Fotis hopes to see more industry engagement. “More people from medical device manufacturers and converters should get involved in AAMI. In general, AAMI members can participate by providing comments that can be incorporated into future documents and help influence the way those documents are structured,” says Fotis.

Fotis adds that once ISO 11607 is revised, ISO 16775 will be reviewed to determine whether changes to ISO 11607 are substantial enough to warrant changes to ISO 16775.

Fotis, Montgomery, and Scholla all serve on PMP News’s Editorial Advisory Board.

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