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GB/T 16886.18-2022: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 16886.18: Historical versions
Similar standardsGB/T 16886.18-2022: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT16886.18-2022 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100.20 CCS C 30 GB/T 16886.18-2022 / ISO 10993-18.2020 Replacing GB/T 16886.18-2011 Biological Evaluation of Medical Devices – Part 18. Chemical Characterization of Medical Device Materials within a Risk Management Process (ISO 10993-18.2020, IDT) Issued on. DECEMBER 30, 2022 Implemented on. JANUARY 01, 2024 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 4 Introduction... 7 1 Scope... 11 2 Normative References... 12 3 Terms and Definitions... 12 4 Abbreviated Terms... 18 5 Characterization Procedure... 19 5.1 General... 19 5.2 Establish medical device configuration and material composition... 22 5.2.1 General... 22 5.2.2 Information gathering... 23 5.2.3 Information generation... 24 5.3 Assess material/chemical equivalence to a clinically established material or medical device... 25 5.4 Assess the hypothetical worst-case chemical release based on total exposure to the medical device’s chemical constituents... 26 5.4.1 Establish the hypothetical worst-case chemical release... 26 5.4.2 Assess the hypothetical worst-case chemical release... 26 5.5 Establish an analytical evaluation threshold... 28 5.6 Estimate the chemical release; perform extraction study... 28 5.7 Assess the estimated chemical release (extractables profile)... 31 5.8 Determine the actual chemical release; perform leachable study... 31 5.9 Assess the actual chemical release (leachable profile)... 33 5.10 Exiting the chemical characterization process... 33 6 Chemical Characterization Parameters and Methods... 33 6.1 General... 33 6.2 Material composition... 34 6.3 Extractables and leachable... 36 6.4 Structural composition or configuration... 38 6.5 Analytical methods... 39 7 Reporting of the Chemical Characterization Data... 40 Annex A (Informative) General Principles of Chemical Characterization... 42 Annex B (Informative) Information Sources for Chemical Characterization... 47 Annex C (Informative) Principles for Establishing Biological Equivalence... 52 Annex D (Informative) Principles of Sample Extraction... 56 Annex E (Informative) Calculation and Application of the Analytical Evaluation Threshold (AET)... 71 Annex F (Informative) Qualification of Analytical Methods Used for Extractables/Leachable... 82 Annex G (Informative) Reporting Details for Analytical Methods and Chemical Data ... 86 Bibliography... 90ForewordThis 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 Document is Part 18 of GB/T (Z) 16886 Biological Evaluation of Medical Devices. GB/T (Z) 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.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 Leachable; --- Part 17.Establishment of Allowable Limits for Leachable Substances; --- Part 18.Chemical Characterization of Medical Device Materials within a Risk Management Process; --- Part 19.Physic-Chemical Morphological and Topographical Characterization of Materials; --- Part 20.Principles and Methods for Immunotoxicology Testing of Medical Devices; --- Part 22.Guidance to Nanomaterials. This Document replaced GB/T 16886.18-2011 Biological Evaluation of Medical Devices - Part 18.Chemical Characterization of Materials. Compared with GB/T 16886.18-2011, the major technical changes of this Document are as follows besides the structural adjustments and editorial modifications. a) Change the scope (see Clause 1 of this Edition; Clause 1 of the 2011 Edition); b) Add new terms and definitions (see Clause 3 of this Edition); c) Change and add new abbreviations (see Clause 4 of this Edition; Clause 4 of the 2011 Edition); d) Change "General Principles" to "General"; and further elaborate on the application of chemical characterization and the relationship with risk assessment (see 5.1 of this Edition; Clause 5, 6.1 of the 2011 Edition); e) Change "Step 1 -- Qualitative information" into "Determine the structure and material composition of medical devices"; and elaborate on the collection and generation of information required for chemical characterization (see 5.2 of this Edition; 6.2 of the 2011 Edition); f) Change "Step 2 -- Material equivalence" into "Evaluate material/chemical equivalence with clinically established materials or medical devices"; and elaborate on material/chemical equivalence in more detail (see 5.3 of this Edition; 6.3 of the 2011 Edition); g) Change "Step 3 -- Quantitative information", "Step 4 - Quantitative risk assessment" and "Step 5 - Estimating exposure to chemicals"; and describe in detail the progressive generation steps for quantitative chemical characterization data used for risk assessment (see 5.4, 5.5, 5.6, 5.7, 5.8, 5.9 of this Edition; 6.3, 6.4, 6.5 of the 2011 Edition); h) Change the general rules in "Chemical characterization parameters and methods"; and add a description about the dissolution test (see 6.1 of this Edition; 7.1 of the 2011 edition); i) Classify and integrate the characterization parameters and test methods of polymers, metals and alloys, ceramics and natural macromolecules; and make some changes (see 6.2, 6.4 of this Edition; 7.2, 7.3, 7.4, 7.5 of the 2011 Edition); j) Change "Report of obtained data" into "Report of chemical characterization data"; and change the information to be included in the report (see Clause 7 of this Edition; Clause 8 of the 2011 Edition); k) Change the chemical characterization flow chart (see Figures 1~ 4 of this Edition; Figure A.1 of the 2011 Edition). This Document equivalently adopts ISO 10993-18.2020 Biological Evaluation of Medical Devices – Part 18.Chemical Characterization of Medical Device Materials within a Risk Management Process. This Document made the minimum editorial modification as follows. --- Incorporated the amendments of ISO 10993-18.2020/Amd.1.2022; and the outer margins of the terms involved are marked with vertical double lines (‖). 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 on Medical Device of Standardization Administration of China (SAC/TC 248). Drafting organizations of this Document. Shandong Institute of Medical Devices and Drug Packaging Inspection; and Baxter Healthcare (Suzhou) Co., Ltd. Chief drafting staffs of this Document. Shen Yong, Luo Hongyu, Bo Xiaowen, Liu Aijuan, and Lu Qin. The historical editions replaced by this Document are as follows. --- GB/T 16886.18-2011 was first-time published in 2011; --- It is the first-time revised hereby.1 ScopeThis Document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization.2 Normative ReferencesThe 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 process3 Terms and DefinitionsFor the purposes of this document, the definitions in ISO 10993-1 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses. Method whose purpose is to discover, identify and semi-quantitatively estimate the concentration of all relevant analytes in a test sample above an established reporting threshold (such as the AET).4 Abbreviated TermsThe abbreviated terms given in Table 1 are used in this document.5 Characterization ProcedureA medical device’s ability to interact with a potentially affected individual requires contact, as established in ISO 10993-1.For medical devices (or components) that do not have direct or indirect contact with the body, chemical characterization is not necessary. The hypothetical worst-case chemical release is established by the configuration and composition of the medical device.6 Chemical Characterization Parameters and MethodsAnalytical methods used in chemical characterization generally serve one of two purposes. screening samples for unspecified analytes and testing samples for specified (targeted) analytes. The purpose of a screening analysis is to reveal analytes present in the sample above a relevant reporting threshold (e.g., AET), to estimate the concentration of such analytes, and to secure the identities of such analytes. The purpose of a targeting analysis is to accurately and precisely establish the concentration of the specified (targeted) and identified analytes in the sample.7 Reporting of the Chemical Characterization DataThe purpose of a chemical assessment report is to provide information that enables the review of chemical characterization data and supports the toxicological risk assessment of this information. Types of information that can be included in a report to facilitate the toxicological risk assessment and the review of the analytical data and procedures are listed in Annex G. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of GB/T 16886.18-2022 be delivered?Answer: The full copy PDF of English version of GB/T 16886.18-2022 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of GB/T 16886.18-2022_English with my colleagues?Answer: Yes. 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