ДСТУ EN 16442:2018 Шкаф с контролируемыми условиями для хранения термочувствительных эндоскопов (EN 16442:2015, IDT)



ДСТУ EN 16442:2018
(EN 16442:2015, IDT)

Шафа з контрольованими умовами
для зберігання термочутливих ендоскопів

 
   
 
 
     
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 Performance requirements

4.1 General

4.2 Storage

4.3 Drying

4.4 Endoscope storage cabinet connectors (ESC connectors)

5 Mechanical and procedure requirem ents

5.1 Materials - design, manufacture and assembly

5.2 Air quality

5.3 Contam ination of the storage cabinet chamber surfaces

5.4 Drying process control

5.5 Endoscope channel aeration system

5.6 Automatic tern perature control

5.7 Fault indication/monitoring

5.8 Cycle indicators

5.9 Instruments and control devices

5.10 Tern perature indicators

5.11 Relative hum idity indicator

5.12 Pressure indicators

5.13 Traceability

5.14 Double-ended storage cabinets

6 Testing for conformity

6.1 General

6.2 Air changes

6.3 Overpressure

6.4 Drying

6.5 Contamination of the inside surfaces of the storage cabinet

6.6 Air quality

6.7 Channel aeration test

6.8 Therm om etric testing 1 - cham ber and load tern perature testing

6.9 Therm om etric test 2 - cham ber and load tern perature testing

6.10 Readability

6.11 Tests for air filtration

7 Documentation

8 Information to be supplied with the storage cabinet

8.1 General

8.2 Information to be supplied before delivery

8.3 Marking and labelling

8.4 Packaging

9 Information to be requested from the purchaser by the manufacturer

Annex A (informative) Summary of test programmes

Annex В (informative) Cross-contamination between endoscopes

Annex C (normative) Methods for evaluation of airborne microbial contamination in the storage cabinet

Annex D (informative) Procedure for parametric perform ance qualification

Annex E (normative) Internal residual contamination of endoscopes after storage

Annex F (normative) Establishing endoscope type test groups

Annex G (normative) Establishing endoscope product families

Bibliography