What is ISO/TS 20721 about?
ISO/TS 20721 is an international standard on surgery implants that discusses the guideline and requirements for absorbable metallic implants.
ISO/TS 20721 specifies the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them.
ISO/TS 20721 covers the evaluation of absorbable metal-specific attributes in general and is not intended to cover application or implant specific considerations.
Note: ISO/TS 20721 does not apply to non-absorbable or non-metallic components (e.g., polymeric coatings, pharmaceuticals, non-absorbable metals) used in conjunction with absorbable metal implants.
Who is ISO/TS 20721 for?
ISO/TS 20721 on assessment of absorbable metallic implants is applicable to:
- Manufacturers and suppliers of absorbable polymers/metals used in implants
- Biomedical companies
- Implant manufacturers
- Testing laboratories
- Regulatory bodies
Why should you use ISO/TS 20721?
The absorbable metallic implant is of metals and alloys which are intended to use in biomedical applications, mainly for temporary implants, such as bone plates and screws, and porous scaffolds. In this regard, ISO/TS 20721 is an introduction to the field of absorbable metals. ISO/TS 20721 outlines design considerations that differ from non-absorbable metals and provides a detailed description of the absorption process.
As a user of ISO/TS 20721, you can gain clarity on material considerations, vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. As a result, awareness of critical factors and reduction in the potential generation of erroneous or misleading test results can be achieved.