1. 范围

1. Scope

      GB/T 16886的本部分描述了评定医疗器械体外细胞毒性的试验方法。

      本部分规定了与器械和/或器械浸提液直接接触或通过扩散的方式与培养细胞接触的孵育方法。

      本部分适用于适宜的生物学参数体外测定哺乳动物细胞的生物学反应。

This part of GB/T 16886 describes test methods to assess the in vitro cytotoxity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device directly or through diffusion.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

2. 规范性引用文件

2. Normative references

      下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。

The following referenced documents are indispensable for the application of this document. For references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

      ISO 10993-1医疗器械生物学评价第1部分:风险管理过程中的评价与试验（Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process)

      ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process

      ISO 10993-12医疗器械生物学评价第12部分：样品制备与参照样品（Biological evaluation of medical devices—Part 12: Sample preparation and reference materials)

      ISO 10993-12 Biological evaluation of medical devices -Part 12: Sample preparation and reference materials

3. 术语和定义

3. Terms and definitions

      ISO 10993-1界定的以及下列术语和定义适用于本文件。

      For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.

      3.1

      培养器皿 culture vessels

      适用于细胞培养的器皿，包括玻璃培养皿、塑料培养瓶或塑料多孔培养板和微量滴定板等器皿。

      Vessels appropriate for cell culture including glass petri dishes, plastic culture flasks or plastic multiwells and microtitre plates.

注：在这些试验方法中，这些器皿只要符合组织培养级别的要求，并适用于哺乳动物细胞培养，可以互换使用。

NOTE: These can be used interchangeably in these methods provided that they meet the requirements ol tissue culture grade and are suitable for use with mammalian cells.

      3.2

      阳性对照材料positive control material

      按照本部分试验时可再现细胞毒性反应的材料。

       Material which, when tested in accordance with this part. provides a reproducible cytotoxic response.

注：阳性对照的目的是显示适用试验系统的反应，例如用有机锡作稳定剂的聚氨酯已用作固体材料和浸提液的阳性对照，苯酚的稀释液用于浸提液的阳性对照。除了一种材料外还可采用纯化学物来证明试验系统的性能。NOTE: The purpose of the positive control is to demonstrate an appropriate test system response. For example, an organotin-stabilized polyurethane has been used as positive control for solid materials and extracts. Dilutions of phenol, for example, have been used as a positive control for extracts. In addition to a material, pure chemicals can also be used to demonstrate the performance of the test system.