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GB/T 16886.10-2024 English PDF (GB/T 16886.10-2017, GB/T 16886.10-2005)

GB/T 16886.10-2024_English: PDF (GB/T16886.10-2024)
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GB/T 16886.10-2024English740 Add to Cart 0--9 seconds. Auto-delivery Biological evaluation of medical devices - Part 10: Tests for skin sensitization Valid GB/T 16886.10-2024
GB/T 16886.10-2017English805 Add to Cart 0--9 seconds. Auto-delivery Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization Valid GB/T 16886.10-2017
GB/T 16886.10-2005English230 Add to Cart 0--9 seconds. Auto-delivery Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization Obsolete GB/T 16886.10-2005
GB/T 16886.10-2000EnglishRFQ ASK 4 days [Need to translate] Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization Obsolete GB/T 16886.10-2000


BASIC DATA
Standard ID GB/T 16886.10-2024 (GB/T16886.10-2024)
Description (Translated English) Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.100.20
Word Count Estimation 50,523
Date of Issue 2024-08-23
Date of Implementation 2025-09-01
Drafting Organization Shandong Medical Device and Drug Packaging Inspection Institute, Sichuan University, Jiangsu Medical Device Inspection Institute
Administrative Organization National Technical Committee for Standardization of Biological Evaluation of Medical Devices (SAC/TC 248)
Proposing organization State Drug Administration
Issuing agency(ies) State Administration for Market Regulation, National Standardization Administration

BASIC DATA
Standard ID GB/T 16886.10-2017 (GB/T16886.10-2017)
Description (Translated English) Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.100.20
Word Count Estimation 62,664
Date of Issue 2017-12-29
Date of Implementation 2018-07-01
Drafting Organization State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, Shenzhen Medical Device Testing Center
Administrative Organization National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC 248)
Proposing organization State Food and Drug Administration
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, China National Standardization Administration

BASIC DATA
Standard ID GB/T 16886.10-2005 (GB/T16886.10-2005)
Description (Translated English) Biological evaluation of medical devices. Part 10: Tests for irritation and sensitization
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040
Word Count Estimation 46,452
Date of Issue 2005-03-23
Date of Implementation 2005-12-01
Older Standard (superseded by this standard) GB/T 16886.10-2000
Quoted Standard GB/T 16886.1; GB/T 16886.2; GB/T 16886.9; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; ISO 10993-18; ISO 14155-1-2002; ISO 14155 - 2-2003
Adopted Standard ISO 10993-10-2002; IDT
Drafting Organization Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Administrative Organization Biological Evaluation of Medical Devices National Standardization Technical Committee
Regulation (derived from) Announcement of Newly Approved National Standards No. 6, 2005 (No. 80 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary This standard specifies: Medical devices and their constituent materials of potential irritation and delayed-type hypersensitivity evaluation steps.


GB/T 16886.10-2024 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100.20 CCS C 30 GB/T 16886.10-2024 / ISO 10993-10.2021 Replacing GB/T 16886.10-2017 Biological Evaluation of Medical Devices – Part 10.Tests for Skin Sensitization (ISO 10993-10.2021, IDT) ISSUED ON. AUGUST 23, 2024 IMPLEMENTED ON. SEPTEMBER 1, 2025 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of Contents Foreword... 5 Introduction... 7 1 Scope... 10 2 Normative References... 10 3 Terms and Definitions... 11 4 General Principles - Step-Wise Approach... 13 5 Pretest Considerations... 14 5.1 General... 14 5.2 Types of material... 14 5.2.1 Initial considerations... 14 5.2.2 Ceramics, metals and alloys... 14 5.2.3 Polymers... 14 5.2.4 Biologically derived materials... 15 5.3 Information on chemical composition... 15 5.3.1 General... 15 5.3.2 Existing data sources... 15 6 Skin Sensitization Tests... 16 6.1 Choice of test methods... 16 6.2 Murine local lymph node assay... 17 6.2.1 Principle... 17 6.2.2 Test sample preparation... 17 6.2.3 Animals and husbandry... 18 6.2.4 Test procedure... 18 6.2.5 Treatment groups... 19 6.2.6 Determination of cellular proliferation and tissue preparation... 20 6.2.7 Results and interpretation... 20 6.2.8 Test report... 21 6.3 Guinea pig assays for the detection of skin sensitization... 21 6.3.1 Principle... 21 6.3.2 Choice of test sample concentrations... 21 6.3.3 Induction... 22 6.3.4 Challenge... 22 6.4 Important factors affecting the outcome of the test... 22 6.5 Guinea pig maximization test... 23 6.5.1 Principle... 23 6.5.2 Test sample preparation... 23 6.5.3 Animals and husbandry... 24 6.5.4 Test procedure... 24 6.5.5 Observation of animals... 28 6.5.6 Evaluation of results... 28 6.5.7 Test report... 28 6.6 Closed-patch test (Buehler test)... 29 6.6.1 Principle... 29 6.6.2 Test sample preparation... 29 6.6.3 Animals and husbandry... 29 6.6.4 Test procedure... 29 6.6.5 Observation of animals... 31 6.6.6 Evaluation of results... 31 6.6.7 Test report... 31 7 Key Factors in Interpretation of Test Results... 32 Annex A (Normative) Preparation of Materials for Skin Sensitization Testing... 33 A.1 General... 33 A.2 Materials for direct-contact exposure... 33 A.2.1 Solid test materials... 33 A.2.2 Liquid test materials... 33 A.3 Extracts of test materials... 33 A.4 Solvents... 34 A.5 Sterile test materials... 34 Annex B (Informative) Method for the Preparation of Extracts from Polymeric Test Materials... 35 B.1 General... 35 B.2 Preparation method... 35 B.2.1 Preliminary extraction... 35 B.2.2 Final extraction... 35 B.3 Guinea pig maximization test... 37 B.3.1 General... 37 B.3.2 Challenge phase... 37 Annex C (Informative) Non-Animal Methods for Skin Sensitization... 38 C.1 Introduction... 38 C.1.1 Background on alternative methods for skin sensitization testing... 38 C.1.2 OECD’s adverse outcome pathway for skin sensitization... 38 C.1.3 Integrated approaches to testing and assessment... 40 C.2 In vitro assays for skin sensitization testing... 41 C.2.1 General... 41 C.2.2 Test methods... 41 C.3 Discussion... 49 C.3.1 OECD-validated assays... 49 C.3.2 Genomic assays... 50 C.3.3 Other assays... 50 C.3.4 General considerations for validation of in vitro methods for medical device testing ... 50 C.4 Conclusions... 51 Annex D (Informative) Background Information on Sensitization Tests for Skin Sensitization... 52 Bibliography... 56 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 Document is Part 10 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 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 Biological Evaluation of Medical Devices – Part 10.Tests for Skin Sensitization 1 Scope This Document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This Document includes. — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE. Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A. 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 testing within a risk management process (ISO 10993-1.2018, IDT) ISO 10993-2 Biological evaluation of medical devices – Part 2.Animal Welfare requirements NOTE. GB/T 16886.2-2011 Biological evaluation of medical devices – Part 2.Animal Welfare requirements (ISO 10993-2.2006, IDT) ISO 10993-12 Biological evaluation of medical devices – Part 12.Sample preparation and reference materials NOTE. GB/T 16886.12-2023 Biological evaluation of medical devices – Part 12.Sample There are two methods for preparing the test solution from the organic solvent extract. Method 1 is applicable when the amount of residue obtained by solvent extraction of a test sample and the weight of a test sample are relatively high because sufficient amounts of residue have been obtained. In addition, Method 1 is especially recommended to evaluate the risk for the medical devices which are repeatedly used. See Reference [14]. Method 2 is applicable when the amount of residue obtained by solvent extraction of a test sample or the weight of a test sample is relatively low. Examples of the latter are contact lenses and intraocular lenses. For both Methods 1 and 2, in parallel to the extraction of the test sample, the amount of solvent equal to the total volume used during the extraction of the test sample is subjected to the same concentration procedure as the test extracts. This solvent blank is used as negative control for each phase of testing. B.2.2.2 Test sample preparation according to Method 1 For Method 1, the extraction is performed by covering the test sample with a 10- to 20-fold volume of the appropriate solvent (as determined in the preliminary extraction test) and agitating (shaking) at room temperature. The solvent is collected in another flask. The solvent is exchanged three times [e.g. after extraction for (4 ± 1) h, (8 ± 1) h or (24 ± 2) h] and repeated to agitate at room temperature within a 24 h to 72 h period depending on the leaching and stability of the substances extracted from the test material. A residue is obtained by evaporating the collected solvent. A rotary evaporator is used at the lowest possible temperature that provides controlled evaporation under reduced pressure. The residue is dissolved in an appropriate vehicle (olive oil/acetone/ethanol/DMSO) as determined by the solubility experiment in the preliminary extraction test, to prepare a mass fraction of mass fraction of 10 % test solution for the intradermal induction phase and a mass fraction of 20 % test solution for the intradermal induction phase and for the topical induction phase in the GPMT. For the challenge phase in the GPMT, a mass fraction of 10 % solution is prepared in the vehicle. The 10 % solution is further diluted with the vehicle to obtain 1 %, 0.1 %, 0.01 % and 0.001 % test solutions. B.2.2.3 Test sample preparation according to Method 2 For Method 2, the extraction is performed by covering the test sample with a 10- to 20-fold volume of the appropriate solvent (as determined in the preliminary extraction test) and shaking at room temperature for (24 ± 2) h. The solvent is collected in one flask. The extraction procedure is repeated three times within a 24 h to 72 h period using the same volume of fresh solvent each time. The extracts are pooled in one flask and the solvent is evaporated. ......


GB/T 16886.10-2017 Biological evaluation of medical devices-Part 10. Tests for irritation and skin sensitization ICS 11.100.20 C30 National Standards of People's Republic of China Replace GB/T 16886.10-2005 Medical device biology evaluation Part 10. Stimulation and skin sensitization test (ISO 10993-10.2010, IDT) Released on.2017-12-29 2018-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration issued Foreword GB/T 16886 "Biological Evaluation of Medical Devices" consists of the following components. --- Part 1. Evaluation and testing in the risk management process; --- Part 2. Animal welfare requirements; --- Part 3. Genotoxicity, carcinogenicity and reproductive toxicity test; --- Part 4. Test options for interaction with blood; ---Part 5. In vitro cytotoxicity test; --- Part 6. Post-implantation local reaction test; ---Part 7. Ethylene oxide sterilization residue; ---Part 9. Qualitative and quantitative frameworks for potential degradation products; --- Part 10. Stimulation and skin sensitization test; --- Part 11. Systemic toxicity test; --- Part 12. Sample preparation and reference materials; --- Part 13. Qualitative and quantitative determination of degradation products of polymer medical devices; --- Part 14. Qualitative and quantitative determination of ceramic degradation products; ---Part 15. Qualitative and quantitative determination of metal and alloy degradation products; ---Part 16. Design of toxicokinetic studies of degradation products and leachables; --- Part 17. The establishment of a leachable allowable limit; ---Part 18. Chemical characterization of materials; ---Part 19. Physical chemistry, morphological and surface characterization of materials; --- Part 20. Principles and methods for immunological toxicology testing of medical devices. This part is the 10th part of GB/T 16886. Other aspects of biological testing will have other parts of the standard. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB/T 16886.10-2005 "Medical Device Biological Evaluation Part 10 Stimulation and delayed type hypersensitivity test Inspection, compared with GB/T 16886.10-2005, the main technical changes are as follows. --- Modified the standard name; ---Modified terms and definitions (Chapter 3, Chapter 3 of the.2005 edition); --- Cancellation of "material identification" (see 5.4 of.2005 edition); --- The intradermal reaction test was adjusted from the appendix to the text (see 6.4, Appendix B of the.2005 edition); --- Human skin irritation test method is adjusted from the text to the appendix (see Appendix C,.2005 edition 6.4); --- Skin sensitization test increases the local lymph node test in mice (see 7.2); --- Increased in vitro skin irritation test (see Appendix D); --- Added method for preparing polymer test material extract (see Appendix E). This section uses the translation method equivalent to ISO 10993-10.2010 "Medical Device Biology Evaluation Part 10. Stimulation and Skin Sensitive test. The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2. Animal welfare requirements (ISO 10993-2..2006, IDT) GB/T 16886.9-2017 Biological evaluation of medical devices - Part 9. Qualitative and quantitative framework for potential degradation products (ISO 10993-9.2009, IDT) GB/T 16886.12-2017 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (ISO 10993-12. 2012, IDT) GB/T 16886.13-2017 Biological evaluation of medical devices - Part 13. Qualitative analysis of degradation products of polymer medical devices Quantification (ISO 10993-13.2010, IDT) GB/T 16886.14-2003 Biological evaluation of medical devices - Part 14. Qualification and quantification of ceramic degradation products (ISO 10993-14.2001, IDT) GB/T 16886.15-2003 Biological evaluation of medical devices - Part 15. Qualification and quantification of degradation products of metals and alloys (ISO 10993-15.2000, IDT) GB/T 16886.18-2011 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005, IDT) This part is proposed by the State Food and Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248). This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center; Shenzhen Medical Device Testing Center. The main drafters of this section. Wang Wei, Cao Ping, Fan Chunguang, Liu Wei, Xu Wei District. The previous versions of the standards replaced by this section are. ---GB/T 16886.10-2000; ---GB/T 16886.10-2005. introduction This part of GB/T 16886 is used to assess the exposure hazards that may be caused by chemicals released from medical devices, including Skin and mucous membrane irritation, eye irritation or skin sensitization. Certain materials contained in medical devices have been tested and their potential skin, mucous membrane irritation or sensitization has been confirmed. other Some untested materials and their chemical composition may have adverse effects when in contact with human tissue. Therefore, the manufacturer is responsible Evaluate the potential adverse effects of the device before it is placed on the market. Traditionally, small animal experiments have to be carried out before human trials to help predict human response. Recently, it has also been added as an auxiliary or Optional in vitro and human trials. Although much effort has been made in this area and some progress has been made, the results show The previously designed in vitro tests have not been satisfactory, so it has not been possible to eliminate the in vivo test. When appropriate, this section encourages in vitro pre-testing The method was used as a screening test before animal testing. In order to reduce the number of animals used, this section proposes a step-by-step evaluation method, which is tested at each stage. The results are reviewed and analyzed. Animal testing is generally required prior to human testing. These studies should be conducted in accordance with good laboratory quality management practices and in compliance with animal welfare regulations. Suggested in the right circumstances Statistical analysis of the data. This section is used by trained and experienced professionals who are able to interpret the standard requirements and consider all aspects of the device. The factors, including the intended use of the device, the current knowledge of the medical device given by the review of the scientific literature and prior clinical experience, Determine the evaluation results of each medical device. The tests included in this section are important tools for the development of safety products and are tested by trained personnel and explain the test results. This section is based on a number of standards and guidelines, including OECD guidelines, the United States Pharmacopoeia and the European Pharmacopoeia. This section can be used as a basic text. Used to select and implement tests that evaluate stimuli and skin sensitization reactions associated with the safety of medical materials and devices. Medical device biology evaluation Part 10. Stimulation and skin sensitization test 1 Scope This part of GB/T 16886 describes the evaluation steps for potential stimulation and skin sensitization of medical devices and their constituent materials. This section includes. a) pre-stimulation considerations, including bio-simulation experiments and in vitro methods for skin contact; b) detailed in vivo (stimulation and sensitization) test procedures; c) Key factors for interpretation of the results. Appendix A gives specific material preparation instructions related to the above tests. Appendix B gives the skin removal unit for medical devices. Several special stimulation tests outside the position. 2 Normative references The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (ISO 10993- 1.2009, IDT) ISO 10993-2 Medical Device Biology Evaluation Part 2. Animal welfare requirements (Biologicalevaluationofmedical devices-Part 2.Animalwelfarerequirements) ISO 10993-9 Biological evaluation of medical devices - Part 9. Qualitative and quantitative framework for potential degradation products (Biologicaleval- uationofmedicaldevices-Part 9. Frameworkforidentificationandquantificationofpotentialdegra- Dationproducts) ISO 10993-12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (Biologicalevaluationof medicaldevices-Part 12. Samplepreparationandreferencematerials) ISO 10993-13 Biological evaluation of medical devices - Part 13. Qualification and quantification of degradation products of polymer medical devices (Bi- OLOGICALevaluationof medicaldevices-Part 13.Identificationandquantificationofdegradation Productsfrompolymericmedicaldevices) ISO 10993-14 Biological evaluation of medical devices - Part 14. Qualification and quantification of ceramic degradation products (Biologicalevalua- tionofmedicaldevices-Part 14.Identificationandquantificationofdegradationproductsfromceram- Ics) ISO 10993-15 Biological evaluation of medical devices - Part 15. Qualification and quantification of metal and alloy degradation products (Biological evaluationofmedicaldevices-Part 15.Identificationandquantificationofdegradationproductsfrom Metalsandaloys) ISO 10993-18 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (Biologicalevaluationofmedical devices-Part 18.Chemical characterizationofmaterials) ISO 14155-1 Clinical investigation of medical devices for human body Part 1. General requirements (ClinicalInvestigation ofMed- icalDevicesforHumanSubjects-Part 1.GeneralRequirement) ISO 14155-2 Clinical studies of medical devices for humans - Part 2. Clinical research medicaldevicesforhumansubjects-Part 2.Clinicalinvestigationplants) 3 Terms and definitions The following terms and definitions as defined in GB/T 16886.1-2011 apply to this document. 3.1 Allergen aergen Allergen sensitizer A substance or material that causes a specific type of hypersensitivity reaction after repeated exposure. 3.2 Blank blank The leaching medium without the test material was placed in the same vessel as the test material and subjected to the same leaching conditions as the test material. Note. The purpose of the blank control is to evaluate the possible interference effects of the leaching vessel, the leaching medium and the leaching process. 3.3 Stimulate chalenge Elicitation elicitation The process after the induction phase, at which the individual's subsequent exposure to the immunological response of the inducing material is examined. 3.4 Dose dose Dosage The amount of test sample (eg, mass, volume) expressed in terms of unit weight or surface area. Note. These two terms are usually used interchangeably (used more commonly). 3.5 Erythema erythema Redness of the skin or mucous membranes. 3.6 Jiao eschar Scarring or discolored skin. 3.7 Extract extract A liquid or suspension obtained after contact of a test material or control material with a solvent under controlled conditions. 3.8 Induction induction A process that results in an individual's re-establishment of an immunologically active state of a particular material. 3.9 Irritant irritant a substance that causes irritation. 3.10 Stimulate irritation A local, non-specific inflammatory response caused by one, multiple, or continuous contact with a substance/material. Note. Skin irritation is a reversible reaction characterized by local erythema (redness) in the skin. 3.11 Necrosis necrosis Irreversible changes due to injury or disease directly lead to cell death. Note. It should be noted that tissue repair can lead to complete functional recovery or scar formation. 3.12 Negative control negativecontrol Appropriate negative, non-reactive or most reproducible in the test system to demonstrate the suitability of the test procedure when tested in accordance with the prescribed procedure A sufficiently characterized material or substance that is small in response. Note. In practice, negative controls include blanks, media/solvents, and reference materials. 3.13 Edema oedema Swelling caused by abnormal penetration of liquid into the tissue. 3.14 Positive control Appropriate positives or reactions that reproduce the suitability of the test procedure in the test system when evaluated according to the specified test method A well characterized material or substance that is sexually responsive. 3.15 Skin corrosion skincorrosion The irreversible damage of the skin after application of a test sample is manifested by significant necrosis from the epidermis to the dermis. Example. Skin ulcers caused by the action of a mixture/chemical/test sample (see 3.19). 3.16 Skin sensitization skinsensitization Allergic contact dermatitis Immune-mediated skin response to a substance. Note. This reaction is characterized by itching, erythema, edema, papules, large (small) blisters, or such syndromes in the human body. Other species may behave differently, only There are erythema and edema. 3.17 Test material testmaterial Sampling materials, instruments, parts of a device or components thereof for biological or chemical testing. 3.18 Test sample testsample A material, device, part of a device, component, leachate or part of a leachate for biological or chemical testing or evaluation. 3.19 Ulcer ulceration It is characterized by open ulceration of superficial tissue defects. 3.20 Media vehicle A liquid used to wet, dilute, suspend, leach, or dissolve test materials/materials. 4 Basic Principles - Step by Step Evaluation Existing test methods for testing stimuli and sensitization are specifically designed to measure potential skin irritation and mucosal irritation as well as skin sensitization These tests generally do not predict other types of adverse effects. Intradermal injection test for implanted medical devices or externally connected medical devices It is closer to the actual application, so it is used to test the stimulating effect and should be tested intradermally as described in 6.4. This section requires a step-by-step evaluation method that should include one or more of the following. a) in accordance with the basic principles of ISO 10993-9, ISO 10993-13, ISO 10993-14, ISO 10993-15 and ISO 10993-18, Characterizing the test material involves chemical characterization and analysis of the test sample; b) Literature search, including evaluation of the chemical and physical properties of the test materials, any product components and related structures of chemicals and materials Potential stimulation and sensitization information; c) In accordance with ISO 10993-2, it should be considered that in vitro testing takes precedence over in vivo testing, if the new in vitro method is scientifically recognized and reasonable And practicality, can replace the in vivo test. There are in vitro alternative methods for the evaluation of chemical skin irritation and corrosion, currently In vitro testing of sensitizers that have not been internationally recognized and accepted; d) In vivo animal testing. In order to ensure the reproducibility and sensitivity of the test, the testing laboratory should include in each stimulation and sensitization test. A positive control was tested to verify the test system and confirm a positive response. However, for the guinea pig sensitization test, when the test system is When the sex is confirmed for 6 months or longer, it is not necessary to include a positive control in each test, but at regular intervals. (not more than 6 months) to conduct a positive control test; Note 1. The current sensitization can only be determined by in vivo tests, using mouse local lymph node test (LLNA), guinea pig closure test or porpoise Rat Maximum Dose Test (GPMT). LLNA is currently the preferred method for determining the potential sensitization of a single chemical, see references [69], [88], [90]. Note 2. In vivo animal testing is applicable when the test material cannot be characterized or the information obtained in stages a), b) and c) cannot be assessed for risk. Note 3. For the guinea pig sensitization test, 10 animals are generally used for the positive control every 6 months. Positive in more frequent times than every 6 months When the control substance is tested, fewer guinea pigs may be used, and at least 5 test animals should be used for the positive substance and 5 control animals. e) Non-invasive human trials/clinical trials. if the material has been shown to be non-irritating, non-sensitizing or non-toxic to the animal, consider the human body Skin irritation studies. Before the other evaluation results in a)~d) are known, the ISO 14155-1 and ISO 14155-2 and ethical guidelines should not be followed. Bed test. 5 pre-test considerations 5.1 General It is important to emphasize that pre-test considerations are very important and can lead to conclusions that do not require stimulation and/or sensitization testing. The requirements given in Chapter 5 of GB/T 16886.1-2011 and the following clauses apply. Non-sterile samples should only be studied by local testing because the possibility of microbial contamination of the test sample interferes with the interpretation of the final test. Intradermal testing may be demonstrated for test samples that do not guarantee sterility but are still considered to be non-contaminating. 5.2 Material Type 5.2.1 Basic considerations Other chemical components that may be used as processing aids (such as lubricants or mold release agents) during the manufacture and assembly of medical devices should be considered. apart from In addition to the chemical composition of raw materials and manufacturing processing aids, assembly of binders/solvent residues and sterilization residues or reactions due to sterilization processes Sex products may be present in the final product, and whether these ingredients pose a health hazard (risk) depends on the leakage or degradation properties of the final product. Consider the potential stimulatory/sensitizing activity of these ingredients. 5.2.2 Ceramics, metals and alloys These materials are generally simpler in terms of chemical composition than polymers and biologically derived materials. 5.2.3 Polymer Such materials are generally more complex in chemical composition than in 5.2.2, and may have several reactive products/impurities/additives, and The degree of completeness of the polymerization may vary. 5.2.4 Biologically derived materials Such materials are particularly complex in their composition and often contain processing residues such as crosslinkers and antibiotics. Between biological material samples The ingredients may be inconsistent. The methods in this section are not designed to test biologically derived materials and are therefore not sufficient to test such materials, such as the tests in this section. Cross-species sensitization was not considered. 5.3 Information on chemical composition 5.3.1 General Complete qualitative data on the chemical composition of the material should be established, as well as information and quantitative data related to biosafety. Such as There is no quantitative data indicating that documents should be documented and demonstrated. 5.3.2 Existing data sources Where possible, qualitative and quantitative information on chemical composition should be obtained from the raw material supplier. Polymers often require the right to use patent information and should sign the terms of the transfer and use of such confidential information. It should also be requested from any suitable member of the manufacturing chain of the product manufacturing (including semi-finished and part manufacturers) for any other production process. Qualitative information for additives such as mold release agents. In the absence of any chemical composition data, it is recommended to study the literature to determine the approximate characteristics of raw materials and additives, which helps Choose the most appropriate analytical method for the relevant material. The chemical composition of the final product shall be determined in accordance with ISO 10993-18. Note. The composition of ceramics, metals and alloys may be specified in accordance with ISO or American Society for Testing and Materials (ASTM) standards and/or user requirements, but in order to obtain Qualitative and quantitative information on the entire composition, may also require the raw material supplier or manufacturer and the parts manufacturer to provide this information to ensure Identify processing aids. Another source of access to this data is the material documents that the administration controls. 6 stimulation test 6.1 In vitro stimulation test In vitro tests, namely rat skin transcutaneous electrical impedance (TER) test and human skin model test, have been internationally recognized and accepted as evaluations. Alternative test for valence chemical skin corrosion (OECD Guideline 430 [9] and 431 [10]). While studying alternative methods, international And national organizations have been conducting the establishment and validation of in vitro skin irritation tests, and some groups are studying experimental methods for animals and Quantitative indicators of human response to better define endpoints using non-invasive techniques (see F.1). Note. The European Alternatives Validation Center Advisory Committee (ESAC).2007 is an in vitro human skin model for the determination of chemical skin irritation. The identification process was evaluated, see reference [101]. Appendix D describes the potential for applying an in vitro human body model to assess the effects of chemicals on skin irritation. At present, the in vitro skin irritation test is only confirmed for purification of the material, and is not suitable for the medical device extract. In order to apply these methods to verify The stimulating potential of medical devices is necessary to further confirm this specific application. 6.2 In vivo stimulation test - factors to be considered in in vivo test design and selection Stimulation tests for medical devices can be performed with the final product and/or the extract. Factors affecting the results of the stimulus test include. a) the characteristics of the device used in the patch test; b) the dose of the test material; c) the application method of the test materials; d) the extent of closure; e) application site; f) contact cycle and number of contacts; g) Evaluate the technology used in the trial. Additional background information is provided in Appendix F. The flexibility of the following detailed protocols sometimes allows researchers to increase the sensitivity of the test to suit various uses and crowd contact strips. Pieces, but the consistency of the test procedures is conducive to the comparability of test results from different materials and different laboratories. Requirements for evaluating multiple and/or long-term exposure to instruments and materials are included in the test procedure and the test design should be higher than expected. Bed contact conditions (time and/or concentration) should be noted when interpreting the test results. The pH of the test sample, such as ≤ 2.0 or ≥ 11.5, should be considered an irritant and no further testing is required. However, the test results are also obvious It is shown that the pH of the test material is not the only factor that causes severe damage, the concentration of the test material, the contact time, and many of its His physical and chemical properties are also important factors. Further risk characterization/assessment is required in special cases and it may be necessary to test the irritancy of the material or the pH of the material in the above range In addition, this situation should be demonstrated and documented. 6.3 Animal stimulation test 6.3.1 Principle Relevant animal models were used to assess the potential of the material to produce a skin irritation response under the test conditions. Rabbits are the preferred test animals. 6.3.2 Test materials Solid or liquid test materials shall be prepared in accordance with Appendix A. The sensitivity of the test should be demonstrated by a set of positive controls in the test. However, using a positive control to confirm Sensitivity is limited to cases where the laboratory did not produce a positive result within the previous 6 months. Note. Sodium lauryl sulfate (SLS) is a suitable positive control. 6.3.3 Animals and management Three healthy, adult albino rabbits should be used, male or female, the same strain, weighing no less than 2kg. As expected, there is a stimulating reaction, initially Try to consider using 1 animal. Unless there is a clear positive reaction [erythema or edema score greater than 2 (see Table 1)], at least The test was carried out with 2 animals. After using at least 3 animals, if it is a suspected reaction, a retest should be considered. Animals should be adapted to the environment and kept in accordance with ISO 10993-2. 6.3.4 Test procedure 6.3.4.1 Animal preparation The skin condition of the animal is a key factor in the test and only animals with healthy skin and no damage can be used. Generally before the test 4h~24h A sufficient area of hair (approximately 10 cm x 15 cm area) was removed on both sides of the animal's dorsal spine for use as test and observation sites. For the sake of convenience Check and/or retest, may need to repeatedly remove hair. If the testing agency confirms the use of the depilatory agent, it can be used by professionals. Hair removal. If repeated contact is required, follow the steps 6.3.4.2.1, 6.3.4.2.2 or 6.3.4.2.3 below for a maximum of 21 days. 6.3.4.2 Application of test samples 6.3.4.2.1 Application of powder or liquid samples 0.5 g or 0.5 mL of test material was placed directly on the skin site shown in Figure 1. Solid and hydrophobic materials do not require wetting, powder The agent should be slightly humidified with water or ot...... ......


GB/T 16886.10-2005 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 30 GB/T 16886.10-2005 / ISO 10993-10.2002 Replacing GB/T 16886.10-2000 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity (ISO 10993-10.2002, IDT) ISSUED ON. MARCH 23, 2005 IMPLEMENTED ON. DECEMBER 1, 2005 Issued by. General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China; Standardization Administration of the People’s Republic of China. 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes. Table of Contents Foreword ... 3 Introduction ... 5 1 Scope ... 6 2 Normative references ... 6 3 Terms and definitions ... 7 4 General principles and evaluation procedure ... 10 5 Pretest considerations ... 11 6 Irritation tests ... 13 7 Delayed hypersensitivity tests ... 25 8 Key factors in interpretation of test results ... 33 Annex A (normative) Preparation of materials for irritation and sensitization testing ... 35 A.1 General ... 35 A.2 Materials for direct-contact exposure ... 35 A.3 Extracts of test materials... 36 A.4 Solvents ... 36 A.5 Sterile test materials ... 36 Annex B (informative) Additional irritation tests ... 37 B.1 General ... 37 B.2 lntracutaneous reactivity test ... 37 B.3 Ocular irritation test ... 40 B.4 Oral mucosa irritation test ... 45 B.5 Penile irritation test ... 49 B.6 Rectal irritation test ... 52 B.7 Vaginal irritation test ... 54 Annex C (informative) Background information ... 58 C.1 Background information on irritation tests ... 58 C.2 Background information on sensitization tests for delayed hypersensitivity 59 Bibliography ... 63 Foreword This Part of GB/T 16886 is identical to the international standard ISO 10993-10.2002 “Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity”. This Part replaces GB/T 16886.10-2000, which has been technically revised. The main revised contents are as follows. - MODIFY “General principles and evaluation procedure”; - ADD “Pretest considerations”; - ADD “Irritation tests on human skin”; - MODIFY “Delayed hypersensitivity tests”; - PLACE “lntracutaneous reactivity test” and “Ocular irritation test”, which are in the main body of the original standard, IN annex B, as the applicable irritation tests for medical devices for specific portion; - MODIFY the contents of annexes A and B of the original standard, the heading is “Preparation of materials for irritation/sensitization testing”; - MODIFY “Background information”; - CANCEL annex C of the original standard. GB/T 16886 consists of the following parts, under the general title “Biological evaluation of medical devices”. - Part 1. Evaluation and testing; - 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 8. Selection and qualification of reference materials for biological tests; - Part 9. Framework for identification and quantification of potential degradation products; - Part 10. Tests for irritation and delayed-type hypersensitivity; - 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 leachables; - Part 17. Establishment of allowable limits for leachable substances; - Part 18. Chemical characterization of materials. Future parts will deal with other relevant aspects of biological testing. This Part is a harmonization of numerous standards and guidelines, including BS 5736, OECD Guidelines, U.S. Pharmacopoeia and the European Pharmacopoeia. This Part is the basic document for the selection and conduct of tests enabling evaluation of irritation and dermal sensitization responses relevant to safety of medical materials and devices. Annex A is normative, and Annexes B and C are informative. This Part is proposed by State Food and Drug Administration. This Part is under the jurisdiction of National Technical Committee on Biological Evaluation of Medical Devices of Standardization of China. Drafting organization of this Part. State Food and Drug Administration - Jinan Quality Supervision and Inspection Centre for Medical Devices. Main drafters of this Part. You Shaohua, Qian Chengyu, Zhu Xuetao, Huang Jingchun, Wang Xin, Wang Kelei. Introduction This Part assesses possible contact hazards from chemicals released from medical devices that may produce skin and mucosal irritation, eye irritation and delayed contact hypersensitivity Some materials that are included in medical devices have been tested, and their skin or mucosal irritation or sensitization potential has been documented. Other materials and their chemical components have not been tested and may induce adverse effects when in contact with biological tissues. The manufacturer is thus obliged to evaluate each device for potential adverse effects prior to marketing. Traditionally, small animal tests are performed prior to testing on humans to help predict human response. More recently, in vitro tests as well as human tests have been added as alternatives. Despite progress and considerable effort in this direction, a review of findings suggests that currently no satisfactory in vitro test has been devised to eliminate the requirement for in vivo testing. Where appropriate, the preliminary use of in vitro methods is encouraged for screening purposes prior to animal testing. In order to reduce the number of animals used, this Part presents a step-wise approach, with review and analysis of test results at each stage. An animal test is usually required prior to human testing. It is intended that these studies be conducted using Good Laboratory Practice and comply with regulations related to animal welfare. Statistical analysis of data is recommended and should be used whenever appropriate. The tests included in this Part of GB/T 16886 are important tools for the development of safe products, provided that these are executed and interpreted by trained personnel. Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity 1 Scope This Part of GB/T 16886 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This Part of GB/T 16886 includes a) pretest considerations, b) details of the test procedures, and c) key factors for the interpretation of the results. Instructions are given in annex A for the preparation of materials specifically in relation to the above tests. Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B. 2 Normative references The following normative documents contain provisions which, through reference in this t... ......

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