Highlights of Proposed Revisions to ISO 11607

Adapted from HealthPack 2017 presentation, “The Next generation of ISO 11607”, by Nick Fotis

In general, many of the changes will be nothing more than editorial in nature.  However, there are a few technical changes being proposed, and even some changes to definitions, that could affect interpretations and consequently affect some testing protocols.

For example, a proposed technical revision includes the elimination of the requirement for testing to be performed at 23C +/- 1C and 50% +/-2% RH.  This will reduce the burden on testing labs to ensure that test samples and test lab environments are controlled at these very precise temperature and humidity conditions.

Here’s a proposed subtle change in the standard that may have a large effect on test protocols.  The definition of ‘microbial barrier’ is currently the “property of the sterile barrier system which ensures it prevents the ingress of microorganisms, demonstrated under test conditions which consider sterilization process, handling, distribution, transport and storage”; versus the new definition of; “property of the sterile barrier system which ensures that it prevents the ingress of microorganisms”.  The question you might ask is…does the elimination of, “…demonstrated under test conditions…” mean you don’t have to perform tests for microbial ingress?  Yet, the section 6.1.4 requirement states that “The sterile barrier system must maintain sterility until the point of use or until the expiry date”.  Incidentally, all the hazards mentioned in the current definition occur until the point of use or expiry. In addition, you don’t know that microbial ingress of the package is prevented unless you test it in some way. Consequently, no difference…just a more shortened and more concise definition of microbial barrier.

A new proposed note states; “A sterile barrier system which retains a pressure differential compared to atmospheric pressure after sterilization, and until the moment of intended use is considered to maintain sterile barrier integrity.”  This would allow the use of some ASTM standards specifically designed to test package seals for seal integrity using differential pressure.

Another proposed note is added in section 7.2.1 identifying hazards (as)…“shock, vibration, compression, temperature, humidity, and pressure change”, and may require new test methods not previously considered for medical device package performance validations.

Protocols may need to be more explicit on why the package configuration chosen for testing was determined with the added proposed requirement for documenting a “rationale for the worst case sterile barrier system (for determining testing).” Medical devices are packaged in various configurations of kits, parts and quantities in the sterile barrier system, and in the final complete transport package. A written rationale may be required to justify the test package configuration used to represent a group or class of devices and their various packages.

There is a more explicit statement proposed for section 7.1 indicating that “package integrity can be performed by either: whole package testing (testing the entire sterile barrier system) or testing the (material) microbial barrier properties, and the integrity of the seals and closures.” The current version suggests that seal leak testing, combined with the material properties can be used for package integrity verification.

A new definition of ‘Validation’ is more explicit, as it states; “(…is the) confirmation through the provision of objective evidence that the requirements for a specified, intended use or application have been fulfilled”.  Objective evidence is only obtained through quantitative or qualitative information, records or statements of fact pertaining to the performance of the system; and which is based on observation, measurement or test; and which can be verified.

These constitute the highlights of the proposed revisions to Part 1 of ISO 11607.  Other proposed changes to Part 2 will be discussed in future posts