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GB/T 16886.4-2022 English PDF (GBT16886.4-2022)

GB/T 16886.4-2022 English PDF (GBT16886.4-2022)

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GB/T 16886.4-2022: Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

GB/T 16886.4-2022
ICS 11.040.01
CCS C 30
GB/T 16886.4-2022 / ISO 10993-4:2017
Replacing GB/T 16886.4-2003
Biological Evaluation of Medical Devices – Part 4: Selection
of Tests for Interactions with Blood
(ISO 10993-4:2017, IDT)
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 4
Introduction ... 7
1 Scope ... 10
2 Normative References ... 10
3 Terms and Definitions ... 11
4 Abbreviated Terms ... 14
5 Types of Devices in Contact with Blood (as Categorized in ISO 10993-1) ... 16 5.1 Non-blood-contact devices ... 16
5.2 External communicating devices ... 16
5.2.1 General ... 16
5.2.2 External communicating devices that serve as an indirect blood path ... 16 5.2.3 External communicating devices directly contacting circulating blood ... 16 5.3 Implant devices ... 17
6 Characterization of Blood Interactions ... 18
6.1 General requirements ... 18
6.2 Categories of tests and blood interactions ... 26
6.2.1 Recommended tests for interactions of devices with blood ... 26
6.2.2 Non-contact devices ... 26
6.2.3 External communicating devices and implant devices ... 26
6.2.4 Limitations ... 26
6.3 Types of tests ... 27
6.3.1 In vitro tests ... 27
6.3.2 Ex vivo tests ... 27
6.3.3 In vivo tests ... 28
Annex A (Informative) Preclinical Evaluation of Cardiovascular Devices and Prostheses ... 29
Annex B (Informative) Recommended Laboratory Tests -- Principles, Scientific Basis and Interpretation ... 36
Annex C (Informative) Thrombosis -- Methods for in Vivo Testing ... 50
Annex D (Informative) Haematology/Haemolysis - Methods for Testing – Evaluation of Haemolytic Properties of Medical Devices and Medical Device Materials ... 57 Annex E (Informative) Complement - Methods for Testing ... 66
Annex F (Informative) Less Common Laboratory Tests ... 70
Annex G (Informative) Tests Which are not Recommended ... 75
Bibliography ... 78
This document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization – Part 1: Rules for the Structure and Drafting of Standardizing Documents. This Part is Part 4 of GB/T 16886 Biological Evaluation of Medical Devices. GB/T 16886 has published 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: Test 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 Leachable; --- Part 17: Establishment of Allowable Limits for Leachable Substances; --- Part 18: Chemical Characterization of Materials;
--- Part 19: Physic-Chemical, Morphological and Topographical Characterization of Materials;
--- Part 20: Principles and Methods for Immunotoxicology Testing of Medical Devices. This Document replaced GB/T 16886.4-2003 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood. Compared with GB/T 16886.4-2003, the major technical changes are as follows besides the structural adjustments and editorial modifications: a) Change some terms; and add new terms and definitions (see Clause 3 of this Edition; Clause 3 of 2003 Edition);
b) Merge Tables 1 and 2 of 2003 Edition into a new Table 1 of this Edition; reorganize the test types and head of form to emphasize and include material- and mechanically- mediated hemolysis tests and in vitro and in vivo tests for assessing thrombotic risk (see Table 1 of this Edition; Tables 1 and 2 of 2003 Edition);
c) Merge Tables 3 and 4 of 2003 Edition into a new Table 2 of this Edition that briefly lists the recommended and most commonly used tests (see Table 2 of this Edition; Tables 3 and 4 of 2003 Edition);
d) Change the flow chart of the interaction test with blood (see Figure 1 of this Edition; Figure 1 of 2003 Edition);
e) Add procedures for conducting interaction tests with blood (see 6.1.15 of this Edition). This Document equivalently adopt ISO 10993-4:2017 Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood.
Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Document was proposed by National Medical Products Administration. This Document shall be under the jurisdiction of National Technical Committee on Biological Evaluation of Standardization Administration of China (SAC/TC 248).
Drafting organizations of this Document: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection; Sichuan University (Sichuan Testing Center for Biomaterials and Medical Devices; and Guangdong Medical Devices Quality Surveillance and testing Institute.
Chief drafting staffs of this Document: Hou Li, Qiao Chunxia, Yuan Tun, Yang Lifeng, Zhao Zengna, Zheng Liping, and Mo Xiaoyan.
The historical editions of this Standard and the document replaced by this Standard are as follows:
--- It is first-time published as GB/T 16886.4-2003 in 2003.
Biological Evaluation of Medical Devices – Part 4: Selection
of Tests for Interactions with Blood
1 Scope
This Document specifies general requirements for evaluating the interactions of medical devices with blood.
This Document describes:
a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1;
b) the fundamental principles governing the evaluation of the interaction of devices with blood;
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.
2 Normative References
The provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable 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

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