HealthPack to Feature Expanded Standards Update

Speakers at the upcoming HealthPack event March 6-8 in Albuquerque will update attendees on industry-specific AAMI, ISO, ASTM, and ISTA standards.

“It is important that medical device manufacturers keep abreast of the continuing changes to these standards as they impact the way they do their jobs,” says John Spitzley, who is moderating the event along with Curt Larsen (both principals with Spartan Design Group and members of PMP News's editorial advisory board). “HealthPack is one of the best places to do that and have a chance to talk to/ask questions of the folks who are influential in these activities.”

Jackie Daly Johnson, president of Beacon Convertors and Co-Chair AAMI TC198, WG7, Packaging, will discuss the pending revision of ISO 11607, “Packaging for Terminally Sterilized Medical Devices, Parts One and Two,” and the emerging ISO 16775, the accompanying international guidance document for ISO 11607. (AAMI Technical Information Report 22 continues to support the standard in the United States.)

“More than 400 comments on the previously proposed ISO 16775 draft have been resolved, and the latest proposed revision is now out for balloting,” Johnson explains. “We hope to resolve any new comments at our next meeting in Paris and move the document toward final voting and publication.”

Regarding ISO 11607-1 and -2, “most of the revisions are minor and include updated definitions and date references. New, however, is an annex organizing test methods by type and listing whether each method has repeatability and reproducibility statements and/or precision and bias statements.” AAMI TC198, WG7, Packaging, will convene in April in Paris to review the latest ballots and determine next steps, which could include publication.

The updated ISO 11607 may actually be published within months of its new international guidance, ISO 16775. “We may see the two documents come out with a year of each other,” says Johnson.

Larsen says he expects TIR 22 to be “sunsetted upon the successful balloting of ISO TIR 16775, assuming that it survives in it’s present state.”

Patrick Nolan, president of DDL Labs and past chairman of ASTM Committee D10, will explain recent technical committee discussions to write major revisions to ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. “The revision most likely will involve all the schedules, but of particular note is the potential paradigm shift in vibration testing. Our goal is to develop the most accurate vibration simulation using the most recent published field data. We are working on a composite that incorporates several different overlapping profiles. The composite would allow us to arrive at a nominal profile that averages in all the available profiles. This is just one option for making major changes to the vibration testing schedules. Other options will be presented as well.”

Nolan says that he has been collecting published vibration data profiles recorded in the environment by a number of sources, and he invites companies to submit profiles from their own vibration studies. “It is not too late to get involved,” he says.
Once all the data is in, Nolan will be writing up three different options and circulating them for comment, with a ballot expected later this year.

Also on hand at Healthpack will be Mike Troedel, Engineering Manager Cardinal Healthcare, past chairman of ASTM Committee F02, and Ed Church, ISTA Executive Director, who will update the HealthPack audience on their respective industry groups.

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