PREN 285 : DRAFT 2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Mechanical components
5 Process components
6 Instrumentation, indicating and recording devices
7 Control systems
8 Performance requirements
9 Sound power and vibration
10 Rate of pressure change
11 Safety, risk control and usability
12 Packaging and marking
13 Service and local environment
14 Testing
15 Hollow load test
16 Thermometric te
17 Bowie and Dick test
18 Air leakage test
19 Air detector tests
20 Load dryness test
21 Steam quality test
22 Dynamic sterilizer chamber pressure test
23 Test apparatus, equipment and material
24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer
Annex A (informative) - Environmental aspects
Annex B (informative) - Steam supply: suggested maximum
        values of contaminants in feed water and condensate
Annex C (informative) - Temperature and time tolerances
        during the small load thermometric test
Annex D (informative) - Guidance for installation and
        operational qualification tests to 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) - Test procedures
Annex G (informative) - Assessing hazards caused by door
        movement
Annex H (normative) - Additional requirements according to
        machinery function
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on medical devices
Bibliography

Describes requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules.