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GB/T 16886.10-2017 English Version, GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization (English Version) - Code of China
Position: Chinese Standard in English/GB/T 16886.10-2017
GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization (English Version)
Standard No.: GB/T 16886.10-2017 Status: valid remind me the status change
Word Count: 27000 words Price(USD): 810.0 remind me the price change
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Detail of GB/T 16886.10-2017
Introduction of GB/T 16886.10-2017
Contents of GB/T 16886.10-2017
Standard No.: GB/T 16886.10-2017
English Name: Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization
Chinese Name: 医疗器械生物学评价 第10部分：刺激与皮肤致敏试验
Superseding: GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
Price(USD): 810.0
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 skin sensitization. This part includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; 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. In Annex B several special irritation tests are described for application of medical devices in areas other than skin. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 16886.1-2011	Biological Evaluation of Medical Devices - Evaluation and Testing Within a Risk Management Process (ISO 10993-1: 2009, IDT) ISO 10993-2	Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements ISO 10993-9	Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products) ISO 10993-12	Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials ISO 10993-13	(Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices) ISO 10993-14	Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products From Ceramics ISO 10993-15	Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys ISO 10993-18	Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials ISO 14155-1	Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirement ISO 14155-2	Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plants 3 Terms and Definitions For the purposes of this document, the terms and definitions given in GB/T 16886.1-2011 and the following apply. 3.1 allergen sensitizer substance or material that is capable of inducing a specific hypersensitivity reaction upon repeated contact with that substance or material 3.2 blank extraction vehicle not containing the test material, retained in a vessel identical to that which holds the test material and subjected to identical conditions to which the test material is subjected during its extraction Note: the purpose of the blank control is to evaluate possible confounding effects due to the extraction vessel, vehicle and extraction process. 3.3 challenge elicitation process following the induction phase, in which the immunological effects of subsequent exposures in an individual to the inducing material are examined 3.4 dose dosage amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area Note: the terms are often used interchangeably (more commonly dosage). 3.5 erythema reddening of the skin or mucous membrane 3.6 eschar scab or discolored slough of skin 3.7 extract liquid or suspension that results from exposing a test or control material to a solvent under controlled conditions 3.8 induction process that leads to the de novo generation of an enhanced state of immunological activity in an individual, to a specific material 3.9 irritant agent that produces irritation 3.10 irritation localized non-specific inflammatory response to single, repeated or continuous application of a substance/material Note: skin irritation is a reversible reaction and is mainly characterized by local erythema (redness) of the skin. 3.11 necrosis cell death as a direct result of irreversible changes caused by injury or disease Note: one should be aware that tissue repair will occur either resulting in complete functional restoration or resulting in scar formation.
Foreword	i Introduction	iv 1 Scope 2 Normative References 3 Terms and Definitions 4 General Principles - Step-Wise Approach 5 Pretest Considerations 6 Irritation Tests 7 Skin Sensitization Tests 8 Key Factors in Interpretation of Test Results Annex A (Normative) Preparation of Materials for Irritation/Sensitization Testing Annex B (Normative) Special Irritation Tests Annex C (Normative) Human Skin Irritation Test Annex D (informative) In Vitro Tests for Skin Irritation Annex E (Informative) Method for the Preparation of Extracts from Polymeric Test Materials Annex F (Informative) Background Information Bibliography
GB/T 16886.10-2017 is referred in:
Standard No. GB/T 16886.10-2017
Price(USD) 810.0
Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization
医疗器械生物学评价 第10部分：刺激与皮肤致敏试验
GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
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