YY/T 1292.1-2015Test for reproductive and developmental toxicity of medical devices - Part 1: Screening test (English PDF)

Foreword

YY/T 1292 "Medical Devices reproductive and developmental toxicity test" intended to divide part of the publication, currently plans to release The following components.

--- Part 1. Screening test;

--- Part 2. embryo toxicity test; This section YY/T 1292 Part 1. This section drafted in accordance with GB/T 1.1-2009 given rules.

Some elements of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.

Introduction

Detect potential reproductive GB/T 16886.3 given and test methods for developmental toxicity substances are the Organization for Economic Cooperation and Development (OECD) method "chemical testing guidelines" set forth, but these methods are made for the development of chemical properties, but did not give details Test procedure, and therefore not suitable for the direct detection of medical devices or materials. The original part of the basic reference test method OECD421 Then, and according to the characteristics of medical devices or materials test methods were appropriate modifications, it provides detailed test procedure can be used as

GB/T 16886.3 to one standard method of reproductive and developmental toxicity test.

Reproductive medical devices or materials and developmental toxicity potential has a very important influence on human health. Especially for medical resorbable Devices containing leachables or medical devices. GB/T 16886.3 recommended the following medical devices or materials, in the absence of exclusion of reproductive and developmental toxicity Lower risk evidence, consider reproductive and developmental toxicity test.

a) with possible reproductive tissue or embryo (fetus) direct long-term or permanent contact devices, resorbable or leachable material (such as silicon condensate Gel breast implants);

b) storage of medical devices.

This section used to design the evaluation of medical devices or material female and/or male reproductive function on the test, such as gonadal function, mating Behavior, pregnancy, fetal development and childbirth, the results of the information obtained is limited.

Due to the limitations of the impact of the test sample preparation and test method validation, etc., in determining the reproductive and developmental toxicity test Previously, the need for full consideration of GB/T 16886.1 and GB/T 16886.18 requirements. Need as reproductive and made use of in the evaluation of medical devices Fertility risk of toxicity on the basis of the decision to be tested shall be demonstrated.

Of resorbable or leachable medical devices containing filter material, if there is in the absorption, metabolism, distribution and research sufficiently reliable data, or Medical device materials were identified in extracts of all the ingredients or when no reproductive and developmental toxicity, no longer need to be tested. Medical devices After mechanical biological acceptable conduct risk assessment, risk such as reproductive and developmental toxicity has been ruled out, you do not need the test.

1 Scope

This section YY/T 1292 specifies the medical device or material reproductive and developmental toxicity screening test methods.

This section applies to medical devices or materials reproductive and developmental toxicity test.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements

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

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

3 Terms and Definitions

GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 defined and the following terms and definitions apply to this document.