1.1.This guide is intended to assist in the following: 1.1.1. Clarify the difference between accelerated degradation (vs. implanted device at 37oC) and accelerated aging (of packaged product) stored under specific conditions. 1.1.2 Provide guidance on approaches toward conducting accelerated degradation of hydrolysable absorbable polymers at temperatures in excess of 37oC. 1.1.3. Provide guidance on approaches toward conducting accelerated degradation of packaged product containing one or more hydrolysable absorbable polymeric components. 1.1.4 Clarify significance and relationship between Arrhenius Activation Energy and Q10 values when evaluating hydrolysable absorbable polymers 1.1.5. Clarify physical and mechanical properties acceptable for accelerated degradation evaluations and related projections. 22.214.171.124.Molar mass/molecular weight 126.96.36.199.1.Inherent viscosity 188.8.131.52.Tensile Strength 184.108.40.206.1.Longitudinal covalent bond strength (not van der Walls interactions) 1.1.6. Criticality of thermal control 1.1.7. Thermal event transitions 220.127.116.11. Underscore the concern and provide guidance on how to deal with it. 1.1.8. Clarify how to deal with absorbable polymer degradation that is not primarily through hydrolysis.
absorbable, hydrolytically degradable polymer; in vitro; degradation; hydrolysis; surgical implant
Absorbable polymer resins have been developed which degrade very slowly in vivo (two or more years for complete mass loss), and a valid accelerated degradation method would greatly speed the development of surgical implants fabricated from them. This standard would be of value to medical device developers and to regulatory agencies. Currently there are real-time in vitro degradation methods specific to implants fabricated from absorbable polymers (eg, ASTM F1635 and ISO 13781), and an accelerated aging method for medical device packaging (ASTM F1980), but F1980 does not provide guidance for testing hydrolysable polymer devices in vitro. Therefore there is a need for a new standard.
The title and scope are in draft form and are under development within this