ДСТУ EN 14180:2019 Стерилизаторы медицинские. Стерилизаторы низкотемпературные паровые и формальдегидные. Требования и испытания (EN 14180:2014, IDT)

ДСТУ EN 14180:2019
(EN 14180:2014, IDT)

Стерилізатори медичні. Стерилізатори низькотемпературні
парові та формальдегідні. Вимоги та випробування

 
   
 
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 Technical requirements

4.1 Sterilizer chamber

4.2 Design and construction

4.3 Indicating, measuring, operating and recording devices

5 Process control

5.1 General

5.2 Software verification and validation

5.3 Operating cycle and automatic control

5.4 Override of automatic control

5.5 Fault

6 Performance requirements

6.1 Sterilizing performance

6.2 Desorption efficacy

6.3 Drying

7 Sound power and vibration

8 Packaging, marking and labelling

9 Information to be supplied by the manufacturer

10 Service and local environment

10.1 General

10.2 Electricity

10.3 Sterilant

10.4 Steam

10.5 Water

10.6 Compressed air

10.7 Drainage and discharges

10.8 Ventilation and environment

10.9 Lighting

Annex A (normative) Test methids

Annex В (normative) Sterilizer classification and testing

Annex C (normative) Test equipment

Annex D (normative) Determination of formaldehyde residuals in a filter indicator

Annex E (informative) Formaldehyde residues on medical devices

Annex F (informative) Environmental aspects

Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of ELI Directive 93/42/EEC on medical devices

Bibliography