BS EN 13060:2014+A1:2018
$215.11
Small steam sterilizers
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 88 |
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665‑1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions |
| 18 | 4 General technical requirements 4.1 Dimensions 4.2 Materials |
| 19 | 4.3 Design and construction 4.3.1 General 4.3.2 Doors and locking devices |
| 20 | 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 4.4.1 General |
| 21 | 4.4.2 Instruments and indicators 4.4.2.1 General 4.4.2.2 Sterilizer chamber temperature indicating instrument 4.4.2.3 Sterilizer chamber pressure instrument |
| 22 | 4.4.2.4 Jacket pressure indicating instrument 4.4.3 Indicating devices 4.4.3.1 Loading side of the sterilizer |
| 23 | 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 4.4.4.1 General |
| 24 | 4.4.4.2 Recorders producing analogue records |
| 25 | 4.4.4.3 Recorders producing digital records |
| 28 | 4.4.5 Process evaluation system |
| 29 | 4.5 Control systems 4.5.1 Process control |
| 30 | 4.5.2 Performance verification 4.5.3 Sterilization process fault indication systems 4.5.4 Software |
| 31 | 4.6 Process 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 |
| 32 | 4.7 Services and local environment 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 |
| 33 | 4.7.7 External steam supply to the sterilizer 4.8 Information to be provided 4.8.1 General 4.8.2 Pre-purchase information 4.8.3 Instructions for Use 4.8.4 Technical Information |
| 37 | 4.9 Marking 4.9.1 Marking of the pressure vessel 4.9.2 Marking of the sterilizer and the packaging |
| 38 | 4.10 Accessories 5 Performance requirements 5.1 General |
| 39 | 5.2 Air leakage rate 5.3 Attainment of the sterilization conditions 5.4 Product compatibility 5.4.1 Dynamic sterilizer chamber pressure test 5.4.2 Maximum allowable temperature |
| 40 | 5.5 Drying 5.6 Microbicidal efficacy 5.7 Non-condensable gases 6 Safety, risk control and usability 6.1 General requirements |
| 41 | 6.2 Requirements for EMC 6.3 Requirements for pressure equipment |
| 42 | 6.4 Requirements for risk control 7 Categories of tests 7.1 General |
| 43 | 7.2 Type tests 7.3 Works test |
| 44 | 7.4 Installation tests 8 Test equipment 8.1 General 8.2 Temperature sensors |
| 45 | 8.3 Thermometric recording instrument 8.4 Pressure measurement and recording instrument |
| 46 | 8.5 Test equipment for the performance of the air leakage test 8.5.1 Absolute pressure indicator |
| 47 | 8.5.2 Absolute pressure indicator for the determination of the ambient atmospheric pressure 8.5.3 Stopwatch 8.6 Porous load 8.6.1 General |
| 48 | 8.6.2 Small porous load, single wrapped 8.6.2.1 General 8.6.2.2 Standard test pack according to EN 8675 8.6.3 Small porous load, double wrapped |
| 49 | 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 |
| 50 | 8.10 Process challenge device (PCD) and chemical indicator for narrow lumen 8.11 Process challenge device and chemical indicator for simple hollow item |
| 51 | 8.12 Balance for load dryness test 9 Test programme |
| 53 | 10 Test methods 10.1 General requirements on technical tests 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 10.2.1 Apparatus |
| 54 | 10.2.2 Type test and works/installation test procedure |
| 55 | 10.3 Dynamic sterilizer chamber pressure test 10.3.1 Apparatus 10.3.2 Type test procedure |
| 56 | 10.4 Empty chamber test 10.4.1 Apparatus 10.4.2 Type test procedure 10.4.3 Works/installation test procedure 10.5 Solid load test 10.5.1 Apparatus 10.5.2 Type and works/installation test procedures 10.6 Narrow lumen test 10.6.1 Apparatus |
| 57 | 10.6.2 Type test and works/installation test procedure 10.7 Simple hollow item test 10.7.1 Thermometric test (optional for works and installation tests) 10.7.1.1 Apparatus 10.7.1.2 Type test procedure 10.7.1.3 Works/installation test procedure |
| 58 | 10.7.2 Chemical indicator system test (works or installation tests only) 10.7.2.1 Apparatus 10.7.2.2 Works/installation test procedure 10.8 Small porous load test 10.8.1 Apparatus 10.8.2 Type test procedure 10.8.3 Works/installation test procedure |
| 59 | 10.9 Full porous load test (single and double wrapped) 10.9.1 Apparatus 10.9.2 Type test procedure 10.9.3 Works/installation test procedure |
| 60 | 10.10 Small porous items test (single and double wrapped) 10.10.1 Apparatus 10.10.2 Type test procedure 10.10.3 Works/installation test procedure 10.11 Solid load dryness test 10.11.1 Apparatus |
| 61 | 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) 10.12.1 Apparatus 10.12.2 Type test procedure |
| 62 | 10.12.3 Works/installation test procedure 10.13 Small porous items dryness test (single and double wrapped) 10.13.1 Apparatus 10.13.2 Type test procedure 10.13.3 Works/installation test procedure 10.14 Non-condensable gases test 10.14.1 Apparatus |
| 63 | 10.14.2 Type test |
| 66 | 10.15 Microbiological test for solid loads 10.15.1 Apparatus 10.15.2 Type test and works/installation test procedure 10.16 Microbiological test for narrow lumens 10.16.1 Apparatus 10.16.2 Type test and works/installation test procedure 10.17 Microbiological test for simple hollow item 10.17.1 Apparatus |
| 67 | 10.17.2 Type test and works/installation test procedure 10.18 Microbiological test for small porous loads 10.18.1 Apparatus 10.18.2 Type test and works/installation test procedure 10.19 Microbiological test for full porous loads 10.19.1 Apparatus 10.19.2 Type test and works/installation test procedure |
| 68 | 10.20 Microbiological test for small porous items 10.20.1 Apparatus 10.20.2 Type test and works/installation test procedure |
| 69 | Annex A (informative)Clarification of the definition of narrow lumens and simple hollow items (see 3.18 and 3.30) |
| 71 | Annex B (informative)Process evaluation system |
| 72 | Annex C (informative)Suggested maximum limits of contaminants in and specification for water for steam sterilization |
| 73 | Annex D (informative)Example of a table to be supplied with pre-purchase documentation and with the instructions for use |
| 74 | Annex E (informative)Load support systems |
| 75 | Annex F (informative)Rationale for the tests 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 |
| 76 | 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 |
| 77 | F.15 Microbiological test for small porous items |
| 78 | Annex G (informative)Example of a process challenge device for narrow lumen |
| 79 | Annex ZA Annex ZA(informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices |
