GB/T 16886.11-2021Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (English PDF)

Foreword

This document is drafted in accordance with GB/T 1.1-2020 "Directives for

standardization - Part 1.Rules for the structure and drafting of standardizing

documents".

The document is Part 11 of GB/T 16886 "Biological evaluation of medical devices".

GB/T 16886 has issued 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.Physico-chemical, morphological and topographical characterization of

materials;

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

This document replaces GB/T 16886.11-2011 "Biological evaluation of medical

devices - Part 11.Tests for systemic toxicity". Compared with GB/T 16886.11-2011,

the main technical change is as follows.

- Modify the size of groups for chronic toxicity tests (see Table 1; Table 1 of the

2011 edition).

This document, using translation method, is identical to ISO 10993-11.2017

"Biological evaluation of medical devices - Part 11.Tests for systemic toxicity".

China's documents which have a consistent correspondence with the international

documents normatively referenced in this document 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 16886.2-2011 Biological evaluation of medical devices - Part 2.Animal

welfare requirements (ISO 10993-2.2006, IDT).

Attention is drawn to the possibility that some of the elements of this document may be

the subject of patent rights. The issuing authority of this document shall not be held

responsible for identifying any or all such patent rights.

This document was proposed by National Medical Products Administration.

This document shall be under the jurisdiction of National Technical Committee 248 on

Biological Evaluation of Medical Devices of Standardization Administration of China

(SAC/TC 248).

Drafting organizations of this document. Shandong Quality Inspection Center for

Medical Devices, National Institutes for Food and Drug Control.

Main drafters of this document. Wang Xin, Sun Likui, Han Qianqian, Wang Han, Chu

Xiangyu, Xu Jing.

The previous releases of this document and the documents it replaces are as follows.

- It was first issued in 1997 as GB/T 16886.11-1997 and first revised in 2011;

- This is the second revision.

1 Scope

This document specifies requirements and gives guidance on procedures to be followed

in the evaluation of the potential for medical device materials to cause adverse systemic

reactions.

2 Normative references

The contents of the following documents, through normative references in this text,

constitute indispensable provisions of this document. Among them, for dated references,

only the edition corresponding to that date applies to this document. For undated

references, the latest edition (including all amendments) applies to this document.

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

testing within a risk management process

3 Terms and definitions

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

the following apply.

Relationship between the dosage and the magnitude of a defined biological effect either

in an individual or in a population sample.

4 General considerations

There is no absolute criterion for selecting a particular animal species for systemic

toxicity testing of medical devices. However, the species used shall be scientifically

justified and in line with the provisions of ISO 10993-2.

Depending on the objective of the study, the nature of the test article and the route of

exposure, negative, vehicle and/or sham-treated controls should be incorporated into all

systemic toxicity studies.

5 Acute systemic toxicity

Healthy young adult animals are acclimatized to the laboratory conditions for at least 5

d prior to the test. Shorter durations shall be justified. Animals are then randomized and

assigned to the treatment groups.

6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity)

The dose to use for toxicity tests of medical devices shall be defined in relation to the

results of risk assessment, balancing the clinical exposure dose with the use of safety

factors, as applicable. Except for treatment with the test substance, animals in the

control group should be handled in an identical manner to the test group subjects.

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