GB/T 46147-2025 Active National standards

GB/T 46147-2025 Biological evaluation of medical devices—Measurement of shed and released nanoparticles—Particle tracking analysis

Publish Date: 2025-08-29 Implement Date: 2026-09-01 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/T 46147-2025

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-08-29

Implement Date: 2026-09-01

Pages: 20 pages

Scope

This document describes the sample preparation methods for particle shedding and release in medical devices, the particle size, size distribution, and concentration of nanoparticles in shedding and release media, and the particle tracking analysis methods.
This document is applicable to the characterization and analysis of the particle size distribution and concentration of nanoparticles shed and released from medical devices (including medical devices containing nanomaterials). The measurement of shedding or release of other size particles in medical devices can also refer to this document.