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

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents". Drafting.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Biological Evaluation of Medical Devices (SAC/TC248).

This document was drafted by: National Center for Nanoscience and Technology, Hefei Hongmeng Standard Technology Research Institute Co., Ltd., and Taizhou Feirongda New Material Technology Co., Ltd.

Limited Liability Company, China National Institutes for Food and Drug Control, Sichuan University, Sichuan Medical Device Biomaterials and Products Testing Center Co., Ltd., National Medical Device Evaluation Center of the State Drug Administration, Oral Medical Device Testing Center of Peking University School of Stomatology, Beijing Municipal Science and Technology Research Institute Research Institute of Analysis and Testing (Beijing Physical and Chemical Analysis and Testing Center), Southwest Jiaotong University.

The main drafters of this document are: Wu Meiyu, Liu Ying, Liu Yanli, Ding Rong, Wang Xiaolei, Yuan Tun, Chen Kuan, Xu Yongxiang, Gao Yuan, Liu Yi, Chen Liang, and Qu Shuxin.

Min Yue, Hua Fang, Liang Jie, Wu Xiaochun, Ge Guanglu, Xie Liming.

Biological evaluation of medical devices Nanoparticle shedding and release measurement Particle tracking analysis

1 Scope

This document describes the sample preparation method for particle detachment and release in medical devices, the particle size of nanoparticles in the detachment and release medium, and particle size distribution.

Methods for particle tracking analysis of distribution and concentration.

This document applies to the characterization of particle size distribution and number concentration of detached and released nanoparticles in medical devices (including nanomaterial medical devices).

Analysis of the detachment or release of particles of other sizes in medical devices can also refer to this document.

2 Normative references

GB/T 6682

GB/T 30544.1

GB/T 30544.4

GB/T 30544.6

GB/T 42348

3 Terms and Definitions

The terms and definitions defined in GB/T 30544.1, GB/T 30544.4, GB/T 30544.6 and GB/T 42348, as well as the following terms and definitions, apply. This document.

4 Principles

Particle tracking analysis (PTA) technology uses a laser light source to illuminate a particle suspension, and then observes and collects the scattering of particles using an optical microscope.

The optical signal is used to track and record the Brownian motion of each particle, utilizing the one-dimensional, two-dimensional, and three-dimensional data of the particles per unit time.

The average spatial displacement yields the diffusion coefficient of particles in the sample solution; according to the Stokes-Einstein equation, the diffusion coefficient can be obtained.

The hydrodynamic diameter is obtained, and thus the particle size information of the particles in the sample system is obtained. The particle size is then estimated from the number of tracked particles and the known sampling volume. The concentration.

5 Instruments and Reagents