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GB/T 16886.17-2025 English PDF

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GB/T 16886.17-2025: Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
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GB/T 16886.17: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB/T 16886.17-20251314 Add to Cart 8 days Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents Valid
GB/T 16886.17-2005150 Add to Cart Auto, < 3 mins Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances Valid


Basic data

Standard ID: GB/T 16886.17-2025 (GB/T16886.17-2025)
Description (Translated English): Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.100
Word Count Estimation: 66,673
Date of Issue: 2025-08-29
Date of Implementation: 2026-09-01
Older Standard (superseded by this standard): GB/T 16886.17-2005
Issuing agency(ies): State Administration for Market Regulation; Standardization Administration of China

GB/T 16886.17-2025: Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents


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ICS 11.100 CCSC30 National Standards of the People's Republic of China Replaces GB/T 16886.17-2005 Biological evaluation of medical devices, Part 17. Toxicological risk assessment of medical device components (ISO 10993-17.2023, IDT) Published on 2025-08-29 Implemented on 2026-09-01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Table of Contents

Preface V Introduction VII 1.Scope 1 2 Normative References 1 3.Terms and Definitions 2 4.Symbols and Abbreviations 6. 5.TRA in the biological evaluation process 7 5.1 General Rules 7 5.1.1 Risk Assessment Principles 7 5.1.2 Hazard Identification 8 5.1.3 Risk Assessment 8 5.2 TRA Process 9 6.Component-specific toxicological information 11 6.1 General Requirements 11 6.2 Identification of Hazardous Components 11 6.2.1 General Requirements 11 6.2.2 Applications of TSL 12 6.2.3 Identification of human carcinogens or suspected human carcinogens 13 6.2.4 POD Selection 13 7 TCL, TI and TTC 13 7.1 Derivation of TCL and TI 13 7.2 Applications of TTC 14 8.Estimation of exposure dose 14 9 MoS 15 9.1 General Requirements 15 9.2 Calculation of MoS16 9.2.1 General Requirements 16 9.2.2 Combining MoS values to illustrate the additive nature of damage 17 10 Toxicological Risk Acceptance Criteria 18 10.1 General Requirements 18 10.2 Further risk analysis, risk assessment, or risk control 18 11 Report Requirements 18 Appendix A (Normative) Quality Assessment of Toxicological Data in POD Selection 19 Appendix B (Normative) Derivation of TSL 20 B.1 General Rules 20 B.2 TSL Calculation 20 B.3 Applications of TSL 21 Appendix C (Normative) Derivation of the components TI and TCL for selecting the endpoint 25 C.1 General Requirements 25 C.2 Setting of non-cancer endpoint TI 25 C.2.1 General Requirements 25 C.2.2 Determination of Uncertainty Coefficients 25 C.2.3 Determination of MF 28 C.2.4 Derivation of Non-Carcinogenic TI Values 28 C.3 Setting of Cancer Endpoint TI 28 C.3.1 General Requirements 28 C.3.2 Cancer Risk Assessment 28 C.4 The Establishment of TCL 29 C.4.1 General Requirements 29 C.4.2 Setting the stimulation endpoint TCL 29 C.4.3 Determination of TCL's UF 30 C.4.4 Determination of TCL's MF 30 Appendix D (Informative) Typical Assumptions for Biological Parameters 31 D.1 General Provisions 31 D.2 Assumption 31 D.2.1 Humanity 31 D.2.2 Rats 31 D.2.3 Mice 31 D.2.4 Hamster 32 D.2.5 Guinea Pig 32 D.2.6 Dog 32 D.2.7 Rabbit 32 Appendix E (Normative) Estimation of Exposure Dose 33 E.1 General Requirements 33 E.2 Contact dose estimation based on release kinetics information 33 E.3 Worst-case exposure dose estimation based on maximum release rate 36 E.3.1 General Requirements 36 E.3.2 Another method for calculating EEDmax based on maximum release rate 40 E.4 Estimated exposure dose of irritants 40 Appendix F (Informative) TRA Information Report 41 F.1 Overview 41 F.2 Necessary Arguments 41 F.3 Ingredients, Medical Device Use, and Ingredient Specificity TRA 41 F.4 TRA Table Example 42 References 46

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. This document is Part 17 of GB/T (Z)16886, "Biological Evaluation of Medical Devices". GB/T (Z)16886 has published the following... part. ---Part 1.Evaluation and Experimentation in the Risk Management Process; ---Part 2.Animal Welfare Requirements; ---Part 3.Genotoxicity, Carcinogenicity and Reproductive Toxicity Testing; ---Part 4.Selection of Blood Interaction Tests; ---Part 5.In vitro cytotoxicity assays; ---Part 6.Local Response Testing After Implantation; ---Part 7.Ethylene oxide sterilization residue; ---Part 9.Qualitative and quantitative framework for potential degradation products; ---Part 10.Skin Sensitization Testing; ---Part 11.Systemic toxicity testing; ---Part 12.Sample Preparation and Reference Materials; ---Part 13.Qualitative and quantitative analysis of degradation products from polymer medical devices; ---Part 14.Qualitative and Quantitative Analysis of Ceramic Degradation Products; ---Part 15.Qualitative and quantitative analysis of degradation products of metals and alloys; ---Part 16.Design of the Toxicokinetic Study of Degradation Products and Leachable Materials; ---Part 17.Toxicological Risk Assessment of Medical Device Ingredients; ---Part 18.Chemical Characterization of Medical Device Materials in Risk Management; ---Part 19.Physical Chemistry, Morphology and Surface Characterization of Materials; ---Part 20.Principles and Methods of Immunotoxicological Testing for Medical Devices; ---Part 22.A Guide to Nanomaterials; ---Part 23.Stimulation Tests This document replaces GB/T 16886.17-2005 "Biological evaluation of medical devices - Part 17.Establishment of permissible limits for leachable materials". Compared with GB/T 16886.17-2005, the main technical changes in the revised version are as follows, apart from structural adjustments and editorial modifications. a) The file range has been changed (see Chapter 1, Chapter 1 of the.2005 edition); b) The following terms and definitions have been deleted. “permitted limit”, “benefit factor”, “multi-device exposure factor”, “health benefit”, “health hazard”, “health "Health risk", "health risk analysis", "leached materials", "multiple exposures", "physiological pharmacokinetic model", "proportional exposure factor", "repeated exposures" "Use", "Simultaneous Use", "TCL Correction Factor", "Tolerable Exposure", "Tolerable Risk", "Application Factor" (see.2005 edition) 3.1~3.3, 3.6~3.10, 3.14, 3.17~3.19, 3.21, 3.23, 3.24, 3.26, 3.28); c) The following terms and definitions have been added. "analyte," "lower limit of reference dose," "carcinogen," "component," "dose-response," and "exposure dose." "Hazardous dose", "Human carcinogen", "Known substance", "Irritant", "Safe range", "Starting point", "Release kinetics", "Slope coefficient", "Suspected" Similar to human carcinogens, systemic toxicity, threshold of concern for toxicology, total amount, toxicological risk, toxicological risk assessment, toxicology Screening limits and worst-case estimated exposure doses (see 3.1–3.4, 3.6, 3.7, 3.9–3.12, 3.14, 3.19–3.24, 3.27–) 3.30, 3.32); d) The "General Principles for Establishing Permissible Limits" (see Chapter 4 of the.2005 edition) and the "Tolerable Intake Levels for Certain Leachables" have been removed. "Establishment of TI" (see Chapter 5 of the.2005 edition) and "Calculation of Tolerable Contact (TE)" (see Chapter 6 of the.2005 edition). "Feasibility Assessment" (see Chapter 7 of the.2005 edition), "Benefit Assessment" (see Chapter 8 of the.2005 edition), "Permissible Limits" (see...) Chapter 9 of the.2005 edition); e) Added "Symbols and Abbreviations" (see Chapter 4), "TRA in the Biological Evaluation Process" (see Chapter 5), and "Component-Specific..." "Toxicological Information" (see Chapter 6), "TCL, TI, and TTC" (see Chapter 7), "Exposure Dose Estimation" (see Chapter 8), "MoS" (See Chapter 9), “Acceptance Criteria for Toxicological Risks” (see Chapter 10); f) The sections on “Risk assessment of leachable mixtures” (see Appendix B of the.2005 edition) and “Permissible contact with systems and body surfaces” have been removed. The maximum dose of a medical device may be transferred to the patient within a limited range (see Appendix C of the.2005 edition); g) Added "Toxicological Data Quality Assessment When Selecting PODs" (see Appendix A), "Derivation of TSL" (see Appendix B), and "Derivation of Selection" Choose the endpoint for the component TI or TCL (see Appendix C), and estimate the exposure dose (see Appendix E). This document adopts ISO 10993-17.2023 "Biological evaluation of medical devices – Part 17.Toxicological effects of components of medical devices". Risk assessment. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Biological Evaluation of Medical Devices (SAC/TC248). This document was drafted by. Shandong Provincial Institute for Medical Device and Pharmaceutical Packaging Inspection, China National Institutes for Food and Drug Control, and Boston Scientific International Medical Products Co., Ltd. Medical Trade (Shanghai) Co., Ltd. The main drafters of this document are. Sun Xiaoxia, Liu Chenghu, Wang Han, Zhang Ying, Sun Lingxiao, Fu Bufang, Liu Xiaohui, Han Qianqian, Qin Yue, and Yang Jing. The release history of this document and the document it replaces is as follows. ---First published in.2005 as GB/T 16886.17-2005; ---This is the first revision.

introduction

Medical devices or materials that come into direct or indirect contact with the patient's or user's body are expected to be free from contamination when fulfilling their intended purpose. Acceptable risks include biological and toxicological risks. Therefore, medical devices typically require biological evaluation during the risk management process. Price is used to assess its safety. GB/T (Z)16886 specifies a process that medical device manufacturers can use to identify medical devices that are related to medical safety. Device-related biological hazards, estimating and evaluating the risks associated with these hazards and controlling these risks throughout the entire lifecycle of medical devices. Effectiveness of monitoring and control during the period. ISO 10993-1, consistent with ISO 14971, reaches a consensus on conducting biological assessments in the risk management process. 18.This includes analytical methods for identifying and quantifying hazardous components in medical devices to enable the assessment of their toxicological risks. Furthermore, ISO 10993-18 specifies when to consider conducting a toxicological risk assessment in accordance with this document. This document addresses the toxicological risks of specific medical device components used in the biological evaluation process as specified in ISO 10993-1 and Chapter 1. The requirements for the evaluation process are specified. For example, the biological risk analysis of medical devices includes obtaining the results specified in section 6.2 of GB/T 16886.1-2022. The composition information is as described in ISO 10993-18.The degree to which composition information is needed depends on the material formulation, manufacturing process (i.e., processing aids). This includes knowledge of the formulation, manufacturing process, etc., existing non-clinical or clinical information, and the nature and duration of human contact with the medical device. This toxicology... The risk assessment process is based on the following principles. using only the minimum necessary information to assess the likelihood of any adverse reactions involving medical device components. When exposed to harmful doses, biological evaluation and risk assessment processes are the most efficient and effective. The processes, requirements, and standards specified in this document... The methods aim to derive information that is useful for the overall biological risk assessment of the final product. ---Whether the quantity of components inside, on, or extracted from a medical device could cause potential health harm; ---Based on body weight or surface area, the tolerable intake or tolerable exposure level of a component over a specific time period is derived. The level is considered not to cause significant health harm; ---Estimate the exposure dose of each component under worst-case conditions and the subsequent toxicological risk assessment; ---Toxicological studies were conducted based on the tolerable intake or tolerable exposure level and the estimated exposure dose under worst-case conditions for each component. Risk assessment. This document is intended for use by toxicologists or professionals with theoretical knowledge and practical experience, who have received training and practical experience. They must obtain the corresponding qualifications and be able to make scientific judgments based on scientific data and relevant knowledge of medical devices. Finally, this document expands upon the previous version, clarifying when a toxicological risk assessment is recommended and how to calculate a worst-case scenario. The estimated exposure dose of the component, and when it is appropriate to use other methods [such as frequency-based dose-response (if any), probability-based dose-response, or bioassay], to determine the appropriate exposure dose. [Physical experiments] determine the likelihood of health damage occurring. The proposed "Biological Evaluation of Medical Devices" will consist of 21 parts. ---Part 1.Evaluation and Testing in the Risk Management Process. The aim is to protect humans from the potential risks associated with the use of medical devices. In the context of biological risk, the biological evaluation of medical devices is described within the risk management process and used as a component of the overall evaluation of medical devices. An integral part of the development process. ---Part 2.Animal Welfare Requirements. The aim is to maximize the use of scientifically sound non-animal testing to ensure the effectiveness of animal welfare assessments. The biological properties of the materials used in the instruments were tested in animal experiments in accordance with recognized ethical and scientific principles. ---Part 3.Genotoxicity, Carcinogenicity, and Reproductive Toxicity Testing. The purpose is to provide testing for samples identified as having potential genotoxicity, carcinogenicity, or reproductive toxicity. Provide evaluation guidelines and methods for medical devices with sexual or reproductive toxicity. ---Part 4.Selection of Blood Interaction Tests. The aim is to provide a universal approach for evaluating medical device-blood interactions. Require. ---Part 5.In vitro cytotoxicity assays. The purpose is to provide assay methods for evaluating the in vitro cytotoxicity of medical devices. ---Part 6.Post-implantation Local Response Testing. The purpose is to provide a basis for evaluating the local response after implantation of biomaterials used in medical devices. Provide experimental methods. ---Part 7.Ethylene Oxide Sterilization Residue. The purpose is to determine the residual levels of EO on single medical devices sterilized with ethylene oxide (EO). The permissible limits for 2-chloroethanol (ECH) residues, EO and ECH residue levels provide testing procedures and determine whether the device is safe. Testing methods are provided at the factory. ---Part 9.Qualitative and Quantitative Framework for Potential Degradation Products. The aim is to provide a framework for the systematic evaluation of potential and observed degradation products of medical devices. This provides basic principles for the degradation of the material and the design and implementation of degradation studies. ---Part 10.Skin Sensitization Testing. The purpose is to provide a method for evaluating the potential skin sensitization of medical devices and their constituent materials. ---Part 11.Systemic Toxicity Testing. The purpose is to provide testing methods for evaluating medical device materials that may cause potential adverse systemic reactions. Legal guidelines. ---Part 12.Sample Preparation and Reference Materials. The purpose is to provide a framework for sample preparation methods and reference materials in the biological evaluation of medical devices. Materials provide selection guidelines. ---Part 13.Qualitative and Quantitative Analysis of Degradation Products from Polymer Medical Devices. The aim is to provide a basis for the qualitative and quantitative analysis of degradation products from finished polymer medical devices used clinically. The design of qualitative and quantitative experiments for the degradation products of instruments in simulated environments provides general requirements. ---Part 14.Qualitative and Quantitative Analysis of Ceramic Degradation Products. The aim is to develop solutions for quantitatively analyzing degradation products from ceramic materials. Provide a method. ---Part 15.Qualitative and Quantitative Analysis of Degradation Products of Metals and Alloys. The aim is to provide information for metal medical devices or those intended for clinical use. The degradation products of the corresponding material samples provide general requirements for qualitative and quantitative experimental design. ---Part 16.Design of Toxicokinetic Studies of Degradation Products and Leachable Materials. The aim is to provide design guidance related to medical devices. And the principles of conducting toxicokinetics studies. ---Part 17.Toxicological Risk Assessment of Medical Device Components. The purpose is to provide a basis for toxicological risk assessment of medical devices and for the assessment of specific... Provide evaluation methods for whether there are significant hazards associated with contact with the components. ---Part 18.Chemical Characterization of Medical Device Materials in Risk Management. The aim is to provide qualitative and qualitative information on the components of medical devices. It provides a framework for quantitatively identifying biohazards and estimating and controlling biological risks in material composition, as needed. ---Part 19.Material Physical Chemistry, Morphology, and Surface Characterization. The aim is to identify and evaluate materials for final medical devices. The physical properties of the material, such as physicochemical, morphological, and surface properties (PMT), provide various parameters and testing methods. ---Part 20.Principles and Methods of Immunotoxicological Testing for Medical Devices. The purpose is to provide guidance on potential immunotoxicity testing of medical devices. This provides an overview of immunotoxicology and methodological guidance for testing the immunotoxicity of different types of medical devices. ---Part 22.A Guide to Nanomaterials. The purpose is to provide a biological evaluation of medical devices that contain, produce, or are composed of nanomaterials. Provide guidance. ---Part 23.Stimulation Testing. The purpose is to provide a method for evaluating the potential stimuli of medical devices and their constituent materials. Biological evaluation of medical devices, Part 17. Toxicological risk assessment of medical device components 1.Scope This document specifies the process and requirements for conducting toxicological risk assessments of medical device components, as well as the assessment of whether a particular contact component has significant risks. Methods and guidelines for assessing harm. As described in ISO 10993-1, toxicological risk assessment can be used as part of the biological evaluation of the final product. This document applies to chemical characterization information obtained according to ISO 10993-18.It is required for component information or analytical chemical data (such as impregnation data). A toxicological risk assessment (using extractable or leachable data) ......
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