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BS EN 13060:2014+A1:2018 Small steam sterilizers, 2018
- undefined
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General technical requirements [Go to Page]
- 4.1 Dimensions
- 4.2 Materials
- 4.3 Design and construction [Go to Page]
- 4.3.1 General
- 4.3.2 Doors and locking devices
- 4.3.3 Test connection(s)
- 4.3.4 Air filter
- 4.3.5 Vibrations
- 4.3.6 Noise
- 4.4 Instrumentation, indication and registration devices [Go to Page]
- 4.4.1 General
- 4.4.2 Instruments and indicators [Go to Page]
- 4.4.2.1 General
- 4.4.2.2 Sterilizer chamber temperature indicating instrument
- 4.4.2.3 Sterilizer chamber pressure instrument
- 4.4.2.4 Jacket pressure indicating instrument
- 4.4.3 Indicating devices [Go to Page]
- 4.4.3.1 Loading side of the sterilizer
- 4.4.3.2 Double ended sterilizer
- 4.4.3.3 Acoustic signals
- 4.4.3.4 Cycle counter
- 4.4.3.5 Air leak indication
- 4.4.4 Recorders and recordings [Go to Page]
- 4.4.4.1 General
- 4.4.4.2 Recorders producing analogue records
- 4.4.4.3 Recorders producing digital records
- 4.4.5 Process evaluation system
- 4.5 Control systems [Go to Page]
- 4.5.1 Process control
- 4.5.2 Performance verification
- 4.5.3 Sterilization process fault indication systems
- 4.5.4 Software
- 4.6 Process [Go to Page]
- 4.6.1 General
- 4.6.2 Sterilization temperature, sterilization temperature band, holding time
- 4.6.3 Time-temperature relationships
- 4.6.4 Equilibration time
- 4.7 Services and local environment [Go to Page]
- 4.7.1 General
- 4.7.2 Electrical supply
- 4.7.3 Water supply for steam generation in the sterilizer
- 4.7.4 Drains
- 4.7.5 Compressed air for control systems
- 4.7.6 Water used other than for steam generation
- 4.7.7 External steam supply to the sterilizer
- 4.8 Information to be provided [Go to Page]
- 4.8.1 General
- 4.8.2 Pre-purchase information
- 4.8.3 Instructions for Use
- 4.8.4 Technical Information
- 4.9 Marking [Go to Page]
- 4.9.1 Marking of the pressure vessel
- 4.9.2 Marking of the sterilizer and the packaging
- 4.10 Accessories
- 5 Performance requirements [Go to Page]
- 5.1 General
- 5.2 Air leakage rate
- 5.3 Attainment of the sterilization conditions
- 5.4 Product compatibility [Go to Page]
- 5.4.1 Dynamic sterilizer chamber pressure test
- 5.4.2 Maximum allowable temperature
- 5.5 Drying
- 5.6 Microbicidal efficacy
- 5.7 Non-condensable gases
- 6 Safety, risk control and usability [Go to Page]
- 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 [Go to Page]
- 7.1 General
- 7.2 Type tests
- 7.3 Works test
- 7.4 Installation tests
- 8 Test equipment [Go to Page]
- 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 [Go to Page]
- 8.5.1 Absolute pressure indicator
- 8.5.2 Absolute pressure indicator for the determination of the ambient atmospheric pressure
- 8.5.3 Stopwatch
- 8.6 Porous load [Go to Page]
- 8.6.1 General
- 8.6.2 Small porous load, single wrapped [Go to Page]
- 8.6.2.1 General
- 8.6.2.2 Standard test pack according to EN 8675
- 8.6.3 Small porous load, double wrapped
- 8.6.4 Small porous items, single wrapped
- 8.6.5 Small porous items, double wrapped
- 8.6.6 Full porous load, single wrapped
- 8.6.7 Full porous load, double wrapped
- 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 [Go to Page]
- 10.1 General requirements on technical tests [Go to Page]
- 10.1.1 General
- 10.1.2 Apparatus
- 10.1.3 Type tests
- 10.1.4 Works and installation tests, as applicable
- 10.2 Air leakage test [Go to Page]
- 10.2.1 Apparatus
- 10.2.2 Type test and works/installation test procedure
- 10.3 Dynamic sterilizer chamber pressure test [Go to Page]
- 10.3.1 Apparatus
- 10.3.2 Type test procedure
- 10.4 Empty chamber test [Go to Page]
- 10.4.1 Apparatus
- 10.4.2 Type test procedure
- 10.4.3 Works/installation test procedure
- 10.5 Solid load test [Go to Page]
- 10.5.1 Apparatus
- 10.5.2 Type and works/installation test procedures
- 10.6 Narrow lumen test [Go to Page]
- 10.6.1 Apparatus
- 10.6.2 Type test and works/installation test procedure
- 10.7 Simple hollow item test [Go to Page]
- 10.7.1 Thermometric test (optional for works and installation tests) [Go to Page]
- 10.7.1.1 Apparatus
- 10.7.1.2 Type test procedure
- 10.7.1.3 Works/installation test procedure
- 10.7.2 Chemical indicator system test (works or installation tests only) [Go to Page]
- 10.7.2.1 Apparatus
- 10.7.2.2 Works/installation test procedure
- 10.8 Small porous load test [Go to Page]
- 10.8.1 Apparatus
- 10.8.2 Type test procedure
- 10.8.3 Works/installation test procedure
- 10.9 Full porous load test (single and double wrapped) [Go to Page]
- 10.9.1 Apparatus
- 10.9.2 Type test procedure
- 10.9.3 Works/installation test procedure
- 10.10 Small porous items test (single and double wrapped) [Go to Page]
- 10.10.1 Apparatus
- 10.10.2 Type test procedure
- 10.10.3 Works/installation test procedure
- 10.11 Solid load dryness test [Go to Page]
- 10.11.1 Apparatus
- 10.11.2 Type test procedure
- 10.11.3 Works/installation test procedure
- 10.12 Porous load dryness test (small and full, single and double wrapped) [Go to Page]
- 10.12.1 Apparatus
- 10.12.2 Type test procedure
- 10.12.3 Works/installation test procedure
- 10.13 Small porous items dryness test (single and double wrapped) [Go to Page]
- 10.13.1 Apparatus
- 10.13.2 Type test procedure
- 10.13.3 Works/installation test procedure
- 10.14 Non-condensable gases test [Go to Page]
- 10.14.1 Apparatus
- 10.14.2 Type test
- 10.15 Microbiological test for solid loads [Go to Page]
- 10.15.1 Apparatus
- 10.15.2 Type test and works/installation test procedure
- 10.16 Microbiological test for narrow lumens [Go to Page]
- 10.16.1 Apparatus
- 10.16.2 Type test and works/installation test procedure
- 10.17 Microbiological test for simple hollow item [Go to Page]
- 10.17.1 Apparatus
- 10.17.2 Type test and works/installation test procedure
- 10.18 Microbiological test for small porous loads [Go to Page]
- 10.18.1 Apparatus
- 10.18.2 Type test and works/installation test procedure
- 10.19 Microbiological test for full porous loads [Go to Page]
- 10.19.1 Apparatus
- 10.19.2 Type test and works/installation test procedure
- 10.20 Microbiological test for small porous items [Go to Page]
- 10.20.1 Apparatus
- 10.20.2 Type test and works/installation test procedure
- 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 [Go to Page]
- F.1 Air leakage test
- F.2 Dynamic sterilizer chamber pressure test
- F.3 Empty chamber test
- F.4 Small porous load test
- F.5 Full porous load test
- F.6 Solid load test
- F.7 Small porous items
- F.8 Narrow lumen test
- F.9 Simple hollow item test
- F.10 Solid load dryness test
- F.11 Porous load dryness test
- F.12 Non-condensable gases test
- F.13 Microbiological test for small porous loads
- F.14 Microbiological test for full porous loads
- F.15 Microbiological test for small porous items
- Annex G (informative)Example of a process challenge device for narrow lumen
- Annex ZA Annex ZA(informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices [Go to Page]
