ДСТУ EN 285:2019 Стерилізація. Стерилізатори парові. Стерилізатори великогабаритні (EN 285:2015, IDT)

ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ

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(ДП «УкрНДНЦ»))

Наказ від 12.12.2019 № 409

EN 285:2015

Sterilization — Steam sterilizers —
Large sterilizers

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN 285:2019
(EN 285:2015, IDT)

Стерилізація. Стерилізатори парові.
Стерилізатори великогабаритні

З наданням чинності від 2020–01–01

Contents

European foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Mechanical components

4.1 Dimensions

4.2 Materials

4.3 Pressure vessel

4.4 Framework and panelling

4.5 Loading equipment

4.6 Transport

5 Piping system and components

5.1 Pipework and fittings

5.2 Steam source

5.3 Air filter

5.4 Vacuum system

6 Measuring system, indicating and recording devices for temperature, pressure, time and status indicators

6.1 General

6.2 Measuring system

6.3 Status indicators

6.4 Measuring chains and time equipment

6.5 Recording systems

7 Control systems

7.1 General

7.2 Fault indication system

7.3 Software verification and validation

8 Performance requirements

8.1 Steam penetration

8.2 Physical parameters

8.3 Load dryness

9 Sound power and vibration

9.1 Sound power

9.2 Vibration

10 Rate of pressure change

11 Safety, risk control and usability

11.1 Protective measures

11.2 Risk control, usability

12 Packaging and marking

13 Service and working environment

13.1 General

13.2 Electrical supply

13.3 Steam supply to the sterilizer chamber

13.4 Lighting

13.5 Water, except water specified in 13.3.6

13.6 Compressed air

13.7 Electromagnetic interference

13.8 Drains

13.9 Working Environment

13.10 Service connections

14 Testing

14.1 General

14.2 Calibration

14.3 Environment

15 Hollow load test

15.1 General

15.2 Apparatus

15.3 Procedure

16 Thermometric tests

16.1 Small load, thermometric

16.2 Full load, thermometric

17 Bowie and Dick test

17.1 General

17.2 Apparatus

17.3 Procedure

18 Air leakage test

18.1 General

18.2 Apparatus

18.3 Procedure

19 Air detector tests

19.1 General

19.2 Air detector, small load

19.3 Air detector, full load

19.4 Air detector function

20 Load dryness test

20.1 Load dryness, small load, textiles

20.2 Load dryness, full load, textile

20.3 Load dryness, metal

21 Steam quality test

21.1 Non-condensable gases

21.2 Dryness

21.3 Superheat

21.4 Sampling of steam condensate

22 Rate of pressure change

22.1 General

22.2 Apparatus

22.3 Procedure

23 Test apparatus, equipment and material

23.1 Standard test pack

23.2 Reduced test

23.3 Test instruments

23.4 Full load, textiles

23.5 Test pack, metal

23.6 Metering device

24 Documentation to be supplied with the sterilizer

25 Information to be supplied with the sterilizer

Annex A (informative) Environmental aspects

Annex B (informative) Suggested maximum values of contaminants in feed water

Annex C (informative) Temperature and time tolerances during the small load thermometric test

Annex D (informative) Guidance for installation and operational qualification tests which can be included in the instructions for use supplied with a sterilizer

Annex E (informative) Criteria for identifying sterilizers as the same type

Annex F (normative) Protective measures

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

Bibliography