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.
GB/T 16886.10-2017 The following standards are cited：
GB/T 16886.10-2017 Cited by the following standards：
