ASTM D4169-14 is the current FDA approved consensus standard. The typical test regimen for medical device package testing is distribution cycle 13 (DC 13). The test intensity level most commonly employed is Assurance Level 1, since medical devices are high value products and there must be a high assurance that the product reaches their end use location in a usable condition and that the product maintains its efficacy. The risk of a breach in package integrity or a product that does not perform as intended could be higher than acceptable. The final risk level is to be determined by the MDM. It is possible that the determination of the risk factor could result in the MDM performing a test at a lower intensity level via risk-based assessment: Assurance Level 2. This standard has been shown to be a robust but realistic distribution simulation test due to its long history of use and package assessment success.
The new D 4169-16 distribution simulation standard has not yet been approved as of this writing, and is currently pending and will eventually be approved by the agency. The revision of this standard includes significant changes to the vibration testing regimen and is thought to be more realistic than previous vibration levels due to new field data being analyzed and evaluated. More on this in a future blog post.
Some MDM’s have requested the ISTA 3A test standard for compliance to the ISO 11607. This is acceptable for compliance to the ISO 11607. The test standard is more difficult and complex to perform and the test regimen is significantly more robust and severe for medical device packages than the D 4169 standard. Consequently, the possibility of the package failing the test is higher, resulting in potential package redesign and retesting costs.
To complicate matters more, ASTM has approved and published a test standard similar to the ISTA 3A test standard. The designation is ASTM D 7386-16 (the single parcel delivery standard noted in Part 3 of this Series). Stay tuned for more blog posts in the future on the implications of and changes to all of these standard test methods.