GB/T 16886.5-2017Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity (English PDF)

Foreword

GB/T 16886 "Biological evaluation of medical devices" consists of the following

parts.

- Part 1.Evaluation and testing within a risk management process;

- Part 2.Animal welfare requirements;

- Part 3.Tests for genotoxicity, carcinogenicity and reproductive toxicity;

- Part 4.Selection of tests for interactions with blood;

- Part 5.Tests for in vitro cytotoxicity;

- Part 6.Tests for local effects after implantation;

- Part 7.Ethylene oxide sterilization residuals;

- Part 9.Framework for identification and quantification of potential

degradation products;

- Part 10.Tests for irritation and skin sensitization;

- Part 11.Tests for systemic toxicity;

- Part 12.Sample preparation and reference materials;

- Part 13.Identification and quantification of degradation products from

polymeric medical devices;

- Part 14.Identification and quantification of degradation products from

ceramics;

- Part 15.Identification and quantification of degradation products from

metals and alloys;

- Part 16.Toxicokinetic study design for degradation products and leachables;

- Part 17.Establishment of allowable limits for leachable substances;

- Part 18.Chemical characterization of materials;

- Part 19.Physicochemical, morphological and topographical

characterization of materials;

- Part 20.Principles and methods for immunotoxicology testing of medical

devices.

This Part is Part 5 of GB/T 16886.

This Part is drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces GB/T 16886.5-2003 "Biological evaluation of medical

devices - Part 5.Test for in vitro cytotoxicity". Compared with GB/T 16886.5-

2003, the main technical changes are as follows.

- MODIFY the relevant content of "preparation of liquid extracts of material",

"test procedures" and "assessment of results", and GIVE the qualitative and

quantitative evaluation indicators of cytotoxicity (see 4.2, Clause 8 and

Clause 10 of this Part, 4.2, Clause 8 and Clause 10 of 2003 edition);

- ADD the neutral red uptake (NRU) cytotoxicity test (see Annex A);

- ADD the colony formation cytotoxicity test (see Annex B);

- ADD the MTT cytotoxicity test (see Annex C);

- ADD the XTT cytotoxicity test (see Annex D).

This Part uses the translation method to be identical to ISO 10993-5.2009

"Biological evaluation of medical devices - Part 5.Test for in vitro cytotoxicity".

The documents of China that have a consistent correspondence with the

international documents referenced in this Part are as follows.

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1.

Evaluation and testing within a risk management process (ISO 10993-1.2009,

IDT)

GB/T 16886.12-2017 Biological evaluation of medical devices - Part 12.

Sample preparation and reference materials (ISO 10993-12.2012, IDT)

This Part was proposed by China Food and Drug Administration.

This Part shall be under the jurisdiction of National Technical Committee on

Biological Evaluation of Medical Devices of Standardization Administration of

China (SAC/TC 248).

Drafting organizations of this Part. China Food and Drug Administration Jinan

Quality Supervision and Inspection Center for Medical Devices, China Food

and Drug Administration Beijing Quality Supervision and Inspection Center for

Medical Devices, Jiangsu Institute of Medical Device Testing, Shanghai

Biomaterials Research and Testing Center.

Main drafters of this Part. Hou Li, Sun Xiaoxia, Wang Rui, He Xueying, Gao

Jingxian, Wang Shasha, Sun Jiao, Huang Xhewei.

The previous versions of the standards replaced by this Part are.

- GB/T 16886.5-1997;

- GB/T 16886.5-2003.

1 Scope

This Part of GB/T 16886 describes test methods to assess the in vitro

cytotoxicity of medical devices.

This Part specifies the incubation of cultured cells in contact with a device

and/or extracts of a device either directly or through diffusion.

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 referenced document (including any

amendments) applies.

ISO 10993-1 Biological evaluation of medical devices - Part 1.Evaluation

and testing within a risk management system

3 Terms and definitions

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

3.1

culture vessels

Vessels appropriate for cell culture including glass petri dishes, plastic culture

flasks or plastic multiwells and microtitre plates.

4 Sample and control preparation

5 Cell lines

Established cell lines are preferred and where used shall be obtained from

recognised repositories.

Where specific sensitivity is required, primary cell cultures, cell lines and

organotypic cultures obtained directly from living tissues shall only be used if

reproducibility and accuracy of the response can be demonstrated.

6 Culture medium

The culture medium shall be sterile.

The culture medium with or without serum shall meet the growth requirements

of the selected cell line.

7 Preparation of cell stock culture

Using the chosen cell line and culture medium, prepare sufficient cells to

complete the test. If the cells are to be grown from cultures taken from storage,

remove the cryoprotectant, if present.

8 Test procedures