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GB/T 16886.23-2023: Biological evaluation of medical devices - Part 23: Tests for irritation Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsGB/T 16886.23-2023: Biological evaluation of medical devices - Part 23: Tests for irritation---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/GBT16886.23-2023GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100.20 CCS C 30 GB/T 16886.23-2023 / ISO 10993-23.2021 Biological Evaluation of Medical Devices – Part 23.Tests for Irritation (ISO 10993-23.2021, 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... 5 Introduction... 7 1 Scope... 11 2 Normative References... 11 3 Terms and Definitions... 12 4 General Principles - Step-Wise Approach... 15 5 Pre-Test Considerations... 16 5.1 General... 16 5.2 Types of material... 16 5.2.1 Initial considerations... 16 5.2.2 Ceramics, metals and alloys... 17 5.2.3 Polymers... 17 5.2.4 Biologically derived materials... 17 5.3 Information on chemical composition... 17 5.3.1 General... 17 5.3.2 Existing data sources... 17 6 In Vitro Irritation Tests... 18 6.1 General... 18 6.2 In vitro reconstructed human epidermis model... 18 6.2.1 Test system - Reconstructed human epidermis model... 18 6.2.2 Principle of the method... 19 6.2.3 Prediction model... 20 6.3 Materials... 20 6.3.1 Reconstructed human epidermis models - Product description... 20 6.3.2 Preparation of medical device extracts... 21 6.4 Methods... 22 6.4.1 General... 22 6.4.2 Test procedure... 22 6.4.3 Media and end point solutions... 24 6.4.4 Test sample and control preparation... 24 6.5 Considerations for test performance... 25 6.5.1 Receipt of the reconstructed human epidermis tissues... 25 6.5.2 Preparation and pre-incubation... 25 6.6 Application of the test sample and rinsing... 26 6.6.1 General... 26 6.6.2 Preparation... 26 6.6.3 Test extract and controls exposure... 26 6.7 MTT test for determination of RhE tissue viability after the exposure period... 27 6.7.1 MTT incubation and isopropanol extraction... 27 6.7.2 Absorbance measurements... 28 6.8 Test acceptance criteria... 29 6.9 Data calculation steps... 29 6.9.1 General... 29 6.9.2 Isopropanol background control for OD in RhE assay... 29 6.9.3 Negative DPBS or PBS treated controls... 29 6.9.4 Positive control... 30 6.9.5 Tested extract and VC samples (TTs)... 30 6.10 Data interpretation - Prediction model... 30 6.11 Method documentation sheet... 31 7 In Vivo Irritation Tests... 32 7.1 General... 32 7.2 Animal irritation test by skin exposure... 33 7.2.1 Principle... 33 7.2.2 Test materials... 33 7.2.3 Animals and husbandry... 33 7.2.4 Test procedure... 33 7.2.5 Observation of animals... 35 7.2.6 Evaluation of results... 36 7.2.7 Test report... 38 7.3 Animal irritation test by intracutaneous (intradermal) administration... 38 7.3.1 Introduction... 38 7.3.2 Exclusion from test... 39 7.3.3 Test sample... 39 7.3.4 Animals and husbandry... 39 7.3.5 Test procedure... 39 7.3.6 Observation of animals... 40 7.3.7 Evaluation of results... 41 7.3.8 Test report... 41 8 Human Skin Irritation Test... 42 8.1 Introduction... 42 8.2 Initial considerations... 43 Annex A (Normative) Preparation of Materials for Irritation Testing... 44 Annex B (Informative) Test Method Check List for In Vitro Irritation Testing Using Reconstructed Human Epidermis Models... 46 Annex C (Informative) Example of Method Documentation Sheet for Reconstructed Human Epidermis Models... 48 Annex D (Normative) Special Irritation Tests... 53 Annex E (Normative) Human Skin Irritation Test... 73 Annex F (Informative) Background Information on Irritation Tests... 78 Bibliography... 80ForewordThis 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 23 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 equivalently adopted ISO 10993-23.2021 Biological Evaluation of Medical Devices – Part 23.Tests for Irritation. 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; National Institutes for Food and Drug Control; Beijing Institute of Medical Device Testing (Beijing Medical Biological Protection Equipment Inspection and Research Center). Chief drafting staffs of this Document. Fan Chunguang, Wang Guowei, Chen Liang, Wang Rui, Chen Liyuan, He Xueying, and Liu Xiangdong.1 ScopeThis Document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. This Document includes.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. GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1.Evaluation and testing within a risk management process (ISO 10993-1.2018, IDT)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. Liquid or suspension that results from exposing a test or control material to an extraction vehicle (3.16) under controlled conditions.4 General Principles - Step-Wise ApproachThe available methods for testing irritation were developed specifically to detect skin and mucous membrane irritation potential. Other types of adverse effects, such as sensitization, are generally not predicted by these tests. Historically irritation testing was done on rabbits.5 Pre-Test ConsiderationsIt shall be taken into consideration that during manufacture and assembly of medical devices, additional chemical components can be used as processing aids, for example, lubricants or mold-release agents. These materials are inherently complex in their composition. They often also contain process residues, for example, cross-linkers and anti-microbial agents. Biological materials can be inconsistent from sample to sample.6 In Vitro Irritation TestsThe RhE model shall consist of normal human-derived epidermal keratinocytes, which have been cultured to form a multi-layered highly differentiated model of the human epidermis.7 In Vivo Irritation TestsIrritation testing of either medical devices, components of medical devices or biomaterials, or all, can be performed with either the devices, device components, biomaterials themselves or extracts thereof, or all. An assessment is made of the potential of the material under test to produce dermal irritation in a suitable animal model. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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