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EN ISO 11607: Reaffirmed, with a Revision on the Way

February 22, 2011 – 3:34 pm

daphne_111610happyFor those of you who may be wondering about the revision status of EN ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” look no further. It has been reballotted and reaffirmed as EN ISO 11607: 2006/(R)2010, with no changes to its main bodies, Parts 1 and 2. However, there will upcoming revisions to its bibliography and to Annex B, the very helpful appendix on test methods, so stay tuned for EN ISO 11607: 2011.

At the ISO Technical Committee 198 of the Packaging Working Group 7 (ISO/TC 198/WG 7) meeting in Guangzhou, China, in September 2010, the committee reviewed all the comments sent in with the EN ISO 11607 systematic review, reports committee member Jackie Daly Johnson, president at Beacon Converters Inc.

Several of the comments suggested that the Bibliography and Annex B on Test Methods needed to be updated. The working group agreed and decided upon a new format for Annex B, which will differentiate test methods from practices, guidance, and other types of reference documents, as well as indicate which test methods have a statement of precision and bias, Johnson reported.

The group requested that the Convenor, Mike Scholla of DuPont Protection Technologies (and a member of PMP News‘s Editorial Advisory Board), and the Secretary, Annett Müller of DIN, make these adjustments. Members were invited to send in any test methods that were newly published after 2006 for inclusion in Annex B.

The revision will show whether each method has a repeatability statement and a reproducibility statement or whether it is a guide, not an actual test method, explains Scholla. “Users can then make intelligent decisions when choosing to use particular methods,” he says.

“The nice thing about using a standardized test method that has been round-robin tested is that you have those repeatability and reproducibility (R&R) statements. But you still have to validate that you can perform the test method according to the standard in your own lab,” he explains.

Scholla adds that “it is OK to use nonstandardized test methods, but if you do you may have to show how it compares to the standard method. And since you have to do that work anyway, why not use a standardized test method if you can?” he asks.

The revised document is out for comment at this time, to be followed by a DIS and FDIS, and should be published before the end of 2011.

EN ISO 11607 was one of the first standards in the area of TC198 to be subjected to ISO’s new practice of holding a three-year affirmation vote, Scholla explains. It is unclear whether that will happen again or whether it will come up for review in five years.

In terms of guidance for ISO 11607, AAMI (Association for the Advancement of Medical Instrumentation) Technical Information Report (TIR) 22 continues to support the standard in the United States; however, certain members of the ISO delegation asked for an international guidance document.  The resulting guidance has been officially designated ISO 16775 and is out for international comment by members of ISO TC198 WG7, reports Johnson. Those comments will be discussed and resolved at the meeting of ISO TC198 WG7 in Montreal in mid March.

The final guidance will most likely consist of a single document with two parts, explains Scholla, with one serving industry and the other hospitals.

One of the biggest questions Scholla gets about the reaffirmation and pending revision is, “Do I have to buy a new document because EN ISO 11607: 2006/(R)2010 is different from EN ISO 11607: 2006?”

“Not yet,” answers Scholla. “When the new revision comes out with the new addendum at the end of 2011 or perhaps even early 2012, then buy a new one.”

Daphne Allen

Editor’s note: An earlier version of this article incorrectly stated the name of the standard as ISO EN 11607.  We regret the error.

  1. One Response to “EN ISO 11607: Reaffirmed, with a Revision on the Way”

  2. Thanks for an excellent summary of the revision contents of ISO 11607. This is useful info for those interested in the most current standards updates. It appears current compliance requirements effectively remain unchanged.

    By Karen K. Greene on Feb 22, 2011

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