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GB/T 16886.6-2022 English PDF (GBT16886.6-2022)

GB/T 16886.6-2022 English PDF (GBT16886.6-2022)

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GB/T 16886.6-2022: Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation

GB/T 16886.6-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.6-2022 / ISO 10993-6:2016
Replacing GB/T 16886.6-2015
Biological evaluation of medical devices -
Part 6: Tests for local effects after implantation
(ISO 10993-6:2016, IDT)
ISSUED ON: APRIL 15, 2022
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 8
2 Normative references ... 9
3 Terms and definitions ... 9
4 Common provisions for implantation test methods ... 10
5 Test methods, general aspects ... 12
6 Test report ... 20
Annex A (Normative) Test methods for implantation in subcutaneous tissue ... 22 Annex B (Normative) Test method for implantation in muscle ... 25
Annex C (Normative) Test method for implantation in bone ... 27
Annex D (Normative) Test method for implantation in brain tissue ... 30 Annex E (Informative) Examples of evaluation of local biological effects after implantation ... 36
Bibliography ... 39
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 6 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 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 16886.6-2015 "Biological evaluation of medical devices - Part 6: Tests for local effects after implantation". Compared with GB/T 16886.6-2015, in addition to editorial changes, the main technical changes are as follows: a) Add guidance on biological evaluation of absorbable medical devices (see 5.1.2, 5.3.3, 5.3.4, 6.6);
b) Add "Test method for implantation in brain tissue" (see Annex D).
This document is identical to ISO 10993-6:2016 "Biological evaluation of medical devices - Part 6: Tests for local effects after implantation".
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, Shandong University.
Biological evaluation of medical devices -
Part 6: Tests for local effects after implantation
1 Scope
This document specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
This document applies to materials that are
- solid and non-solid, such as porous materials, liquids, gels, pastes, and particulates, - non-absorbable, and
- degradable and/or absorbable, which may be solid or non-solid.
This document can also be applied to medical devices that are intended to be used topically in clinical indications where the local surface or lining might have been breached, in order to evaluate local tissue responses.
Note 1: The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. The objective is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined. The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established.
These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading.
This document does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity.
Note 2: The long-term implantation studies intended for evaluation of local biological effects might provide insight into systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. Systemic toxicity studies conducted by implantation might satisfy the requirements of this document. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both documents is to be fulfilled.
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
Note: GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, IDT).
ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal welfare requirements
Note: GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006, IDT).
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Note: GB/T 16886.4-2022 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017, IDT).
ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Note: GB/T 16886.12-2017 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012, IDT).
ISO 10993-16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Note: GB/T 16886.16-2021 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017, IDT). 3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-2, ISO 10993-12, ISO 10993-16 and the following apply.
3.1
Absorb/absorption

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