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BS EN 13060:2025 Sterilizers for medical purposes. Small steam sterilizers. Requirements and testing >
BS EN 13060:2025 Sterilizers for medical purposes. Small steam sterilizers. Requirements and testing, 2025
- undefined
- European foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- Table 1 — Types of sterilization cycles
- 4 General [Go to Page]
- 5 Equipment design and construction [Go to Page]
- 6 Indicating, monitoring, controlling and recording [Go to Page]
- Table 2 — Data and limiting values to be recorded
- Figure 1 — Diagram of a specimen sterilization cycle (given as an example only) [Go to Page]
- Table 3 — Time-temperature relationships for sterilization conditions [Go to Page]
- 7 Services and local environment [Go to Page]
- 8 Emissions [Go to Page]
- 9 Test instrumentation
- 10 Performance and assessment [Go to Page]
- 11 Information supplied by the manufacturer [Go to Page]
- Table 4 — Minimum information to be provided
- Table 5 — Example of a table to be made available prior to purchase and with the instructions for use (informative) [Go to Page]
- Annex A (normative) Test programme
- A.1 Categories of tests
- A.1.1 General
- A.2 Type tests
- A.3 Works test
- A.4 Installation tests
- A.5 Test programme
- Table A.1 — Recommended test programme
- A.6 Rationale for the tests (informative)
- A.6.1 Air leakage test
- A.6.2 Dynamic sterilizer chamber pressure test
- A.6.3 Empty chamber test
- A.6.4 Small porous load test
- A.6.5 Full porous load test
- A.6.6 Solid load test
- A.6.7 Small porous items
- A.6.8 Narrow lumen test
- A.6.9 Simple hollow item test
- A.6.10 Solid load dryness test
- A.6.11 Porous load dryness test
- A.6.12 Microbiological test for small porous loads
- A.6.13 Microbiological test for full porous loads
- A.6.14 Microbiological test for small porous items
- A.6.15 Microbiological test for solid load
- A.6.16 Microbiological test for narrow lumens
- A.6.17 Microbiological test for simple hollow items
- Annex B (normative) Test equipment
- B.1 Test equipment
- B.2 Temperature sensors
- B.3 Thermometric recording instrument
- B.4 Pressure measurement and recording instrument
- B.5 Test equipment for the performance of the air leakage test
- B.5.1 Absolute pressure indicator
- B.5.2 Absolute pressure indicator for the determination of the ambient atmospheric pressure
- B.5.3 Stopwatch
- B.6 Process challenge device (PCD) and chemical indicator for narrow lumen
- B.7 Process challenge device and chemical indicator for simple hollow item
- B.8 Balance for load dryness test
- Annex C (normative) Test loads
- C.1 Test loads
- C.2 Porous load
- C.2.1 General
- C.2.2 Small porous load, single wrapped
- C.2.2.1 General
- C.2.2.2 Standard test pack in accordance with EN ISO 11140-6
- C.2.3 Small porous load, double wrapped
- C.2.4 Small porous items, single wrapped
- C.2.5 Small porous items, double wrapped
- C.2.6 Full porous load, single wrapped
- C.2.7 Full porous load, double wrapped
- C.3 Solid load, unwrapped
- C.4 Solid load, single wrapped
- C.5 Solid load, double wrapped
- Annex D (normative) Test procedures
- D.1 Test procedures
- D.1.1 General
- D.1.2 Apparatus
- D.1.3 Type tests
- D.1.4 Works and installation tests, as applicable
- D.2 Air leakage test
- D.2.1 Apparatus
- D.2.2 Type test and works/installation test procedure
- Figure D.1— Example of a pressure curve during the air leakage test
- D.3 Dynamic sterilizer chamber pressure test
- D.3.1 Apparatus
- D.3.2 Type test procedure
- D.4 Empty chamber test
- D.4.1 Apparatus
- D.4.2 Type test procedure
- D.4.3 Works/installation test procedure
- D.5 Solid load test
- D.5.1 Apparatus
- D.5.2 Type and works/installation test procedures
- D.6 Narrow lumen test
- D.6.1 Apparatus
- D.6.2 Type test and works/installation test procedure
- D.7 Simple hollow item test
- D.7.1 Thermometric test (optional for works and installation tests)
- D.7.1.1 Apparatus
- D.7.1.2 Type test procedure
- D.7.1.3 Works/installation test procedure
- D.7.2 Chemical indicator system test (works or installation tests only)
- D.7.2.1 Apparatus
- D.7.2.2 Works/installation test procedure
- D.8 Small porous load test
- D.8.1 Apparatus
- D.8.2 Type test procedure
- Figure D.2 — Location of temperature sensors in the small porous load type test
- D.8.3 Works/installation test procedure
- Figure D.3 — Location of temperature sensors in the small porous load works/installation test
- D.9 Full porous load test (single and double wrapped)
- D.9.1 Apparatus
- D.9.2 Type test procedure
- Figure D.4 — Location of temperature sensors in the full porous load type test
- D.9.3 Works/installation test procedure
- Figure D.5 — Location of temperature sensors in the full porous load works/installation test
- D.10 Small porous items test (single and double wrapped)
- D.10.1 Apparatus
- D.10.2 Type test procedure
- Figure D.6 — Location of temperature sensors in the test load 'small porous items' type test
- D.10.3 Works/installation test procedure
- Figure D.7 — Location of temperature sensors in the test load 'small porous items' works/installation test
- D.11 Solid load dryness test
- D.11.1 Apparatus
- D.11.2 Type test procedure
- D.11.3 Works/installation test procedure
- D.12 Porous load dryness test (small and full, single and double wrapped)
- D.12.1 Apparatus
- D.12.2 Type test procedure
- D.12.3 Works/installation test procedure
- D.13 Small porous items dryness test (single and double wrapped)
- D.13.1 Apparatus
- D.13.2 Type test procedure
- D.13.3 Works/installation test procedure
- D.14 Microbiological test for solid loads
- D.14.1 Apparatus
- D.14.2 Type test and works/installation test procedure
- D.15 Microbiological test for narrow lumens
- D.15.1 Apparatus
- D.15.2 Type test and works/installation test procedure
- D.16 Microbiological test for simple hollow item
- D.16.1 Apparatus
- D.16.2 Type test and works/installation test procedure
- D.17 Microbiological test for small porous loads
- D.17.1 Apparatus
- D.17.2 Type test and works/installation test procedure
- D.18 Microbiological test for full porous loads
- D.18.1 Apparatus
- D.18.2 Type test and works/installation test procedure
- D.19 Microbiological test for small porous items
- D.19.1 Apparatus
- D.19.2 Type test and works/installation test procedure
- Annex E (informative) Monitoring system
- E.1 General
- E.2 Principle
- E.3 Equipment
- Figure E.1 — Illustration 1 of the interrelationship between control and recording for small steam sterilizers of the first design type using one temperature sensor, as specified by EN 13060:2014+A1:2018, 4.4.5.1
- Figure E.2 — Illustration 2 of the interrelationship between control and recording for small steam sterilizers of the second design type using two temperature sensors
- Annex F (informative) Suggested maximum limits of contaminants in and specifications for water for steam sterilization
- F.1 Suggested maximum limits of contaminants in and specifications for water for steam sterilization
- Table F.1 — Contaminants of condensate and feed water
- Annex G (informative) Load support systems
- Annex H (informative) Illustrations of the interrelationship between control and recording
- H.1 Overview
- H.2 Illustration 1
- Figure H.1 — Illustration 1 of the interrelationship between control and recording [SOURCE: ISO/TS 22421:2021, Figure B.1]
- H.3 Illustration 2
- Figure H.2 — Illustration 2 of the interrelationship between control and recording [ SOURCE: ISO/TS 22421:2021, Figure B.2]
- H.4 Illustration 3
- Figure H.3 — Illustration 3 of the interrelationship between control and recording [SOURCE: ISO/TS 22421:2021, Figure B.3]
- Annex I (informative) Environmental aspects
- I.1 Environmental impact
- I.2 Steam
- I.3 Product life cycle
- Annex ZA (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
- Table ZA.1 — Correspondence between this European Standard and Annex I of Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance syst...
- 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 1, item12 of Regulation (EU) 2017/745)
- Table ZA.3 — Prevailing terms of Regulation (EU) 2017/754 for the use of this European standard under that Regulation
- Bibliography [Go to Page]