PRZOOM - /newswire/ -
Eden Prairie, MN, United States, 2006/09/28 - With industry requirements constantly changing, DDL is hosting a series of webinars on the new ISO 11607-01 standard and the tests most vital to medical device package validation.
DDL, a leading package, product and material testing services laboratory, is now hosting its ISO 11607 Revisions series of webinars “on-demand”.
The new ISO 11607-01 standard contains many revisions that will affect package testing requirements for medical device manufacturers.
“The more industry regulations change, the more difficult it is for manufacturers to keep up-to-date on requirements for their products’ packaging,” said Patrick Nolan, COO of DDL Inc. “This is why DDL has launched a series of on-demand webinars to help manufacturers understand new requirements that will directly affect their business."
For those manufacturers that are unclear about the package validation process, DDL explains that there are 7 vital tests for validating packaging with the new ISO 1607-01 standard.
1. Seal Peel Testing
2. Bubble Leak Testing
3. Leak Testing By Dye Penetration
4. Drop Testing
5. Compression Testing
6. Load Testing
7. Vibration Testing
“The new ISO 11607-01 standard contains new requirements for medical device package testing,” said Patrick Nolan. “Changes include sample size, accelerated aging protocols, documentation and labeling, which are all instrumental in validating packaging for use.”
Listen to the ISO 11607 Revisions Webinars on-demand on our website.
Watch videos of the 7 tests vital to package validation on our website.
DDL offers expert package testing, product testing and material testing services including shock testing, vibration testing, tensile testing, leak testing and validation. DDL package testing clients find value through its growing suite of PackServices: PackAdvice, a zero-cost package testing consulting service, and PackReview, a DDL approved certification to demonstrate compliance with ISO 11607 (clause 7). DDL Testing Services maintains full service testing labs in Minnesota and California.