ДСТУ EN 13060:2019 Стерилізатори парові малогабаритні (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
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