Recent changes in standards development activities have caused difficulties for medical device manufactures (MDM’s) in determining the best alternative for complying with package testing regulations. ISO 11607 requires that sterile medical device package systems be capable of withstanding the transportation and distribution environment. This is typically accomplished by performing a package validation protocol consisting of a series of laboratory tests that simulate the dynamic and environmental hazards associated with the distribution of products to their end use. Annex B of Part 1 in the ISO 11607 standard recommends the use of the ASTM and ISTA standards for simulating these hazards in the laboratory.

A factor in considering which standard to use for compliance purposes is whether the standard is approved as a consensus standard.  ASTM standards are consensus standards because a large group of experts develop and democratically approve the documents for publication. A strict voting regimen is imposed on the standard and all issues, concerns, and comments must be addressed before final approval as an ASTM standard. The ASTM D4169 standard and all ASTM standards have gone through this process.  This is important from the regulatory standpoint since the FDA reviews consensus standards and adds standards to the approved list of consensus standards found in FDA’s guidance document entitled, “Recognized Consensus Standards”. These are test standards that can be used to provide evidence of product efficacy, and compliance to vertical standards such as ISO 11607 in the case of package systems.

ISTA transit testing standards are acceptable in complying with the ISO 11607 standard, even though the standards are not contained in the list of FDA approved standards since the ISTA standards are recommended in the Annex B of the ISO 11607 standard, which is an approved standard, without exception.

So the debate in the industry is which standard to use for compliance with the ISO 11607 standard.  Further discussion is coming up in Part 5 of this Series.