Fon: ++49 (0) 70 71 / 857 893-100Fax: ++49 (0) 70 71 / 857 893 100 Email
[email protected] http: // www.smpgmbh.com SMP GmbH Service für Medizinprodukte Hechingerstrasse 262 • 72072 Tübingen 3URMHFW1R ,QYHVWLJDWLRQRIWKHFOHDQLQJ EHKDYLRU RIELSRODUPDUVHDO5() PP PDUVHDOKDQGOH5() PFDEOH &RPPLVVLRQHGE\ ./60DUWLQ*PE+&R.* $P*DQVDFNHUE 8PNLUFK .......................... Overview: ....................................................................................... Material and methods ......... 12 7.........................................................................................................................3 Run 3 (39/08) ....... 10 5...................................................6 Instruments under investigation.................................................................................................................................................................................................. 6 4............. 4 3.. 5 4.......................: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.... Results.. 7 4............................................ ............................................................................................. 80-630-02 and marseal handle Ref: 80630-09 page 2 from 10 Publications or copies are only allowed of the complete report... 15 Project No.......................................................................3 Cleaning ........2 Run 2 (34/08) .......... Appendix: Logger data...................................................................................................................... 7 5................................. 5 4.....................1 Run 1 (29/08) .................................5 Devices and reagents............................. 4 4..................... Objective of investigation ............. 3 2......1 Preparation of the test soil......................................................... 7 4................ein Projekt des in Kooperation m it 7DEOHRIFRQWHQWV 1.... 8 5.. 5 4................................................ 8 5.........................................4 Second Measurement with the Gamma camera ......... Conclusion ..................................................2 Contamination ....................................................................................................................................................... . 0DQXDOO\SUHFOHDQLQJ • Put the instruments in an ultrasonic bath for 5 minutes with 0. &RQFOXVLRQ The investigation shows that the handle and the tube of the bipolar MIC instrument “marSeal” can be successfully cleaned. The radionuclide method (RNM) is a non-destructive test procedure. that a coagulation of contaminated tissue after HF current impact does not cause a fixation of coagulated blood on the instrument. only the cleaning steps are performed): • 2 min pre-washing with cold water • emptying • 5 min washing with 0. residues can be made visible with the help of gamma radiation. . to evaluate the cleaning behavior of the bipolar marseal and marseal handle with the radionuclide method. The DYHUDJH of the detected contamination is ≤ 5 count/s. 80-630-02 and marseal handle Ref: 80630-09 page 4 from 10 Publications or copies are only allowed of the complete report. which allows the investigation of the cleaning behavior of tubular instruments and instruments with hidden corners.5 % neodischer Mediclean Forte (Dr.ein Projekt des in Kooperation m it .QYHVWLJDWLRQRIWKHFOHDQLQJEHKDYLRU 2EMHFWLYHRILQYHVWLJDWLRQ The objective of this experiment is. Weigert) at 40°C • All parts of the instruments are flushed with a water jet pistol with cold tap water for at least 10 sec. &OHDQLQJVWHSV For the cleaning procedure the instrument is dismantled. The instruments placed forceps upside show a slightly increase of contamination after cleaning.8 bar static water pressure) • Scrub thoroughly using a soft brush • Cleaning of forceps and hinge with special KLS Martin tool 5HSURFHVVLQJLQDZDVKHUGLVLQIHFWRU Connecting the instruments to the MIC-rack of the washer disinfector The instruments are cleaned with the following program (Vario TD. the size of the device and the way how it is been used. The exact distribution of the contamination can be checked and documented before and after cleaning. The basic idea is to label the test soil prior to the contamination of the instrument. For labeling macro albumins (known from the lung perfusion scintigraphy) with radioactive 99m Technetium (Tc-99m) are used and mixed with fresh coagulable blood. see chapter 5) is the threshold value for excellent cleaning results. which takes into consideration the amount of contamination and location before and after the cleaning process. Values above 5 counts/sec can be tolerable.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. (3. when a risk analysis is performed. After artificial contamination and cleaning of the inner surfaces of the instrument as well as of the outside. 5 counts/sec (Zr-value in tables of run 1 – 3. Test result in SMP investigation No:11107011407 show. Weigert)by 55°C • emptying Project No.5% neodischer Mediclean Forte (Dr. Contamination is performed in plastic cup filled with the test-soil (1). After 5 minutes coagulation is insisted. 80-630-02 and marseal handle Ref: 80630-09 page 5 from 10 Publications or copies are only allowed of the complete report. one tube with forceps up to simulate the worst case.9% sodiumchloride solution. which is connected with the handle.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. In the next step this tube is assembled with the handle to transfer the contamination inside the handle. Then the emission of the gamma quanta and the distribution on and inside the instruments are measured by a gamma camera.ein Projekt des • • • • in Kooperation m it 3 min neutralizing with warm water (>40°C) emptying 2 min intermediate rinsing with warm water (>40°C) emptying 0DWHULDODQGPHWKRGV 3UHSDUDWLRQRIWKHWHVWVRLO A flask Pulmocis is labelled by 400 MBq Technetium99m and filled up to the volume of 5 mL with 0. is contaminated by touching with contaminated gloves. Heparinized sheep blood and protaminsulfat is added. After the contamination. Additional the part of this tube. The instruments are submerged into the test-soil up to the hinge of the forceps (2). In this position it is possible for the test soil to get inside the tube. 2 1 Figure 1: Example of the contamination procedure Project No. In this position the forceps are affected 3 times.9 mL) • 150 µL Protaminsulfat &RQWDPLQDWLRQ 5 devices are marked with different colors. the tubes are placed in a basket: 4 of the five tubes with forceps down. . the instruments dried for 1 hour at room temperature. Mixing ratio of the test soil ingredients: • 9 mL heparinized sheep blood (Acila GMN) • 100 MBq Technetium99m (~ 0. 80-630-02 and marseal handle Ref: 80630-09 page 6 from 10 Publications or copies are only allowed of the complete report. &OHDQLQJVWHSV For the cleaning procedure the instrument is dismantled.ein Projekt des in Kooperation m it &OHDQLQJ The cleaning process starts 60 minutes after the contamination of the instruments.5% neodischer Mediclean Forte (Dr. Weigert) at 40°C • All parts of the instruments are flushed with a water jet pistol with cold tap water for at least 10 sec.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.5 % neodischer Mediclean Forte (Dr.8 bar static water pressure) • Scrub thoroughly using a soft brush • Cleaning of forceps and hinge with special KLS Martin tool 5HSURFHVVLQJLQDZDVKHUGLVLQIHFWRU Connecting the instruments to the MIC-rack of the washer disinfector The instruments are cleaned with the following program (Vario TD. Weigert)by 55°C • emptying • 3 min neutralizing with warm water (>40°C) • emptying • 2 min intermediate rinsing with warm water (>40°C) • emptying Project No. (3. . 0DQXDOO\SUHFOHDQLQJ • Put the instruments in an ultrasonic bath for 5 minutes with 0. only the cleaning steps are performed): • 2 min pre-washing with cold water • emptying • 5 min washing with 0. neodischer Mediclean Forte (Dr.washer disinfector (Miele) . Regions of interest (ROI) are defined to allow subsequent determination of exact areas of residual contamination in the individual instruments.MIC rack (E 450) .QVWUXPHQWVXQGHULQYHVWLJDWLRQ For the investigation five instruments are used.Beaker .Curiementor-E (Semens) .01 h) 'HYLFHVDQGUHDJHQWV .Ultrasonic bath Sonorex (Bandein) . Zr: counts/sec with correction of time-dependent gamma decay of metastable technetium 99 (half-life 6. Only the Zr value given in the table is used for the evaluation of the residual contamination.Syringe .Pulmocis (CIS bio international) . the instruments are measured again using the gamma camera.gloves (Satin plus. Weigert) . or which are recorded during the test and which serve only as a basis for the calculation of the Zr value.ein Projekt des in Kooperation m it 6HFRQG0HDVXUHPHQWZLWKWKH*DPPDFDPHUD After cleaning.Technetium99m .magnetic stirrer . The other values are data recorded by the camera. The results are documented and residual contamination is determined on the basis of the remaining activity. 80-630-02 and marseal handle Ref: 80630-09 page 7 from 10 Publications or copies are only allowed of the complete report.Data logger for temperature and pressure Ebi -125A-PT (Ebro) .Protaminsulfat (Acila GMN) .heparinised sheep blood Lot: 18477 (Acila GMN) .gamma camera (Gaede GMS 586) . Inner shaft marseal Instrument Handle Figure 2 bipolar marseal Ref: 80-630-02 370 mm marseal handle Ref: 80-630-09 Project No. Safe skin) .: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. . ein Projekt des in Kooperation m it 5HVXOWV 5XQ . 3. . Instruments have been washed with a procedure described under 4. )* + ..-/. .=6>!20! ? "g * h #i0 6hjk:GGlBV @<A=>< B+ "CD@! )!* 0 $3(6!EE$!F GH D&!I ! ) * 0 D '>+ P#"10</J2! : Q. J * =&0</6! )K1L 0<EMN< /&6 *(K!O J/7 '> :0&/D0 5* Y /=BJ< ."10&2 :0 ) 7 1<. :0&/D0 * 2D@ :0&/D0 * ! > 2 :0&/D0 *5 O * J :0&/D0 * 8 * * 6 L . :0&/D0 5* Y /=BJ< .0&/D0 `* L 7 E 70 '@ * 70 '@ * b2D@ 70 '@ * O * J 70 '@ * $>!2 70 '@ * 1 8 * * 6 L 70 '@ * L 7 E #"10</J2! : Q. 4 0 150 [] 7848 299 1. * * / W3 I PX'2 E6 T 8150 264 1.4 128 150 .4 5 150 [] 3973 3243 1.4 0 150 Z\] 2860 299 1. * * / 84 210 1.4 5 150 cZ 2841 3243 1.4 128 150 103 1251 1.4 0 150 Z9^!_ 7487 299 1.4 5 150 [ W3 I PX'2 E6 T \ R ) = S< 8UT!> after pre-cleaning V.4 5 150 [d 2001 3243 1.4 128 150 \ :0&/D0 * 8 * * 6 L !/70<eA 89 1251 1.4 5 150 ]'^ 465 3174 1.4 0 150 Z]a 3001 3174 1.4 128 150 162 210 1. :0&/D0 * 2D@ !/70<eA :0&/D0 * >!2 !/70<eA !#"$&%'( R ) = S< 8UT!> 3#546'/7980 after contamination V.4 0 150 Z[\ 6608 264 1.4 128 150 Z ^ 195 189 1.4 128 150 d 109 210 1.4 128 150 :0&/D0 5* O* J !/70<eA 83 1251 1. .4 132 150 ] 280 3243 1.4 128 150 266 189 1. 80-630-02 and marseal handle Ref: 80630-09 page 8 from 10 Publications or copies are only allowed of the complete report.4 132 150 ] 251 3243 1.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.4 132 150 303 3243 1.0&/D0 `* L 7 E !/70<eA 96 1251 1.4 128 150 \ 339 3174 1.4 132 150 \ f eNeE 70 '@ * b2D@ 70 '@ * O * J 70 '@ * $>!2 70 '@ * 1 8 * * 6 L 70 '@ * L 7 E Z ^ Z ^ Project No.4 128 150 _ 131 1251 1.4 132 150 ] 303 3243 1. ein Projekt des m!n5oCpq<rst&p!u:pvw u:qtErDpqx5y vrw=t s<u:pvw u. qtErDpqxzt2pD{ } vvpt!r~qNw u:qtErDpqx!t2ppv } vvpt!r~qNw u. qt&rDpqx5x sp } vvpt!r~qNw u. qtErDpqx`px x
} vvpt!r~qNw u:qt&rDpqx`:~} wAp } vvpt!r~qNw tB} AAp ~qv'{!x p. 4 176 150 242 3243 1.4 172 150 115 1341 1.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.4 172 150 | 310 3174 1.4 172 150 246 230 1.4 172 150 104 230 1. In this position it is possible for the test soil to get inside the tube.4 176 150 271 3243 1.4 172 150 104 230 1.4 176 150 | 230 3243 1.4 176 150 | 237 3243 1.4 172 150 134 1341 1.(see chapter 4.4 176 150 | | | 1RWRI5XQ Instrument white to simulate the worst case.4 172 150 150 230 1.4 172 150 90 1341 1. 80-630-02 and marseal handle Ref: 80630-09 page 9 from 10 Publications or copies are only allowed of the complete report.2) Project No.4 172 150 109 1341 1. .t2pD{ ~qv'{!x pbx sp ~qv'{!x p!t2ppv ~qv<{!x ph9px x
~qv'{!x ph:~D} wEp in Kooperation m it after cleaning | 73 230 1.4 172 150 95 1341 1. in Kooperation m it ein Projekt des 5XQ . 3. Instruments have been washed with a procedure described under 4. : '< ¤¥ ¦ §.¨©. ¡ º ¥ = &ª©!°! ¤»1¼ ª<E½A< ©&° ¥(»!¾ Bº© ® '± :ª&©Dª ¥ « ©=Bº<.=°±!2ª!? ¢g ¥ h#Õª °hÖ×:··ØBà ²#¡5³°'© ®9´ ª µ<A=±<B¦ ¢CDµ! ¤!¥ ª$²(°!EED¶ ·¸ D&!¹ ! ¤ ¥ ª '±¦ ¡#¢1ª<©º2!: ¿.¢1ª&2 « ¡ ¬ª ¥ £ :ª ¤!® 1<¯. :ª&©Dª ¥ 2Dµ :ª&©Dª ¥ ! ± 2 :ª&©Dª ¥5 ¾ ¥ º :ª&©Dª ¥`´ ¥ ¥ ° ¼ . ª&©Dª `¥ ¼Ï® E ® ª'µ ¥ ª 'µ ¥ b2Dµ ® ® ª'µ ¥ ¾ ¥ º' ª ' µ $ ! ± 2 ® ¥ ® ª'µ ¥ ´ ¥ ¥ ° ¼ ® ª'µ ¥ ¼Ï® E Ñ¡#¢1ª<©º2!: ¿. ¡ :ª&©Dª ¥ « ©=Bº<. :ª&©Dª ¥ 2Dµ !© ® ª<ÒA :ª&©Dª ¥ ±!2 !© ® ª<ÒA :ª&©Dª ¥5¾¥ º !© ® ª<ÒA :ª&©Dª `¥ ´ ¥ ¥ ° ¼ !© ® ª<AÒ . : 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.4 112 150 466 3712 1. 80-630-02 and marseal handle Ref: 80630-09 page 10 from 10 Publications or copies are only allowed of the complete report.4 0 150 ÊÌ 3624 276 1.4 0 150 ÎÇ 3709 3519 1.4 4 150 ÍÊ 3374 3519 1.4 108 150 Ç 242 3519 1.4 4 150 ÍÐ Ã ¥ ¥ © ÄŲ N¹ = Æ'= &°  386 160 1.4 108 150 210 144 1.4 108 150 96 160 1.4 112 150 Ô Ê Ç É Ç É È Project No.4 4 150 ÊÐ 3544 3640 1.4 108 150 É 75 952 1.4 108 150 Ì 97 144 1.4 108 150 87 952 1.4 108 150 84 1071 1.4 4 150 ÍÉ 6999 3712 1.4 108 150 Ð 3919 À ¤ = Á< ´U ± after pre-cleaning Ç 86 1071 1.4 108 150 Ê 61 952 1.4 108 150 235 144 1.4 112 150 388 3640 1.4 4 150 ÇÉÎ 3519 1.4 0 150 ÍÎ 3831 299 1. .4 112 150 Í 332 3519 1.4 0 150 Ç9È!É 3120 288 1.4 112 150 Ç 261 3519 1.ª&©Dª `¥ ¼Ï® E !© ® ª<ÒA Ó ÒNÒE ª 'µ ¥ b2Dµ ® ® ª'µ ¥ ¾ ¥ º' ª ' µ $ ! ± 2 ® ¥ ® ª'µ ¥ ´ ¥ ¥ ° ¼ ® ª'µ ¥ Ï ¼ ® E À ¤ = Á< ´U ± after contamination !¡5¢g&£'¡( à ¥ ¥ © ÄŲ N¹ = Æ'= &°  7610 288 1.4 0 150 ÊË 2689 299 1. ein Projekt des ÙÚ#Û1ÜÝ<Þßà2Ü!á:Üâã á:Ýà&ÞDÜÝä5å âÞã=àBß<á. Üâã á:Ýà&ÞDÜÝäæà2ÜDç é ââÜà!ÞêÝ<ëAã á:Ýà&ÞDÜÝä(í!à2ÜÜâ é ââÜà!ÞêÝ<ëAã á:Ýà&ÞDÜÝä5ïä ßÜ é ââÜà!ÞêÝ<ëAã á:Ýà&ÞDÜÝä`ñÜä ä òó é ââÜà!ÞêÝ<ëAã á. Ýà&ÞDÜÝä`óÏêé ãEÜ é ââÜà!ÞêÝ<ëAã ô à é ëNëEÜ êÝâ'ç!ä Übà2ÜDç êÝâ'ç!ä Ü. 4 121 150 91 1053 1.4 125 150 è 332 3712 1.4 121 150 ð 123 198 1.4 121 150 ì 84 1170 1.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.4 121 è 150 ì 89 1170 1. In this position it is possible for the test soil to get inside the tube.(see chapter 4.4 121 150 è 83 1053 1. 80-630-02 and marseal handle Ref: 80630-09 page 11 from 10 Publications or copies are only allowed of the complete report.4 125 150 è 274 3519 1.ïä ß'Ü êÝâ'ç!ä Ü$í!à2ÜÜâ êÝâ'ç!ä Ü1ñÜä ä òó êÝâ'çä Ü1óÏêé ãEÜ in Kooperation m it after cleaning 123 198 1.4 125 150 î 321 3640 1.4 121 150 ì 101 1053 1.4 121 150 ì 49 198 1.4 125 150 î î 1RWRI5XQ Instrument red to simulate the worst case.4 121 150 ì 56 176 1. .4 121 150 107 198 1.4 121 150 ì 220 3519 1.4 125 150 ì 277 3519 1.2) Project No. in Kooperation m it ein Projekt des 5XQ . ¨©. Instruments have been washed with a procedure described under 4.3. : õ ¤¥ ¦ §. ¢1ª&2 « ¡ ¬ª ¥ £ :ª ¤!® 1<¯.=°±!2ª!? ¢g ¥ h#Õª °hÖ×:··ØBà ²#¡5³°'© ®9´ ª µ<A=±<B¦ ¢CDµ! ¤!¥ ª$²(°!EED¶ ·¸ D&!¹ ! ¤ ¥ ª '±¦ ¡#¢1ª<©º2!: ¿. ¡ º ¥ = &ª©!°! ¤»1¼ ª<E½A< ©&° ¥(»!¾ Bº© ® '± :ª&©Dª ¥ « ©=Bº<. :ª&©Dª ¥ 2Dµ :ª&©Dª ¥ ! ± 2 :ª&©Dª ¥5 ¾ ¥ º :ª&©Dª ¥`´ ¥ ¥ ° ¼ . ¡ :ª&©Dª ¥ « ©=Bº<.ª&©Dª `¥ ¼Ï® E ® ª'µ ¥ ª 'µ ¥ b2Dµ ® ® ª'µ ¥ ¾ ¥ º' ª ' µ $ ! ± 2 ® ¥ ® ª'µ ¥ ´ ¥ ¥ ° ¼ ® ª'µ ¥ ¼Ï® E Ñ¡#¢1ª<©º2!: ¿. :ª&©Dª ¥ 2Dµ !© ® ª<ÒA :ª&©Dª ¥ ±!2 !© ® ª<ÒA :ª&©Dª ¥5¾¥ º !© ® ª<ÒA :ª&©Dª `¥ ´ ¥ ¥ ° ¼ !© ® ª<AÒ . .4 86 150 Î 67 882 1.4 0 150 ËÇ 6290 312 1.4 86 150 Ì 90 200 1.4 86 150 Î 63 882 1.4 0 150 ÇÇÔ 7065 312 1.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.4 86 150 Ë 882 1.4 0 150 ÇÉÌ 4347 288 1.4 86 150 É 71 882 1.4 96 150 É 516 3082 1.4 86 150 200 1.4 0 150 ÇÔÇ 6441 288 1.4 86 150 Ì 391 180 1.4 5 150 ÊÔ 3128 1. 80-630-02 and marseal handle Ref: 80630-09 page 12 from 10 Publications or copies are only allowed of the complete report.4 5 150 ËÊ 3845 3082 1.4 86 150 Ì 314 3082 1.4 96 150 Ë Ç 87 311 Project No.4 5 150 ÇÔÇ 4705 3128 1.4 86 150 Ì 346 180 1.4 96 150 Ô 286 3128 1.ª&©Dª `¥ ¼Ï® E !© ® ª<ÒA Ó ÒNÒE ª 'µ ¥ b2Dµ ® ® ª'µ ¥ ¾ ¥ º' ª ' µ $ ! ± 2 ® ¥ ® ª'µ ¥ ´ ¥ ¥ ° ¼ ® ª'µ ¥ Ï ¼ ® E À ¤ = Á< ´U ± after contamination !¡5¢g&£'¡( à ¥ ¥ © ÄŲ N¹ = Æ'= &°  6073 288 1.4 5 150 ËÉ Ã ¥ ¥ © ÄŲ N¹ = Æ'= &°  180 1.4 0 150 ÇÇÎ 7149 3082 1.4 5 150 ÍÐ 2999 3082 1.4 86 150 Í 4538 À ¤ = Á< ´U ± 307 after pre-cleaning 61 882 1.4 96 150 É 275 3082 1.4 96 150 É 283 3082 1. ein Projekt des ÙÚ#Û1ÜÝ<Þßà2Ü!á:Üâã á:Ýà&ÞDÜÝä5å âÞã=àBß<á. Üâã á:Ýà&ÞDÜÝäæà2ÜDç é ââÜà!ÞêÝ<ëAã á:Ýà&ÞDÜÝä(í!à2ÜÜâ é ââÜà!ÞêÝ<ëAã á:Ýà&ÞDÜÝä5ïä ßÜ é ââÜà!ÞêÝ<ëAã á:Ýà&ÞDÜÝä`ñÜä ä òó é ââÜà!ÞêÝ<ëAã á. Ýà&ÞDÜÝä`óÏêé ãEÜ é ââÜà!ÞêÝ<ëAã ô à é ëNëEÜ êÝâ'ç!ä Übà2ÜDç êÝâ'ç!ä Ü. 4 131 150 ð 275 180 1.4 135 150 è 314 3082 1.4 135 150 è 267 3128 1.4 135 150 ì ì ù 1RWRI5XQ Instrument yellow to simulate the worst case.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref.4 131 150 239 200 1. .2) Project No.4 131 150 ö 61 882 1.(see chapter 4.4 131 150 ÷ 47 882 1. 80-630-02 and marseal handle Ref: 80630-09 page 13 from 10 Publications or copies are only allowed of the complete report.ïä ß'Ü êÝâ'ç!ä Ü$í!à2ÜÜâ êÝâ'ç!ä Ü1ñÜä ä òó êÝâ'çä Ü1óÏêé ãEÜ in Kooperation m it after cleaning 291 180 1.4 131 150 ø 50 882 1.4 131 150 ð 83 180 1.4 135 150 î 274 3082 1.4 131 150 285 3082 1. In this position it is possible for the test soil to get inside the tube.4 131 150 î 75 882 1.4 131 150 ÷ 68 882 1.4 131 150 ð 223 180 1.4 135 150 î 261 3082 1. terms and definitions and tests. Washer/-disinfectors . acceptance criteria for cleaning reusable medical devices ISO 17664 Publication date:2004-03 Sterilization of medical devices . utensils. References: ú û<ü<ýþ2ÿ 2ÿ 5þ=ÿ ý ÿ þ ü Draft “Standard Test Method for Validation of cleaning cycles for reusable medical devices with lumens and hidden surfaces“. TIR 30 TIR 30 “A compendium of processes. German version EN ISO 158832:2006 Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. materials. test methods. German version EN ISO 15883-1:2006 EN ISO 15883-2:2006 Publication date:2006 Washer/-disinfectors . . dishes receivers. This test method is under the jurisdiction of ASTM Committee F04 Medical and Surgical Devices and is the direct responsibility of Subcommittee F04. etc.Part 1: General requirements. 80-630-02 and marseal handle Ref: 80630-09 page 14 from 10 Publications or copies are only allowed of the complete report.ein Projekt des in Kooperation m it 6. (ISO 15883-2:2006).Information to be provided by the manufacturer for the processing of resterilizable medical devices EN ISO 15883-1:2006 Publication date:2006.35 GI Endoscopes. bowls.Part 2: Requirements and tests for washer/disinfectors employing thermal disinfection for surgical instruments. anaesthetic equipment. glassware. 3: Pressure and temperature logger diagram Project No.ein Projekt des in Kooperation m it $SSHQGL[ /RJJHUGDWD Fig. . 80-630-02 and marseal handle Ref: 80630-09 page 15 from 10 Publications or copies are only allowed of the complete report.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. +39 039 605 67 31
[email protected] KLS Martin France SARL 68000 Colmar France Tel. +81 6 62 28 90 75 nippon@klsmartin. Osaka 541-0046 Japan Tel.com Orthosurgical Implants Inc. +49 74 63 838-0
[email protected] Nippon Martin K.l.com Gebrüder Martin GmbH & Co.com 04. Jacksonville.com Martin Italia S. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin. +49 76 65 98 02-0
[email protected] Martin Group Karl Leibinger GmbH & Co.r.klsmartin. Miami. 1270 AG Huizen The Netherlands Tel. Fl 32246 USA Office Phone +1 904 641 77 46 usa@klsmartin. +49 74 63 99 516-30
[email protected] Gebrüder Martin GmbH & Co.P.com KLS Martin L.com Martin Nederland/Marned B. KG A company of the KLS Martin Group Ludwigstaler Straße 132 · D-78532 Tuttlingen Postfach 60 · D-78501 Tuttlingen/Germany Tel. Fl 33186 USA Office Phone +1 877 969 45 45
[email protected] Stuckenbrock Medizintechnik GmbH 78532 Tuttlingen Germany Tel. KG 78570 Mühlheim Germany Tel. KG Representative Office 121471 Moscow Russia Tel. +31 35 523 45 38
[email protected] · www. KG · Alle Rechte vorbehalten · Technische Änderungen vorbehalten We reserve the right to make alterations · Cambios técnicos reservados · Sous réserve de modifications techniques · Ci riserviamo il diritto di modifiche tecniche . +49 74 61 16 11 14
[email protected]. 20059 Vimercate (MB) Italy Tel.de KLS Martin GmbH & Co. +33 3 89 21 66 01
[email protected] Rudolf Buck GmbH 78570 Mühlheim Germany Tel.08 · 90-335-82-04 · Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG 79224 Umkirch Germany Tel. +7 (499) 792-76-19 russia@klsmartin.