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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
Hardcopy , PDF
English
31-01-2016
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
BS EN 285.
| Committee |
LBI/35
|
| DocumentType |
Draft
|
| Pages |
103
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN 285 : DRAFT 2013 | Identical |
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