ДСТУ EN 13060:2019 Стерилизаторы паровые малогабаритные (EN 13060:2014, IDT)

ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ

Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
(ДП «УкрНДНЦ»)

Наказ від 20.06.2019 № 163

EN 13060:2014

Small steam sterilizers

прийнято як національний стандарт
методом підтвердження за позначенням

ДСТУ EN 13060:2019
(EN 13060:2014, IDT)

Стерилізатори парові малогабаритні

З наданням чинності від 2019–08–01

 

 
 
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 General technical requirements

4.1 Dimensions

4.2 Materials

4.3 Design and construction

4.4 Instrumentation, indication and registration devices

4.5 Control systems

4.6 Process

4.7 Services and local environment

4.8 Information to be provided

4.9 Marking

4.10 Accessories

5 Performance requirements

5.1 General

5.2 Air leakage rate

5.3 Attainment of the sterilization conditions

5.4 Product compatibility

5.5 Drying

5.6 Microbicidal efficacy

5.7 Non-condensable gases

6 Safety, risk control and usability

6.1 General requirements

6.2 Requirements for EMC

6.3 Requirements for pressure equipment

6.4 Requirements for risk control

7 Categories of tests

7.1 General

7.2 Type tests

7.3 Works test

7.4 Installation tests

8 Test equipment

8.1 General

8.2 Temperature sensors

8.3 Thermometric recording instrument

8.4 Pressure measurement and recording instrument

8.5 Test equipment for the performance of the air leakage test

8.6 Porous load

8.7 Solid load, unwrapped

8.8 Solid load, single wrapped

8.9 Solid load, double wrapped

8.10 Process challenge device (PCD) and chemical indicator for narrow lumen

8.11 Process challenge device and chemical indicator for simple hollow item

8.12 Balance for load dryness test

9 Test programme

10 Test methods

10.1 General requirements on technical tests

10.2 Air leakage test

10.3 Dynamic sterilizer chamber pressure test

10.4 Empty chamber test

10.5 Solid load test

10.6 Narrow lumen test

10.7 Simple hollow item test

10.8 Small porous load test

10.9 Full porous load test (single and double wrapped)

10.10 Small porous items test (single and double wrapped)

10.11 Solid load dryness test

10.12 Porous load dryness test (small and full, single and double wrapped)

10.13 Small porous items dryness test (single and double wrapped)

10.14 Non-condensable gases test

10.15 Microbiological test for solid loads

10.16 Microbiological test for narrow lumens

10.17 Microbiological test for simple hollow item

10.18 Microbiological test for small porous loads

10.19 Microbiological test for full porous loads

10.20 Microbiological test for small porous items

Annex A (informative) Clarification of the definition of narrow lumens and simple hollow items (see 3.18 and 3.30)

Annex B (informative) Process evaluation system

Annex C (informative) Suggested maximum limits of contaminants in and specification for water for steam sterilization

Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use

Annex E (informative) Load support systems

Annex F (informative) Rationale for the tests

Annex G (informative) Example of a process challenge device for narrow lumen

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

Bibliography