PD ISO/TR 37137:2014

Foreword
1 Scope
2 Terms and definitions
3 General considerations
4 Sterilization considerations
5 Drug-device combination product considerations
6 Part listing and description of absorbable related
  issues in addition to the relevant parts of
  ISO 10993 series 'Biological evaluation
  of medical devices'
Annex A (informative) - Nomenclature of absorb,
        degrade and related terms
Bibliography

Gives interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices.

The objective of this Technical Report is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.