YY/T 1292.2-2015Test for reproductive and developmental toxicity of medical devices - Part 2: Prenatal developmental toxicity 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 2. 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 OECD414 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, should be considered reproductive and developmental toxicity test.

a) with possible reproductive tissue or embryo (fetus) direct long-term or permanent contact devices (including resorbable or leachable substances, such as Silicone gel breast implants);

b) storage of medical devices.

This section provides the contact during pregnancy pregnancy maternal medical devices and general information on development of the embryo, the main effect is the parent Shall, death, fetal deformity or change evaluation. This section does not include the contents of functional defects.

Due to the limitations of the impact of the test sample preparation and test method validation, etc., in determining the embryonic developmental toxicity test Before, should take full account of GB/T 16886.1 and GB/T 16886.18 requirements. It should lead to embryonic development drug use in the evaluation of medical devices Basis of risk, based on 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 devices or materials are identified in the extract all the ingredients were not embryonic developmental toxicity, no longer need to be tested. Medical devices After an acceptable biological risk assessment, such as the risk of embryonic development has been excluded, then no further testing.

1 Scope

This section YY/T 1292 specifies the medical device materials or methods of embryo toxicity test.

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.