标准编号：ISO/TS 20721:2020
中文名称：外科植入物 可吸收金属植入物评估的一般指南和要求
英文名称：Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants
发布日期：2020-09
标准范围
This document established 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. This document describes how the evaluation of these metals can differ
from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that
absorbable metal implants (or subcomponents) are — by design — intended to be absorbed in their
entirety by the host.
This document provides guidance regarding the materials considerations, in vitro degradation/
fatigue characterization, and biological evaluation of medical implants made of absorbable metals. The
provided content is intended to deliver added clarity to the evaluation of these materials and implants
to increase awareness of critical factors and reduce potential for generation of erroneous or misleading
test results.
While this document and the herein described referenced standards contain many suggested alterations
or modifications to currently practiced procedures or specifications, the provided content is intended
to complement, and not replace, current conventions regarding the assessment of implantable implants.
This document covers the evaluation of absorbable metal specific attributes in general and is not
intended to cover application or implant specific considerations. Thus, it is important to consult relevant
implant and/or application specific standards.
This document 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.
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