1. 范圍

1. Scope

      GB/T 16886的本部分描述了評定醫療器械體外細胞毒性的試驗方法。

      本部分規定了與器械和/或器械浸提液直接接觸或通過擴散的方式與培養細胞接觸的孵育方法。

      本部分適用于適宜的生物學參數體外測定哺乳動物細胞的生物學反應。

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. 規范性引用文件

2. Normative references

      下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。

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醫療器械生物學評價第1部分:風險管理過程中的評價與試驗（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醫療器械生物學評價第12部分：樣品制備與參照樣品（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. 術語和定義

3. Terms and definitions

      ISO 10993-1界定的以及下列術語和定義適用于本文件。

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

      3.1

      培養器皿 culture vessels

      適用于細胞培養的器皿，包括玻璃培養皿、塑料培養瓶或塑料多孔培養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：在這些試驗方法中，這些器皿只要符合組織培養級別的要求，并適用于哺乳動物細胞培養，可以互換使用。

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

      陽性對照材料positive control material

      按照本部分試驗時可再現細胞毒性反應的材料。

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

注：陽性對照的目的是顯示適用試驗系統的反應，例如用有機錫作穩定劑的聚氨酯已用作固體材料和浸提液的陽性對照，苯酚的稀釋液用于浸提液的陽性對照。除了一種材料外還可采用純化學物來證明試驗系統的性能。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.