ДСТУ EN ISO 10993-23:2022 Биологическая оценка медицинских изделий. Часть 23. Тесты на раздражение (EN ISO 10993-23:2021, IDT; ISO 10993-23:2021, IDT)

ДСТУ EN ISO 10993-23:2022
(EN ISO 10993-23:2021, IDT; ISO 10993-23:2021, IDT)

Біологічне оцінювання медичних виробів. Частина 23. Тести на подразнення

 
   
 
 
     
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General principles — Step-wise approach

5 Pre-test considerations

5.1 General

5.2 Types of material

5.3 Information on chemical composition

6 In vitro irritation tests

6.1 General

6.2 In vitro reconstructed human epidermis model

6.3 Materials

6.4 Methods

6.5 Considerations for test performance

6.6 Application of the test sample and rinsing

6.7 MTT test for determination of RhE tissue viability after the exposure period

6.8 Test acceptance criteria

6.9 Data calculation steps

6.10 Data interpretation — Prediction model

6.11 Method documentation sheet

6.12 Test report

7 In vivo irritation tests

7.1 General

7.2 Animal irritation test by skin exposure

7.3 Animal irritation test by intracutaneous (intradermal) administration

8 Human skin irritation test

8.1 Introduction

8.2 Initial considerations

Annex A (normative) Preparation of materials for irritation testing

Annex B (informative) Test method check list for in vitro irritation testing using reconstructed human epidermis models

Annex C (informative) Example of method documentation sheet for reconstructed human epidermis models

Annex D (normative) Special irritation tests

Annex E (normative) Human skin irritation test

Annex F (informative) Background information on irritation tests

Bibliography