GB/T 16886.4-2022 PDF in English
GB/T 16886.4-2022 (GB/T16886.4-2022, GBT 16886.4-2022, GBT16886.4-2022)
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Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
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Standards related to (historical): GB/T 16886.4-2022
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GB/T 16886.4-2022: PDF in English (GBT 16886.4-2022) GB/T 16886.4-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
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 ON: APRIL 15, 2022
IMPLEMENTED ON: MAY 01, 2023
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
Foreword
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
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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