ДСТУ EN ISO 10993-18:2022 Биологическая оценка медицинских изделий. Часть 18. Химическая характеристика материалов медицинских изделий в процессе управления рисками (EN ISO 10993-18:2020, IDT; ISO 10993-18:20...



ДСТУ EN ISO 10993-18:2022
(EN ISO 10993-18:2020, IDT; ISO 10993-18:2020, IDT)

Біологічне оцінювання медичних виробів. Частина 18. Хімічна характеристика
матеріалів медичних виробів у процесі управління ризиками

 

 
   
 
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 Symbols and abbreviated terms

5 Characterization procedure

5.1 General

5.2 Establish medical device configuration and material composition

5.3 Assess material/chemical equivalence to a clinically established material or medical device

5.4 Assess the hypothetical worst-case chemical release based on total exposure to the medical device's chemical constituents

5.5 Establish an analytical evaluation threshold

5.6 Estimate the chemical release; perform extraction stud

5.7 Assess the estimated chemical release (extractables profile)

5.8 Determine the actual chemical release; perform leachables study

5.9 Assess the actual chemical release (leachables profile)

5.10 Exiting the chemical characterization process.......

6 Chemical characterization parameters and methods

6.1 General

6.2 Material composition

6.3 Extractables and leachables

6.4 Structural composition or configuration

6.5 Analytical methods

7 Reporting of the chemical characterization data

Annex A (informative) General principles of chemical characterization

Annex В (informative) Information sources for chemical characterization

Annex C (informative) Principles for establishing biological equivalence

Annex D (informative) Principles of sample extraction

Annex E (informative) Calculation and application of the analytical evaluation threshold (AET)

Annex F (informative) Qualification of analytical methods used for extractables/Ieachables

Annex G (informative) Reporting details for analytical methods and chemical data

Bibliography