ДСТУ EN ISO 10993-7:2015 Биологическое оценивание медицинских изделий. Часть 7. Остатки после стерилизации этиленоксидом (EN ISO 10993-7:2008, IDT)

ДСТУ EN ISO 10993-7:2015
(EN ISO 10993-7:2008, IDT)

Біологічне оцінювання медичних виробів.
Частина 7. Залишки після стерилізації етиленоксидом

 
   
 
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 Requirements

4.1 General

4.2 Categorization of devices

4.3 Allowable limits

4.4 Determination of EO and ECH residuals

5 Product release

5.1 General

5.2 Release of products without dissipation curve data

5.3 Procedure for product release using residue dissipation curves

Annex A (normative) Evaluation of gas chromatograms

Annex В (informative) Gas chromatographic determination for EO and ECH

Annex C (informative) Flowchart and guidance for the application of this part of ISO 10993 series of standards to the determination of EO and ECH residuals in medical devices

Annex D (informative) Factors influencing product residual

Annex E (informative) Extraction conditions for determination of residual EO

Annex F (informative) Rationale for the provisions of this part of ISO 10993

Annex G (informative) Establishment of allowable limits for EO

Annex H (informative) Establishment of allowable limits for ECH

Annex I (informative) Establishment of allowable limits for EG

Annex J (informative) Preparation of EO and ECH standards

Annex К (informative) Ethylene oxide residue measuring methods

Bibliography