YY/T 1670.1-2019Evaluation of neurotoxicity of medical devices - Part 1: Standard guide for selecting tests to evaluate potential neurotoxicity (English PDF)

Foreword

YY/T 1670 "Evaluation of Neurotoxicity of Medical Devices", including the following sections.

--- Part 1. Guidelines for the selection of trials for evaluating potential neurotoxicity;

--- Part 2. Neuronal cytotoxicity test. This part is the first part of YY/T 1670.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

The purpose of this section is to recommend a set of available biological tests for detecting neurotoxicity caused by medical devices to the nervous system, and

GB/T 16886 series standards and supporting method standards are used together. Consider the requirements of GB/T 16886.1, chemical characterization of materials (GB/T 16886.18), hazard identification and risk assessment (GB/T 16886.12 and YY/T 1512), combined with existing toxicological data.

The nervous system is heterogeneous and consists mainly of neural tissue, including unique cells, proteins, and biochemical pathways.

The central nervous system and the peripheral nervous system. The interaction of a degradation product of a material or material with the nervous system may have a structure of the nervous system And/or features have a negative impact. The ability to repair the nervous system is limited, so preclinical assessment of potential neurotoxicity is very important.

When considering the neurotoxicity of a medical device, consider the contact time and nature between the body tissue and the medical device, and the intended use.

, material characteristics and other information (such as clinical research, post-marketing supervision and adverse events, etc.).

For materials with a clinical history of use in similar neurological applications, chemical characterization can be used to assess similarity.

1 Scope

This section of YY/T 1670 specifies guidelines for the selection of trials for evaluating potential neurotoxicity. This section applies to medical devices Use to assess the potential neurotoxicity of medical devices.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions apply to this document.