BS EN 14180:2014
$198.66
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 66 |
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: – for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; – for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Contents Page |
| 5 | Foreword |
| 6 | Introduction |
| 7 | 1 Scope 2 Normative references |
| 8 | 3 Terms and definitions |
| 13 | 4 Technical requirements 4.1 Sterilizer chamber 4.1.1 Materials |
| 14 | 4.1.2 Chamber size 4.1.3 Doors and interlocks of the sterilizer chamber |
| 15 | 4.1.4 Heating and insulating the sterilizer chamber 4.1.5 Test connections Figure 1 — Example of the connection for test instruments |
| 16 | Figure 2 — Example of thermometry entry connection 4.2 Design and construction 4.2.1 Risk control and usability 4.2.2 Safety |
| 17 | 4.2.3 Pressure equipment 4.2.4 Pipework and fittings 4.2.5 Evacuation system 4.2.6 Aeration system |
| 18 | 4.2.7 Framework and panelling 4.2.8 Accessories 4.2.9 Transport 4.3 Indicating, measuring, operating and recording devices 4.3.1 General |
| 19 | 4.3.2 Temperature measuring devices 4.3.3 Temperature indicating devices |
| 20 | Figure 3 — Arrangements for temperature and pressure sensors 4.3.4 Pressure measuring and indicating devices |
| 21 | 4.3.5 Timers and time indicating devices 4.3.6 Sterilizing cycle counter 4.3.7 Recording instruments 4.3.7.1 General requirements |
| 22 | 4.3.7.2 Recorders producing analogue records |
| 23 | 4.3.7.3 Recorders producing digital records 4.3.8 Indications and registrations |
| 24 | 5 Process control 5.1 General 5.2 Software verification and validation |
| 25 | 5.3 Operating cycle and automatic control |
| 26 | Figure 4 — Example of a LTSF sterilization process demonstrating relations of process parts 5.4 Override of automatic control 5.5 Fault |
| 27 | 6 Performance requirements 6.1 Sterilizing performance 6.1.1 Physical testing 6.1.1.1 Pre-heating 6.1.1.2 Sterilization temperature band 6.1.1.3 Temperature profile |
| 28 | 6.1.1.4 Temperature profile requirements 6.1.1.5 Pressure profile 6.1.1.6 Pressure profile requirements 6.1.1.7 Sterilant |
| 29 | 6.1.2 Lethality (Microbiological efficacy) 6.2 Desorption efficacy 6.3 Drying 7 Sound power and vibration |
| 30 | 8 Packaging, marking and labelling |
| 31 | 9 Information to be supplied by the manufacturer |
| 33 | 10 Service and local environment 10.1 General 10.2 Electricity 10.3 Sterilant |
| 34 | 10.4 Steam 10.5 Water 10.5.1 Water used for sterilizer operation 10.5.2 Feed water 10.6 Compressed air 10.7 Drainage and discharges |
| 35 | 10.8 Ventilation and environment 10.9 Lighting |
| 36 | Annex A (normative) Test methods A.1 General A.2 Test loads A.2.1 Small load A.2.1.1 General A.2.1.2 Small load unit A.2.2 Full load A.2.2.1 General |
| 37 | A.2.2.2 Full load unit A.3 Test procedures A.3.1 Test equipment A.3.2 Thermometric tests A.3.2.1 Sterilizer chamber pre-heating test |
| 38 | A.3.2.2 Small load temperature profile test A.3.2.3 Full load temperature profile test |
| 39 | A.3.3 Microbiological test A.3.4 Pressure profile tests A.3.4.1 Small load pressure profile test |
| 40 | A.3.4.2 Full load pressure profile test A.3.5 Desorption test |
| 41 | A.3.6 Drying test |
| 42 | Annex B (normative) Sterilizer classification and testing B.1 General B.2 Type of sterilizer |
| 43 | B.3 Testing B.3.1 General B.3.2 Type test B.3.3 Production test B.3.4 Installation qualification (IQ) |
| 44 | B.3.5 Operational qualification (OQ) Table B.1 — Summary of test programme |
| 45 | Annex C (normative) Test equipment C.1 Pressure instrumentation C.2 Temperature sensors C.3 Temperature recording instrument |
| 46 | C.4 Pressure recording instrument C.5 Desorption indicator |
| 47 | Table C.1 — Specification for filter paper used for desorption indicators C.6 Process challenge device (PCD) C.7 Biological indicators and systems C.8 Wrappings |
| 48 | Annex D (normative) Determination of formaldehyde residuals in a filter indicator D.1 Procedure for sample preparation D.2 Analysis of formaldehyde contents in filter indicator D.2.1 Equipment D.2.2 Extraction and evaluation procedure for processed indicators D.2.3 Extraction and evaluation procedure for the reference (blank) indicator |
| 49 | D.2.4 Calibration D.2.4.1 Principle D.2.4.2 Procedure |
| 50 | Figure D.1 — Example of a graph for residue evaluation |
| 51 | Annex E (informative) Formaldehyde residues on medical devices E.1 Assumptions for calculating limits for formaldehyde residues on medical devices Table E.1 — References E.2 Determination of formaldehyde residuals in sterilized goods E.2.1 General |
| 52 | Table E.2 — Approximate residual figures compared to filter paper [11] E.2.2 Test methods |
| 53 | Annex F (informative) Environmental aspects F.1 Environmental aspects regarding the life cycle of LTSF sterilizers F.2 Formaldehyde (brief description) F.3 Environmental impact |
| 54 | Table F.1 — Environmental aspects addressing clauses of this standard |
| 56 | 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 |
| 59 | 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) |
| 62 | Bibliography |
