GB/Z 16886.22-2022 Active National standards

GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials

Publish Date: 2022-12-30 Implement Date: 2024-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/Z 16886.22-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2022-12-30

Implement Date: 2024-01-01

Pages: 56 pages

Scope

This document provides guidance on the biological evaluation of medical devices composed of or containing nanomaterials, as well as the evaluation of nanomaterials generated during the degradation, wear, or mechanical processing (such as in situ grinding or polishing of medical devices) of medical devices (or components) that do not use nanomaterials in their production process. This document applies to the following aspects: -- Characterization of nanomaterials; -- Sample preparation for nanomaterial testing; -- Release of nanomaterials in medical devices; -- Toxicokinetics of nanomaterials; -- Biological evaluation of nanomaterials; -- Description of results; -- Risk assessment of nanomaterials in medical device evaluation; -- Biological evaluation reports; -- Surface nanostructures of medical devices expected to be generated during design, manufacturing, or processing. This document does not apply to the following: -- Natural and biological nanomaterials used in medical devices without being designed, manufactured, or processed; -- Nanostructures within bulk materials; -- Unintended surface nanostructures of medical devices generated during design, manufacturing, or processing. Note: Examples of unintended surface nanostructures of medical devices include extrusion marks and machining/tool marks. This document aims to provide a general framework and highlight the key aspects to consider when evaluating the safety of medical devices composed of, containing, or generating nanomaterials. Additionally, it highlights several common unanticipated difficulties and obstacles encountered when testing nanomaterials compared to bulk materials or small-molecule chemicals. As a national standardized guidance technical document, this document represents the current technical knowledge related to nanomaterials and does not list or provide detailed test protocols. It can serve as the foundation for future documents focusing on detailed test protoc