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BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers, 2016
- European foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Mechanical components [Go to Page]
- 4.1 Dimensions
- 4.2 Materials
- 4.3 Pressure vessel [Go to Page]
- 4.3.1 General
- 4.3.2 Double ended sterilizers
- 4.3.3 Test connections
- Figure 1 — Connection for test
- Figure 2 — Connection sleeve for thermo elements [Go to Page]
- 4.3.4 Insulation
- 4.4 Framework and panelling
- Table 1 —Tolerances for the aperture into which the sterilizer is installed
- Table 2 — Deviation from vertical and horizontal flatness and alignment [Go to Page]
- 4.5 Loading equipment
- 4.6 Transport
- 5 Piping system and components [Go to Page]
- 5.1 Pipework and fittings
- 5.2 Steam source [Go to Page]
- 5.2.1 Steam supply from a dedicated steam generator
- 5.2.2 Steam supply from a central source
- 5.3 Air filter
- 5.4 Vacuum system
- 6 Measuring system, indicating and recording devices for temperature, pressure, time and status indicators [Go to Page]
- 6.1 General
- 6.2 Measuring system
- Figure 3 — Illustration of the measuring systems [Go to Page]
- 6.3 Status indicators
- 6.4 Measuring chains and time equipment [Go to Page]
- 6.4.1 Temperature probes
- 6.4.2 Temperature measuring chains for control, recording and indication
- 6.4.3 Pressure transducers
- 6.4.4 Pressure measuring chains for control, recording and indication
- 6.4.5 Time control and indicating equipment
- 6.5 Recording systems [Go to Page]
- 6.5.1 General
- 6.5.2 Records
- Figure 4 — Diagram of specimen operation cycle given as an example only
- Table 3 — Examples of data to be recorded [Go to Page]
- 6.5.3 Data processing [Go to Page]
- 6.5.3.1 General
- 6.5.3.2 Resolution of graphic records of pressure and temperature
- 6.5.3.3 Resolution of tabular records of pressure and temperature
- 7 Control systems [Go to Page]
- 7.1 General
- 7.2 Fault indication system
- 7.3 Software verification and validation
- 8 Performance requirements [Go to Page]
- 8.1 Steam penetration
- 8.2 Physical parameters [Go to Page]
- 8.2.1 Temperature characteristics [Go to Page]
- 8.2.1.1 Sterilization temperature band
- 8.2.1.2 Small load, thermometric
- 8.2.1.3 Full load, thermometric
- 8.2.2 Bowie and Dick test
- 8.2.3 Air leakage
- 8.2.4 Air detector [Go to Page]
- 8.2.4.1 General
- 8.2.4.2 Air detector, small load
- 8.2.4.3 Air detector, full load
- 8.2.4.4 Air detector function
- 8.2.5 Hollow load test
- 8.3 Load dryness [Go to Page]
- 8.3.1 Load dryness, small load, textiles
- 8.3.2 Load dryness, full load, textiles
- 8.3.3 Load dryness, metal load
- 9 Sound power and vibration [Go to Page]
- 9.1 Sound power
- 9.2 Vibration
- 10 Rate of pressure change
- 11 Safety, risk control and usability [Go to Page]
- 11.1 Protective measures
- 11.2 Risk control, usability
- 12 Packaging and marking
- 13 Service and working environment [Go to Page]
- 13.1 General
- 13.2 Electrical supply
- 13.3 Steam supply to the sterilizer chamber [Go to Page]
- 13.3.1 Non-condensable gases
- 13.3.2 Dryness value
- 13.3.3 Superheat
- 13.3.4 Contaminants
- Table 4 — Suggested maximum values of contaminants in condensate from steam supply to the sterilizer chamber [Go to Page]
- 13.3.5 Pressure fluctuation
- 13.3.6 Feed water
- 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 [Go to Page]
- 14.1 General
- Table 5 — Recommended test programme [Go to Page]
- 14.2 Calibration
- 14.3 Environment
- 15 Hollow load test [Go to Page]
- 15.1 General
- 15.2 Apparatus
- 15.3 Procedure
- 16 Thermometric tests [Go to Page]
- 16.1 Small load, thermometric [Go to Page]
- 16.1.1 General
- 16.1.2 Apparatus
- Figure 5 — Example of a method used to introduce temperature probes into a sterilizer chamber [Go to Page]
- 16.1.3 Procedure
- Figure 6 — Location of temperature probes [Go to Page]
- 16.2 Full load, thermometric [Go to Page]
- 16.2.1 General
- 16.2.2 Apparatus
- 16.2.3 Procedure
- 17 Bowie and Dick test [Go to Page]
- 17.1 General
- 17.2 Apparatus
- 17.3 Procedure
- 18 Air leakage test [Go to Page]
- 18.1 General
- 18.2 Apparatus
- 18.3 Procedure
- 18.3.2 Stabilize the temperature of the sterilizer chamber by carrying out one of the following:
- 19 Air detector tests [Go to Page]
- 19.1 General
- 19.2 Air detector, small load [Go to Page]
- 19.2.1 Apparatus
- 19.2.1.7 Connected services complying with Clause 13. [Go to Page]
- 19.2.2 Procedure
- 19.3 Air detector, full load [Go to Page]
- 19.3.1 Apparatus
- 19.3.1.2 Thermometric recording instrument as described in 23.3.4.1. [Go to Page]
- 19.3.2 Procedure
- 19.3.2.13 If the air leakage causes the sterilizer chamber pressure to rise more than 1,1 kPa/min re-adjust the metering device to cause a pressure rise of (1,0 ± 0,1) kPa/min.
- 19.4 Air detector function [Go to Page]
- 19.4.1 General
- 19.4.2 Apparatus
- 19.4.3 Procedure
- 20 Load dryness test [Go to Page]
- 20.1 Load dryness, small load, textiles [Go to Page]
- 20.1.1 General
- 20.1.2 Apparatus
- 20.1.3 Procedure
- 20.2 Load dryness, full load, textile [Go to Page]
- 20.2.1 General
- 20.2.2 Apparatus
- 20.2.3 Procedure
- 20.3 Load dryness, metal [Go to Page]
- 20.3.1 General
- 20.3.2 Apparatus
- 20.3.3 Procedure
- 21 Steam quality test [Go to Page]
- 21.1 Non-condensable gases [Go to Page]
- 21.1.1 General
- 21.1.2 Apparatus
- 21.1.3 Procedure
- Figure 7 — Diagrammatic representation of the apparatus for the measurement of non-condensable gases [Go to Page]
- 21.2 Dryness [Go to Page]
- 21.2.1 General
- 21.2.2 Apparatus
- Figure 8 — Pitot tube [Go to Page]
- 21.2.3 Procedure
- Figure 9 — Diagrammatic representation of the apparatus for the measurement of steam dryness value [Go to Page]
- 21.3 Superheat [Go to Page]
- 21.3.1 General
- 21.3.2 Apparatus
- Figure 10 — Expansion tube [Go to Page]
- 21.3.3 Procedure
- Figure 11 — Diagrammatic representation of the apparatus for the measurement of superheat [Go to Page]
- 21.4 Sampling of steam condensate [Go to Page]
- 21.4.1 General
- 21.4.2 Apparatus
- 21.4.3 Procedure
- Figure 12 — Apparatus for sampling steam condensate
- 22 Rate of pressure change [Go to Page]
- 22.1 General
- 22.2 Apparatus
- 22.3 Procedure
- 23 Test apparatus, equipment and material [Go to Page]
- 23.1 Standard test pack
- Figure 13 — Folding and assembling the test pack [Go to Page]
- 23.2 Reduced test pack
- 23.3 Test instruments [Go to Page]
- 23.3.1 General
- 23.3.2 Pressure instruments
- 23.3.3 Temperature instruments [Go to Page]
- 23.3.3.1 Probes for testing
- 23.3.3.2 Temperature measuring chains
- 23.3.4 Recording instruments [Go to Page]
- 23.3.4.1 Thermometric recording instrument
- 23.3.4.2 Pressure recording instrument
- 23.4 Full load, textiles
- 23.5 Test pack, metal
- Figure 14 — Details of test box for test load dryness, metal [Go to Page]
- 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
- Table A.1 — Environmental aspects addressing clauses of this European Standard
- Annex B (informative) Suggested maximum values of contaminants in feed water
- Table B.1 — Contaminants in feed water supplied to a dedicated steam generator
- Annex C (informative) Temperature and time tolerances during the small load thermometric test
- Figure C.1 — 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
- Table D.1 — Suggested tests
- 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
- Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices
- Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to Article 3 of amended Directive 93/42/EEC)
- Bibliography [Go to Page]
