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GB/T 16886.12-2023: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials 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 16886.12: Historical versions
Similar standardsGB/T 16886.12-2023: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials---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/GBT16886.12-2023 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100.20 CCS C 30 GB/T 16886.12-2023 / ISO 10993-12.2021 Replacing GB/T 16886.12-2017 Biological Evaluation of Medical Devices – Part 12.Sample Preparation and Reference Materials (ISO 10993-12.2021, IDT) Issued on. NOVEMBER 27, 2023 Implemented on. DECEMBER 1, 2024 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 5 1 Scope... 8 2 Normative References... 8 3 Terms and Definitions... 8 4 General Requirements... 11 5 Reference Materials (RMs)... 12 5.1 General... 12 5.2 Certification of RMs for biological safety testing... 12 6 Use of RMs as Experimental Controls... 13 7 Test Sample Selection... 13 8 Test Sample and RM Preparation... 14 9 Selection of Representative Portions from a Medical Device... 14 10 Preparation of Extracts of Samples... 15 10.1 General... 15 10.2 Containers for extraction... 15 10.3 Extraction conditions and methods... 15 10.4 Extraction conditions for materials that polymerize in situ... 20 11 Records... 20 Annex A (Informative) Experimental Controls... 22 Annex B (Informative) General Principles on, and Practices of, Test Sample Preparation and Sample Selection... 23 Annex C (Informative) Principles of Test Sample Extraction... 25 Annex D (informative) Exhaustive Extraction of Polymeric Materials for Biological Evaluation... 28 Bibliography... 31ForewordThis 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 12 of GB/T (Z) 16886 Biological Evaluation of Medical Devices. GB/T (Z) 16886 consists of 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.Physio-chemical, morphological and topographical characterization of materials; --- Part 20.Principles and methods for immunotoxicology testing of medical devices; --- Part 22.Nanomaterials guide; --- Part 23.Tests for irritation. This Document replaced GB/T 16886.12-2017 Biological Evaluation of Medical Devices - Part 12.Sample Preparation and Reference Materials. Compared with GB/T 16886.12-2017, the major technical changes of this Documents are as follows besides the structural adjustments and editorial modifications. a) Change the "Scope" to cover only the extraction of biological evaluation tests (see Clause 1 of this Edition; Clause 1 of the 2017 Edition); b) Delete the terms and definitions of "accelerated extraction" and "simulated use extraction" (see 3.1 and 3.14 of the 2017 Edition); and change the definitions of "strict extraction", "extreme extraction", "extractables" and "leachable" (see 3.3, 3.4, 3.7 and 3.9 of this Edition; 3.4, 3.5, 3.8 and 3.10 of the 2017 Edition); c) Change the list items of extraction conditions (see 10.3.1 of this Edition; 10.3.1 of the 2017 Edition). This Document equivalently adopts ISO 10993-12.2021 Biological Evaluation of Medical Devices – Part 12.Sample Preparation and Reference Materials. 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 Medical Device and Drug Packaging Inspection Institute; and Sichuan University. Chief drafting staffs of this Document. Liang Jie, Sun Xiaoxia, Sun Lingxiao, Yuan Tun, and Qu Qiujin. The historical editions replaced by this Standard are as follows. --- GB/T 16886.12-2000 was first-time published in 2000; first-time revised in 2005; and second-time revised in 2017. --- It is third-time revised hereby.1 ScopeThis Document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following.2 Normative ReferencesThere are no normative references in this Document.3 Terms and DefinitionsFor the purposes of this Document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses. Substance that can be released from a medical device or material using either extraction solvents or extraction conditions, or both, that are expected to be at least as aggressive as the conditions of clinical use.4 General RequirementsWhen identifying hazards and estimating risk in relation to medical devices, hazards that arise from changes in the manufacturing process, or insufficient control of the manufacturing process, shall be considered in the design and preparation of test samples, as described in ISO 14971.5 Reference Materials (RMs)Certification of a RM is a procedure that establishes the numerical or qualitative value of the biological response of the material under the specified test conditions. This process serves to validate the testing of the material for that particular response and results in the issuance of a certificate.6 Use of RMs as Experimental ControlsRMs or CRMs shall be used in biological tests as control materials to demonstrate the suitability of a procedure to yield a reproducible response, i.e., positive or negative, or both. Any material used in this way shall be characterized with each biological test procedure for which the use of the material is desired.7 Test Sample SelectionTesting shall be performed on the final product, representative samples from the final product, materials processed in the same manner as the final product (see ISO 10993-1), or on appropriate extracts of any of these. The choice of test sample shall be justified.8 Test Sample and RM PreparationTest samples and RMs shall be handled with care to prevent contamination. Any residue from the manufacturing processes, intentional or unintentional additives or contaminants, shall be considered integral to the medical device, medical device portion or component, or representative sample.9 Selection of Representative Portions from a Medical DeviceWhen different materials are present in a single medical device, the potential for synergies and interactions shall be considered in the choice of test sample.10 Preparation of Extracts of SamplesThe extraction shall be performed in clean, chemically inert, closed containers with minimum dead space. In the case of products that polymerize in situ, the samples to be tested shall represent the intended clinical conditions of use in order to provide information on the potential toxicity of the reacting components in the polymer during the curing process.11 RecordsRecords of the sample and its preparation shall include, but not be limited to. ......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 16886.12-2023 be delivered?Answer: The full copy PDF of English version of GB/T 16886.12-2023 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 16886.12-2023_English with my colleagues?Answer: Yes. 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