ДСТУ EN ISO 13408-6:2022 Стерилизация изделий медицинского назначения. Часть 6. Системы изоляторов (EN ISO 13408-6:2021, IDT; ISO 13408-6:2021, IDT)

ДСТУ EN ISO 13408-6:2022
(EN ISO 13408-6:2021, IDT; ISO 13408-6:2021, IDT)

Стерилізація виробів медичного призначення.
Частина 6. Системи ізоляторів

 
   
 
 
     
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 Quality system elements

5 Basic principle of isolator systems

5.1 General

5.2 Negative pressure isolators

6 Isolator system specification

6.1 General

6.2 Risk management

6.3 User requirement specification

7 Design of isolator systems

7.1 General

7.2 Materials of construction

7.3 Air-handling system

7.4 Operator interface

7.5 Ancillary isolator equipment

7.6 Surrounding room classification

7.7 Process utilities

8 Validation

8.1 General

8.2 Design qualification

8.3 Installation qualification

8.4 Operational qualification

8.5 Performance qualification

8.6 Review and approval of validation

8.7 Requalification

9 Routine monitoring and control

9.1 Procedures

9.2 System integrity

9.3 Bio-decontamination process monitoring

9.4 Environmental monitoring

9.5 Change control

9.6 Maintenance and calibration

10 Personnel training

Annex A (informative) Devices acting as transfer ports for portable and mobile equipment

Annex B (informative) Isolator system — Explanation of terms used and flow of air and material

Annex C (informative) Isolator system — Direct/indirect product contact surfaces

Bibliography