20 460 234 age 1 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 Content 1 Scope... 3 2 Definitions and Acronyms... 3 3 How to obtain compliance to the Standard... 3 3.1 Type testing... 3 3.1.1 Retention at front aperture... 3 3.1.2 Leaktightness of carcass... 3 3.1.3 Filters... 4 3.1.4 roduct protection... 4 3.1.5 Cross contamination... 4 3.2 Installation testing... 4 3.2.1 Volumetric airflow rate measurements... 4 3.2.2 Check airflow patterns... 4 3.3 Guidance on manufacture... 4 3.3.1 Front aperture height... 4 3.3.2 Lightning... 4 3.3.3 Sound... 5 3.3.4 Vibration... 5 3.3.5 Stability... 5 3.3.6 Materials, general... 5 3.3.7 Glass and front window... 5 3.3.8 Electrical safety... 5 3.3.9 Gas supply safety... 6 3.3.10 Ergonomics... 6 3.3.11 Temparature... 6 4 Tests done... 6 5 erson... 6 6 Instrument / Series number / calibrated... 6 7 Conclusion... 7 8 Annex A... 8 9 Annex B... 9 9.1 Normal conditions... 9 9.2 If MSC is turned off after use... 9 10 Annex C... 10 11 Annex D... 12 age 2 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 1 Scope The scope of this document is to describe the compliance of the K-Systems L234 workstation to the standard EN 12469:2000. In general three types of performance testing can be distinguished: Type testing, Installation testing and routine maintenance testing. (See table 5 in EN 12469) Routine maintenance testing is a sub part of the installation testing as described in the standard. We have therefore chosen to verify that L234 comply type testing and relevant installation testing, as stated in table 5 in the standard. 2 Definitions and Acronyms 15 060 04 Definitions Testing is passed (). Not applicable (n/a). Testing is failed (F) 3 How to obtain compliance to the Standard The following paragraphs refers back to the test specifications listed in table 5 of the standard. See table 5 in annex D. 3.1 Type testing 3.1.1 Retention at front aperture KI method chosen and done testing. (See annex A) 3.1.2 Leaktightness of carcass Soap solution test method chosen and done testing. (See annex B) age 3 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 3.1.3 Filters Aerosol challenge method chosen and done testing. (See annex C) 3.1.4 roduct protection Microbiological method or alternative KI method. n/a 3.1.5 Cross contamination Microbiological method or alternative KI method. n/a 3.2 Installation testing 3.2.1 Volumetric airflow rate measurements Measurements must be made in the horizontal plane 50 mm to 100 mm above the top edge of the front aperture. Requirements in the standard states that the mean downflow velocity to achieve product protection must be within 0,25 m/s to 0,50 m/s. No individual measurements should differ from the mean by more than 20%. We measure mean 0,35 m/s. with a difference at min 9% and max 13% (See annex C). 3.2.2 Check airflow patterns Same as 3.2.1. (See annex C) 3.3 Guidance on manufacture 3.3.1 Front aperture height The height of the front aperture should be between 160 mm and 250 mm. We have 163,5 mm. 3.3.2 Lightning Lightning at the work surface should be at least 750 lux. age 4 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 We measure around 900 lux at the working positions. 3.3.3 Sound The sound level should not exceed 65 db A-weighted. We have measured 57 db A-weighted. 3.3.4 Vibration We have less than 0,005 mm RMS. At work surface between 20 Hz and 20000 Hz. 3.3.5 Stability Equipment is tilted in each direction to an angle of 10 from its normal position. Equipment has a force applied at its top, or at a height of 2 m if the equipment has a height more than 2 m. The force is 250 N, or 20 % of the weight of the equipment, whichever is less, and is applied in all directions except upwards. Conforming EN 61010-1 for stability. 3.3.6 Materials, general The material where micrio-organisms have contact whould be corrosion resistant, non-flammable and non-adsorbing. The tabletop where micro-organisms should be at is made of stainless steel, which is corrosion resistant, non-flammable and non-adsorbing. 3.3.7 Glass and front window Glass side windows complying to EN 61010-1. Transparent front window, can be taken off while system is not running, but must be mounted while in use. When working with IVF only a small opening is needed. 3.3.8 Electrical safety The MSC has been designed to, and are being tested at UL in Denmark, to conform EN 61010-1. In test age 5 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 3.3.9 Gas supply safety No flammable gas installed n/a 3.3.10 Ergonomics The design should ensure that maintenance can safety be carried out on the cabinet after installation. - Easy to remove back panel for filter replacement - Easy to open tray for cleaning - owder coated cabinet for easy cleaning - Stainless steel tabletop accept all normally use detergents and alcohol for cleaning 3.3.11 Temparature With no heat in tabletop temperature will not rise by more than 8 C. 4 Tests done - Downflow measurements - Inflow measurements - DO (HEA filter leakage) - KI-Discus 5 erson Mechanical Engineer Thomas Grau-Andersen 6 Instrument / Series number / calibrated - Testo 425 / 02052833 / 01-08-2012 - TDA-2G / 15747 / 03-09-2012 - Ki-Discus MK2 / K03/05-0188 / 22-08-2012 age 6 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 7 Conclusion Relevant tests from EN 12469:2000 is listed and show how L234 workstation comply to the class II standard. L234 workstation have successful ergonomics and the design ensure that maintenance can safety be carried out on the cabinet after installation. erformance results in brief: All airflow measurements such as downflow and inflow are complying to EN 12469:2000. DO test (HEA filter test) are complying to EN 12469:2000. The sound level are complying to EN 12469:2000. The vibration level are complying to EN 12469:2000. General design are complying to EN 12469:2000. age 7 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 8 Annex A The KI Discus test was performed: By: Thomas Grau-Andersen Date: 27-08-2012 On L234 S/N: roto 2 Instrumentation / calibration: Ki-Discus MK2 / 22-08-2012 The photo above shows the 4 filters suction in front of the cabinet, at the KI-Discus setup. Conclusion: We have less than 62 brown dots at each filter. age 8 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 9 Annex B 9.1 Normal conditions Under normal running conditions non-filtered air under positive pressure is encapsulated by surroundings negative pressure. Therefore positive pressure leaking to the surroundings under running conditions is only theoretical possible through sample port for DO testing. This sample port is double secured with both a valve and a silicone cap. 9.2 If MSC is turned off after use Soap solution test with an internal pressure at approximately 250 a and observe the soap applied. age 9 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 The Soap solution test was performed: By: Thomas Grau-Andersen Date: 20-08-2012 On L234 S/N: roto 2 Instrumentation: Soap solution The previous photos shows how soap solution is added to the cabinet. Conclusion: If the MSC is turned off nothing indicating leaks. 10 Annex C Downflow is measured by use of an anemometer. With the anemometer inside the MSC, make air velocity measurements in the horizontal plane 50 mm to 100 mm above the top edge of the front aperture. Make measurements over a period of at least 1 min in each position for at least eight positions. The exact height and placement can be seen in the tables(s) below. Inflow is measured by use of an anemometer. With the anemometer outside the MSC, make air velocity measurements pointing towards front opening. The exact height and placement can be seen in the tables(s) below. DO test (HEA filter test) is measured by use of an aerosol photometer. With this device test filters and edges along workspace filter and exhaust filter. If an aerosol photometer is used, the local penetration of a HEA filter should be not more than 0,01 %. Test results can be seen in the tables(s) below. age 10 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 age 11 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx
20 460 234 11 Annex D age 12 of 12 K:\UDVIKLING INF\rojekter\rojekt 55 L200 opdatering\analyse\l234 test report compliance to EN 12469.docx