Property

Biocompatibility Class
v1.0

Active

URL: https://opendictionary-ecstest.test-bim.com/organization/25869347-9422-4528-ac1c-65954fa4061d/dictionary/9287e0cf-0039-4370-9a67-daf4043be075/property/6d1a34bd-a51b-43f0-b80c-f09454319f03

GUID: 045d5748-f916-412e-b365-ca12344234ff

Definition

The rigorous international regulatory tier verifying a material's absolute chemical inertness and lack of toxicological reactivity when in direct contact with living biological tissue.

Description

A mandatory legal prerequisite for the deployment of medical implants, surgical instrumentation, and advanced wearable health monitors.

Example

Class II

Technical definition

Data type

String

Value list

  • Class I
  • Class II
  • Class III

Usage

Property groups (1)

References

Reference documents (1)

  • ISO 10993 Biological Evaluation of Medical Devices v1.0

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