ISO 10993-23:2021 Biological evaluation of medical devices —Part 23: Tests for irritation

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Biological evaluation of medical devices —

Part 23: Tests for irritation

1 Scope

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:

— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

— details of in vitro and in vivo irritation test procedures;

— key factors for the interpretation of the results.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

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 medical device materials within a risk management process

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

OECD 404, Acute Dermal Irritation/Corrosion

OECD 439, In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

3 Terms a nd definiti ons

For 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:

— ISO Online browsing platform: available at https:// www .iso. org/ obp

— IEC Electropedia: available at http:// www .electropedia .org/ 3.1

blank

solution prepared in the same way as the sample measuring solution but so that it does not contain the analyte to be determined

[SOURCE: ISO 10136-1:1993, 3.8, modified — the term has been changed from "blank test solution" to "blank".]

3.2

dose

dosage

amount of test sample (3.14) administered (e.g. mass, volume) expressed per unit of body weight or surface area

Note 1 to entry: The terms are often used interchangeably (more commonly dosage).

3.3

erythema

reddening of the skin or mucous membrane

3.4

eschar

scab or discoloured slough of skin

3.5

extract

liquid or suspension that results from exposing a test or control material to an extraction vehicle (3.16) under controlled conditions

3.6

irritant

agent that produces irritation (3.7)

3.7

irritation

localized non-specific inflammatory response to single, repeated or continuous application of a substance/material

Note 1 to entry: Skin irritation is a reversible reaction and is mainly characterized by local erythema (3.3) (redness) and swelling [oedema (3.9)] of the skin.

3.8

necrosis

cell death as a direct result of irreversible changes caused by injury or disease

Note 1 to entry: Tissue repair will occur either resulting in complete functional restoration or resulting in scar formation.

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