1 Scope
This standard specifies the method, specimen preparation, operation procedure and evaluation of in vitro cytotoxicity test for nanomaterials and those integrated in medical devices.
This standard is applicable to the evaluation on in vitro cytotoxicity of nanomaterials and those integrated in medical devices (except that particles or fiber is enveloped or combined to be unreleasable or non-free), including MTT assay and LDH assay which take L929 as the tested cell. This standard is a supplement to GB/T 16886.5.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative document (including any amendments) applies.
GB/T 16886.1 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process
GB/T 16886.5 Biological Evaluation of Medical Devices—Part 5: Test for In Vitro Cytotoxicity
GB/T 16886.12 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials
3 Terms, Definitions and Abbreviations
3.1 Terms and definitions
For the purposes of this standard, the terms and definitions given in GB/T 16886 and those given below apply.
3.1.1
nanomaterial
the material that has its physical structure on a nanoscale in at least one of the three dimensional spaces or that is composed of nanostructure units and has special characteristics
3.1.2
nanomaterial medical devices
medical devices that combine with or contain nanomaterial
Foreword i
Introduction ii
1 Scope
2 Normative References
3 Terms, Definitions and Abbreviations
4 Preparation of Sample, Control Sample and Reagent
5 Cell Lines
6 MEM
7 Test Procedure
8 Data Record and Analysis
9 Acceptance Criteria
10 Result Assessment
Annex A (Informative) Reagents, Consumables and Equipment
Annex B (Informative) Example of 96-hole Plate Sample-adding Formwork
Bibliography
