BS EN 1422:2014
$198.66
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 54 |
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: – the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; – the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products. NOTE 3 For further information see ISO 10993 7.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Foreword |
| 7 | Introduction |
| 8 | 1 Scope 2 Normative references |
| 9 | 3 Terms and definitions |
| 14 | 4 Technical requirements 4.1 General 4.1.1 Risk control and usability |
| 15 | 4.1.2 Materials 4.2 Sterilizer chamber 4.2.1 Chamber size 4.2.2 Doors, closures and interlocks of the sterilizer chamber |
| 16 | 4.2.3 Test connections |
| 17 | 4.3 Design and construction 4.3.1 General 4.3.2 EO vaporizers 4.3.3 Pipework and fittings 4.3.4 Evacuation system |
| 18 | 4.3.5 Control valves 4.3.6 Thermal insulation 4.3.7 Electrical and mechanical safety 4.3.8 Air or inert gas filter 4.3.9 Emission control |
| 19 | 4.3.10 Framework and panelling 4.3.11 Loading equipment 4.3.12 Transport 4.4 Indicating, measuring, and recording instruments 4.4.1 General |
| 20 | 4.4.2 Temperature sensor 4.4.3 Temperature indicating instruments |
| 21 | 4.4.4 Pressure sensors 4.4.5 Timers and time indicating instruments 4.4.6 Sterilizing cycle counter 4.4.7 Relative humidity (RH) sensors 4.4.8 Ethylene Oxide (EO) concentration-measurement |
| 22 | 4.4.9 Recording instruments 4.4.9.1 General 4.4.9.2 Recording instrumentation (analogue format) |
| 23 | 4.4.9.3 Recording instrumentation producing alphanumerical print-outs (digital format) 4.4.10 Indicating instruments |
| 24 | 5 Process control 5.1 General |
| 25 | 5.2 Software verification and validation 5.3 Sterilization cycle and automatic control 5.3.1 Automatic control |
| 26 | 5.3.2 Sterilization cycle 5.3.2.1 Automatic controller 5.3.2.2 Chamber pre-heating/cooling 5.3.2.3 Stage 1: Air removal 5.3.2.4 Stage 2: Automatic Leak Rate Test |
| 27 | 5.3.2.5 Stage 3: conditioning (if used) 5.3.2.6 Stage 4: EO injection 5.3.2.7 Stage 5: EO exposure 5.3.2.8 Stage 6: EO removal 5.3.2.9 Stage 7: Flushing |
| 28 | 5.3.2.10 Stage 8: Air admission 5.3.2.11 Stage 9: Cycle complete 5.3.2.12 Maintenance leak rate test cycle 5.3.2.12.1 Sterilization cycles operating at sub-atmospheric pressure 5.3.2.12.2 Sterilization cycles operating at super-atmospheric pressure |
| 29 | 5.4 Override of automatic control 5.5 Fault |
| 30 | 6 Performance requirements 6.1 Sterilizing performance 6.1.1 Loading configuration 6.1.2 Physical parameters 6.1.2.1 Heating of the sterilizer chamber internal surfaces 6.1.2.2 Temperature profile for an empty sterilizer chamber 6.1.2.3 Pressure profile 6.1.2.4 Sterilant 6.1.3 Microbiological efficacy |
| 31 | 6.2 EO removal (flushing) 6.3 Aeration 7 Sound power 8 Packaging, marking and labelling |
| 32 | 9 Information to be supplied by the manufacturer |
| 34 | 10 Service and local environment 10.1 General |
| 35 | 10.2 Electricity 10.3 Sterilant 10.4 Circulation systems 10.5 Steam |
| 36 | 10.6 Water 10.7 Air and inert gasses 10.8 Drainage and discharges 10.9 Ventilation and environment 10.10 Lighting |
| 37 | Annex A (normative) Test instrumentation |
| 38 | Annex B (normative) Leak test cycle |
| 39 | Annex C (normative) Sterilizer chamber profile testing C.1 Sterilizer chamber internal surfaces C.2 Empty sterilizer chamber |
| 40 | Annex D (normative) Microbiological test for EO sterilizers D.1 General D.2 Test equipment |
| 41 | D.3 Procedure |
| 42 | D.4 Interpretation of results |
| 43 | Annex E (informative) Environmental aspects E.1 Environmental aspects regarding the life cycle of EO sterilizers E.2 EO (brief description) E.3 Environmental impact |
| 44 | Table E.1 — Environmental aspects addressing clauses of this standard |
| 46 | 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 |
| 48 | 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) |
| 50 | Bibliography |
