{"id":3054,"date":"2020-05-06T10:08:18","date_gmt":"2020-05-06T07:08:18","guid":{"rendered":"https:\/\/www.medibim.com.tr\/TR\/?p=3054"},"modified":"2023-10-20T18:30:50","modified_gmt":"2023-10-20T15:30:50","slug":"turkak-akreditasyon-kapsami","status":"publish","type":"post","link":"https:\/\/www.medibim.com.tr\/TR\/kurumsal\/turkak-akreditasyon-kapsami\/","title":{"rendered":"T\u00fcrkak Akreditasyon Kapsam\u0131"},"content":{"rendered":"\n

T\u00fcrkak Akreditasyon Kapsam\u0131<\/p>\n

G\u00fcncellenmi\u015f T\u00fcrkak Akreditasyon Kapsam\u0131 a\u015fa\u011f\u0131daki gibidir.<\/p>\n

T\u00fcrkak sitesi linki i\u00e7in -> t\u0131klay\u0131n\u0131z<\/a>.<\/p>\n

Medibim;\u00a0 medikal cihazlar\u0131n performans testleri, kalibrasyonlar\u0131 ve t\u0131bbi cihazlar\u0131n CE belgelendirmeleri i\u00e7in gerekli tip tayin testlerini T\u00fcrkak Akreditasyon kapsam\u0131 dahilinde hizmet olarak vermektedir.<\/p>\n

T\u00fcrkak Akreditasyon Kapsam\u0131<\/span><\/h2>\n
\n\n\n\n\n\n\n\n\n
MED\u0130B\u0130M Medikal Bili\u015fim Kalibrasyon San. Tic. Ltd. \u015eti.<\/th>\n<\/tr>\n
Adres<\/th>\nG\u00fczelyurt Mh. Mehmet Akif Ersoy Cad. G\u00f6kdemir Plaza No:38 Kat:2 No:10 ESENYURT \u0130STANBUL<\/td>\n<\/tr>\n
Telefon<\/th>\n0 212 438 20 46 47<\/td>\n<\/tr>\n
Standart<\/th>\nTS EN ISO\/IEC 17025:2017<\/td>\n<\/tr>\n
Akreditasyon Tarihi<\/th>\n20.04.2018<\/td>\n<\/tr>\n
Dosya No<\/th>\nAB-1251-T<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Deneyi Yap\u0131lan Malzemeler \/ \u00dcr\u00fcnler<\/th>\nDeney Ad\u0131<\/th>\nDeney Metodu (Ulusal, uluslararas\u0131 standardlar, \u0130\u015fletme i\u00e7i metodlar)<\/th>\n<\/tr>\n
Elektrikli T\u0131bbi Donan\u0131m<\/td>\nElektrikli t\u0131bbi donan\u0131m-B\u00f6l\u00fcm 1: Temel g\u00fcvenlik ve gerekli performans i\u00e7in genel kurallar.<\/td>\nTS EN IEC 60601-1
TS EN IEC 62353<\/td>\n<\/tr>\n
\u00a0<\/td>\nKoruyucu Topraklama Direnci<\/td>\nTS EN 60601 (Madde 8.6.4)
TS EN 62323 (Madde 5.3.2)<\/td>\n<\/tr>\n
\u00a0<\/td>\nTopraklama Ka\u00e7ak Ak\u0131m\u0131<\/td>\nTS EN 60601 (Madde 8.7.4.5)<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u0130zolasyon Direnci<\/td>\nTS EN ISO 62353 (Madde 5.3.4)<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u015ease Ka\u00e7ak Ak\u0131m\u0131<\/td>\nTS EN 60601 (Madde 8.7.4.6)
TS EN 62353 (Madde 5.3.3.3.2, 5.3.3.3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\nHasta Ka\u00e7ak Ak\u0131m\u0131<\/td>\nTS EN 60601 (Madde 8.7.4.7)
TS EN 62353 (Madde 5.3.3.3.2, 5.3.3.3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\nHasta Yard\u0131mc\u0131 Ka\u00e7ak Ak\u0131m\u0131<\/td>\nTS EN 60601 (Madde 8.7.4.8)
TS EN 62353 (Madde 5.3.3.3.2, 5.3.3.3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\nUygulama Par\u00e7alar\u0131nda Ka\u00e7ak Ak\u0131m\u0131<\/td>\nTS EN 60601 (Madde 8.7.4.7.g)
TS EN 62353 (Madde 5.3.3.3.2, 5.3.3.3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u015eebeke Gerilimi<\/td>\nTS EN 60601 (Madde 8.5.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\nCihaz Toplam Ka\u00e7ak Ak\u0131m\u0131<\/td>\nTS EN 62353 (Madde 5.3.3.3.2, 5.3.3.3.3)<\/td>\n<\/tr>\n
Hastaba\u015f\u0131 Monit\u00f6r\u00fc<\/td>\nElektrikli T\u0131bbi Donan\u0131m – B\u00f6l\u00fcm 2-27: Elektrokardiyografik izleme donan\u0131m\u0131n\u0131n gerekli performans\u0131 ve g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 60601-2-27
EN 60601-2-27
IEC 60601-2-27<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Nab\u0131z Testi<\/td>\nMadde 201.12.1.101.15<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Genlik Testi<\/td>\nMadde 201.12.1.101.16<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Frekans Testi<\/td>\nMadde 201.12.1.101.8<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Aritmi Testi<\/td>\nMadde 208.6.6.103<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG ST Testi<\/td>\nMadde 201.12.1.101.13<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Yaz\u0131c\u0131 ve Ka\u011f\u0131t H\u0131z\u0131 Testi<\/td>\nMadde 201.12.1.101.7<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Alarm Testi<\/td>\nMadde 208.6.6.2.103<\/td>\n<\/tr>\n
\u00a0<\/td>\nSolunum Performans Testi<\/td>\nMadde 208.6.3.3.1<\/td>\n<\/tr>\n
\u00a0<\/td>\nSolunum Alarm Testi<\/td>\nMadde 208.6.6.2.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nElektrikli t\u0131bbi cihazlar B\u00f6l\u00fcm 2-34: Giri\u015fimsel kan bas\u0131nc\u0131 izleme donan\u0131m\u0131n\u0131n gerekli performans\u0131 d\u00e2hil g\u00fcvenli\u011fi i\u00e7in \u00f6zel kurallar<\/td>\nTS EN 60601-2-34
EN 60601-2-34
IEC 60601-2-34<\/td>\n<\/tr>\n
\u00a0<\/td>\nIBP Statik Bas\u0131n\u00e7 Testi<\/td>\nMadde 201.12.1.101.1<\/td>\n<\/tr>\n
\u00a0<\/td>\nIBP Dinamik Bas\u0131n\u00e7 Testi<\/td>\nMadde 201.12.1.101.2<\/td>\n<\/tr>\n
\u00a0<\/td>\nIBP Alarm Testi<\/td>\nMadde 208.6<\/td>\n<\/tr>\n
\u00a0<\/td>\nElektrikli t\u0131bbi donan\u0131m B\u00f6l\u00fcm 2-30: Giri\u015fimsel olmayan otomatik tekrarl\u0131 kan bas\u0131nc\u0131 izleme donan\u0131m\u0131n\u0131n gerekli performans\u0131 d\u00e2hil g\u00fcvenlik i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 80601-2-30
EN 80601-2-30<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Performans Testi<\/td>\nMadde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Man\u015fon maksimum -Bas\u0131n\u00e7 Testi<\/td>\nMadde 201.104<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Man\u015fon Bas\u0131n\u00e7 Ka\u00e7ak Testi<\/td>\nMadde 201.12.3.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Alarm Testi<\/td>\nMadde 201.12.1.101.1<\/td>\n<\/tr>\n
\u00a0<\/td>\nElektrikli t\u0131bbi donan\u0131m B\u00f6l\u00fcm 2-61: \u0130\u00e7in nab\u0131z oksimetre donan\u0131m\u0131n\u0131n gerekli performans\u0131 ve temel g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN ISO 80601-2-61
EN ISO 80601-2-61<\/td>\n<\/tr>\n
\u00a0<\/td>\nSPO2 Performans Testi<\/td>\nMadde 201.12.1.104<\/td>\n<\/tr>\n
\u00a0<\/td>\nSPO2 Alarm Testi<\/td>\nMadde 208.6.1.2.101<\/td>\n<\/tr>\n
Defibrilat\u00f6rler (Monit\u00f6rl\u00fc ve\/veya monit\u00f6rs\u00fcz)<\/td>\nElektrikli T\u0131bbi Donan\u0131m B\u00f6l\u00fcm 2-27: Elektrokardiyografik izleme donan\u0131m\u0131n\u0131n gerekli performans\u0131 ve g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 60601-2-27
EN 60601-2-27<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Nab\u0131z Testi<\/td>\nMadde 201.12.1.101.15<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Genlik Testi<\/td>\nMadde 201.12.1.101.16<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Frekans Testi<\/td>\nMadde 201.12.1.101.8<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Aritmi Testi<\/td>\nMadde 208.6.6.103<\/td>\n<\/tr>\n
\u00a0<\/td>\nEnerji Testi<\/td>\nMadde 50.2<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u015earj Zaman\u0131 Testi<\/td>\nMadde 102.6<\/td>\n<\/tr>\n
\u00a0<\/td>\nSenkronize De\u015farj Testi<\/td>\nMadde 104<\/td>\n<\/tr>\n
\u00a0<\/td>\nElektrikli t\u0131bbi donan\u0131mlar – B\u00f6l\u00fcm 2-31: Kalp defibrilat\u00f6rlerinin (Pacemaker) g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler.<\/td>\nTS EN 60601-2-4
EN 60601-2-4
IEC 60601-2-4<\/td>\n<\/tr>\n
Elektrokardiyograf (EKG) \u0130zleme Cihazlar\u0131<\/td>\nElektrikli T\u0131bbi Donan\u0131m B\u00f6l\u00fcm 2-27: Elektrokardiyografik izleme donan\u0131m\u0131n\u0131n gerekli performans\u0131 ve g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 60601-2-27
EN 60601-2-27
IEC 60601-2-27<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Nab\u0131z Testi<\/td>\nMadde 201.12.1.101.15<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Genlik Testi<\/td>\nMadde 201.12.1.101.16<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Frekans Testi<\/td>\nMadde 201.12.1.101.8<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Aritmi Testi<\/td>\nMadde 208.6.6.103<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG ST Testi<\/td>\nMadde 201.12.1.101.13<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Alarm Testi<\/td>\nMadde 201.12.1.101.7<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Yaz\u0131c\u0131 ve Ka\u011f\u0131t H\u0131z\u0131 Testi<\/td>\nMadde 208.6.6.2.103<\/td>\n<\/tr>\n
Oksimetre (Pulsoksimetre\/SPO2) \u0130zleme Cihazlar\u0131<\/td>\nElektrikli t\u0131bbi donan\u0131m -B\u00f6l\u00fcm 2-61: \u0130\u00e7in nab\u0131z oksimetre donan\u0131m\u0131n\u0131n gerekli performans\u0131 ve temel g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 80601-2-61
EN 80601-2-61<\/td>\n<\/tr>\n
\u00a0<\/td>\nSPO2 Performans Testi<\/td>\nMadde 201.12.1.104<\/td>\n<\/tr>\n
\u00a0<\/td>\nSPO2 Alarm Testi<\/td>\nMadde 208.6.1.2.101<\/td>\n<\/tr>\n
Giri\u015fimsel Olmayan Otomatik Tekrarl\u0131 Kan Bas\u0131nc\u0131 (NIBP) Cihazlar\u0131<\/td>\nElektrikli t\u0131bbi donan\u0131m – B\u00f6l\u00fcm 2-30: Giri\u015fimsel olmayan otomatik tekrarl\u0131 kan bas\u0131nc\u0131 izleme donan\u0131m\u0131n\u0131n gerekli performans\u0131 d\u00e2hil g\u00fcvenlik i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 80601-2-30
EN 80601-2-30<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Performans Testi<\/td>\nMadde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Man\u015fon Maksimum Bas\u0131n\u00e7 Testi<\/td>\nMadde 201.104<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Man\u015fon Bas\u0131n\u00e7 Ka\u00e7ak Testi<\/td>\nMadde 201.12.3.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nNIBP Alarm Testi<\/td>\nMadde 201.12.1.101.1<\/td>\n<\/tr>\n
\n

Giri\u015fimsel Olmayan Analog Tansiyon Aletleri G\u00fcvenlik ve Performans Testleri<\/span><\/p>\n<\/td>\n

\u0130nvaziv olmayan tansiyon aletleri-B\u00f6l\u00fcm 1: Genel \u00d6zellikler<\/td>\nTS EN 81060-1
EN 81060-1<\/td>\n<\/tr>\n
\u00a0<\/td>\nSistem Ka\u00e7ak Testi<\/td>\nMadde 7.2.1<\/td>\n<\/tr>\n
\u00a0<\/td>\nG\u00f6sterge Do\u011frulu\u011fu Testi<\/td>\nMadde 7.1.1<\/td>\n<\/tr>\n
Elektrokoterler (Elektrocerrahi Cihazlar)<\/td>\nElektrikli t\u0131bbi donan\u0131m -B\u00f6l\u00fcm 2 -2: Y\u00fcksek frekansl\u0131 cerrahi ve y\u00fcksek frekansl\u0131 cerrahi aksesuarlar\u0131n temel g\u00fcvenli\u011fi ve gerekli performans\u0131 i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 60601-2-2
EN 60601-2-2
IEC 60601-2-2<\/td>\n<\/tr>\n
\u00a0<\/td>\nG\u00fc\u00e7 Da\u011f\u0131l\u0131m\u0131 Testi<\/td>\nMadde 201.7.9.3.1
Madde 201.12.1<\/td>\n<\/tr>\n
\u00a0<\/td>\nHF Ka\u00e7ak Testi<\/td>\nMadde 201.8.7.3.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nREM Alarm-Dispersif Elektrod Kontak Kalitesi Testi<\/td>\nMadde 59.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nAktif ve Dispersive Elektrod \u0130zolasyonu Testi<\/td>\nMadde 201.8.8.3.101<\/td>\n<\/tr>\n
Anestezi ve Yo\u011fun Bak\u0131m Suni Solunum Cihaz\u0131 – Ventilat\u00f6rler<\/td>\nElektrikli t\u0131bbi donan\u0131m – B\u00f6l\u00fcm 2-12: Akci\u011fer ventilat\u00f6rlerinin g\u00fcvenli\u011fi i\u00e7in belirli \u00f6zellikler Yo\u011fun bak\u0131m vantilat\u00f6rleri<\/td>\nTS EN 80601-2-12
IEC 80601-2-12
TS EN 80601-2-12<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u0130nspirasyon Tepe Bas\u0131nc\u0131(PIP) Performans Testi<\/td>\nMadde 201.12.4.105<\/td>\n<\/tr>\n
\u00a0<\/td>\nEkspirasyon Sonu Pozitif Bas\u0131n\u00e7(PEEP) Testi<\/td>\nMadde 201.12.1.101
Madde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nOrtalama Solunum Yolu Bas\u0131n\u00e7 Testi<\/td>\nMadde 201.12.4.102<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u0130nspirasyon Pauz Bas\u0131nc\u0131 Testi<\/td>\nMadde 201.12.4.102
Madde 201.107.2<\/td>\n<\/tr>\n
\u00a0<\/td>\nLimit Bas\u0131n\u00e7 Testi<\/td>\nMadde 201.12.4.105<\/td>\n<\/tr>\n
\u00a0<\/td>\nTidal Hacim (TV) Testi<\/td>\nMadde 201.12.4.103.1
Madde 201.12.4.103.2<\/td>\n<\/tr>\n
\u00a0<\/td>\nHacim Kontroll\u00fc Ventilasyon Testi<\/td>\nMadde 201.12.1.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nBas\u0131n\u00e7 Kontroll\u00fc Ventilasyon Testi<\/td>\nMadde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u0130nspirasyon Hacimsel Tepe Ak\u0131\u015f H\u0131z\u0131 Testi<\/td>\nMadde 201.12.1.101
Madde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nEkspirasyon Hacimsel Tepe Ak\u0131\u015f H\u0131z\u0131 Testi<\/td>\nMadde 201.12.1.101
Madde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nSolunum H\u0131z\u0131 Testi<\/td>\nMadde 201.12.1.101
Madde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nI:E Oran\u0131 Testi<\/td>\nMadde 201.12.1.101
Madde 201.12.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nO2 Konsantrasyon Testi<\/td>\nMadde 201.12.4.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nAlarm Test – T\u0131kan\u0131kl\u0131k<\/td>\nMadde 201.12.4.108<\/td>\n<\/tr>\n
Solunumla ilgili anestezi sistemleri: B\u00f6l\u00fcm-4 : Anestezik buhar verme Cihazlar\u0131-Vaporizat\u00f6rler<\/td>\nSolunumla ilgili anestezi sistemleri: B\u00f6l\u00fcm-4 : Anestezik buhar verme cihazlar\u0131 – Vaporizat\u00f6rler<\/td>\nTS EN ISO 8835-4<\/td>\n<\/tr>\n
\u00a0<\/td>\nGaz Konsantrasyonu \u00d6l\u00e7\u00fcm\u00fc<\/td>\nMadde 51.101<\/td>\n<\/tr>\n
T\u0131bbi Aspirasyon Donan\u0131m\u0131<\/td>\nT\u0131bbi aspirasyon donan\u0131m\u0131 – B\u00f6l\u00fcm 1: Elektrikle \u00e7al\u0131\u015fan aspirasyon donan\u0131m<\/td>\nTS EN ISO 10079-1
EN ISO 10079-1<\/td>\n<\/tr>\n
\u00a0<\/td>\nEmi\u015f Testi<\/td>\nMadde 9.1, 9.2, 9.3, 9.4, 9.5, 9.6 9.9, 9.10 (Aspirat\u00f6r tipine ba\u011fl\u0131 olarak)<\/td>\n<\/tr>\n
\u00a0<\/td>\nEmi\u015f G\u00f6sterge Do\u011frulu\u011fu Testi<\/td>\nMadde 9.7, 9.8<\/td>\n<\/tr>\n
\u00a0<\/td>\nSerbest Ak\u0131\u015f H\u0131z\u0131 Testi<\/td>\nMadde 9.1, 9.2, 9.3, 9.4, 9.5, 9.6 9.9, 9.10 (Aspirat\u00f6r tipine ba\u011fl\u0131 olarak)<\/td>\n<\/tr>\n
Fetal Monit\u00f6r<\/td>\nUltrasonikler – Problu, elde ta\u015f\u0131nan doppler fet\u00fcs kalp at\u0131m detekt\u00f6rleri -Performans \u00f6zellikleri ve \u00f6l\u00e7me ve raporlama y\u00f6ntemleri<\/td>\nTS EN 60601-2-27
EN 60601-2-27<\/td>\n<\/tr>\n
\u00a0<\/td>\nIntrauterin Bas\u0131n\u00e7 Testi<\/td>\nTS EN 60601-2-27<\/td>\n<\/tr>\n
\u00a0<\/td>\nNab\u0131z Testi<\/td>\nMadde 201.12.1.101.15<\/td>\n<\/tr>\n
\u00a0<\/td>\nNab\u0131z Alarm Test<\/td>\nMadde 201.12.1.101.7<\/td>\n<\/tr>\n
\u00a0<\/td>\nEKG Genlik Testi<\/td>\nMadde 201.12.1.101.16<\/td>\n<\/tr>\n
\u00a0<\/td>\nYaz\u0131c\u0131 Testi<\/td>\nMadde 208.6.6.2.103<\/td>\n<\/tr>\n
\u00a0<\/td>\nQRS Duyarl\u0131l\u0131k Testi<\/td>\nTS EN 60601-2-27<\/td>\n<\/tr>\n
Bebek K\u00fcv\u00f6zleri<\/td>\nElektrikli t\u0131bbi donan\u0131m – B\u00f6l\u00fcm 2-19: Bebek kuv\u00f6zlerinin temel g\u00fcvenli\u011fi ve gerekli performans\u0131 i\u00e7in belirli \u00f6zellikler<\/td>\nTS EN 60601-2-19
EN 60601-2-19
IEC 60601-2-19<\/td>\n<\/tr>\n
\u00a0<\/td>\nK\u00fcv\u00f6z i\u00e7i S\u0131cakl\u0131k ve Da\u011f\u0131l\u0131m\u0131 Testi<\/td>\nMadde 201.9.6.2.1.102<\/td>\n<\/tr>\n
\u00a0<\/td>\nK\u00fcv\u00f6z i\u00e7i Nem testi<\/td>\nMadde 201.12.1.109<\/td>\n<\/tr>\n
\u00a0<\/td>\nK\u00fcv\u00f6z i\u00e7i Hava Ak\u0131\u015f\u0131 Testi<\/td>\nMadde 201.12.1.111<\/td>\n<\/tr>\n
Tens Cihazlar\u0131<\/td>\nTens Cihazlar\u0131 i\u00e7in Performans Testleri<\/td>\nTSE EN 60601-2-10<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00c7\u0131k\u0131\u015f Genli\u011fi<\/td>\nTSE EN 60601-2-10<\/td>\n<\/tr>\n
\u00a0<\/td>\nTekrarlama Frekans\u0131<\/td>\nTSE EN 60601-2-10<\/td>\n<\/tr>\n
Solunum Fonksiyon Test Cihaz\u0131 (Spirometreler)<\/td>\nAnestezi ve solunum donan\u0131m\u0131 – \u0130nsanlarda zamana ba\u011fl\u0131 zorlu soluk verme hacimlerinin \u00f6l\u00e7\u00fclmesi i\u00e7in tasarlanan spirometreler<\/td>\nTSE EN ISO 26782<\/td>\n<\/tr>\n
\u00a0<\/td>\nFVC Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
\u00a0<\/td>\nFEV1 Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
\u00a0<\/td>\nFIVC Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
\u00a0<\/td>\nFEF25 Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
\u00a0<\/td>\nFEF50 Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
\u00a0<\/td>\nFEF75 Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
\u00a0<\/td>\nMMEF Performans\u0131 Testi<\/td>\nMadde 7<\/td>\n<\/tr>\n
BPAP Cihazlar\u0131<\/td>\nISO 80601-2-70:2015 -Medikal Elektriksel Donan\u0131m-Part 2-70: Uyku apnesi solunum tedavisi ekipman\u0131n\u0131n temel g\u00fcvenli\u011fi ve temel performans\u0131 i\u00e7in \u00f6zel gereksinimler. BPAP Cihaz\u0131 Performans\u0131 Testi.<\/td>\nISO 80601-2-70<\/td>\n<\/tr>\n
\u00a0<\/td>\nBas\u0131n\u00e7 Do\u011frulu\u011fu Performans Testi<\/td>\n201.12.4.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nBPAP Modunda Bas\u0131n\u00e7 Do\u011frulu\u011fu Testi<\/td>\n201.12.4.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nMaksimum Ak\u0131\u015f H\u0131z\u0131 Performans Testi<\/td>\n201.12.1.103<\/td>\n<\/tr>\n
CPAP Cihazlar\u0131<\/td>\nISO 80601-2-70:2015 – Medikal Elektriksel Donan\u0131m-Part 2-70: Uyku apnesi solunum tedavisi ekipman\u0131n\u0131n temel g\u00fcvenli\u011fi ve temel performans\u0131 i\u00e7in \u00f6zel gereksinimler. CPAP Cihazlar\u0131 Performans Testi.<\/td>\nISO 80601-2-70<\/td>\n<\/tr>\n
\u00a0<\/td>\nBas\u0131n\u00e7 Do\u011frulu\u011fu Performans Testi<\/td>\n201.12.4.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nCPAP Modunda Bas\u0131n\u00e7 Do\u011frulu\u011fu Testi<\/td>\n201.12.4.101<\/td>\n<\/tr>\n
\u00a0<\/td>\nMaksimum Ak\u0131\u015f H\u0131z\u0131 Performans\u0131 Testi<\/td>\n201.12.1.103<\/td>\n<\/tr>\n
Boncuklu Flowmetreler<\/td>\nT\u0131bbi gaz boru hatt\u0131 sistemlerinin u\u00e7 birimlerine ba\u011flant\u0131 i\u00e7in ak\u0131\u015f \u00f6l\u00e7me cihazlar\u0131
Flowmetre Cihazlar\u0131 Performans Testleri<\/td>\n		TS EN ISO 15002<\/td>\n<\/tr>\n
\u00a0<\/td>\nGaz Debisi H\u0131z\u0131 Performans Testi<\/td>\nMadde 5.4.6.3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u0130leti\u015fim bilgilerimiz i\u00e7in -> t\u0131klay\u0131n\u0131z<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

T\u00fcrkak Akreditasyon Kapsam\u0131 G\u00fcncellenmi\u015f T\u00fcrkak Akreditasyon Kapsam\u0131 a\u015fa\u011f\u0131daki gibidir. T\u00fcrkak sitesi linki i\u00e7in -> t\u0131klay\u0131n\u0131z. Medibim;\u00a0 medikal cihazlar\u0131n performans testleri,<\/p>\n","protected":false},"author":18,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"colormag_page_container_layout":"default_layout","colormag_page_sidebar_layout":"default_layout","footnotes":""},"categories":[972,51],"tags":[948,1200,1201,1204,1033],"class_list":["post-3054","post","type-post","status-publish","format-standard","hentry","category-kurumsal","category-medibim-haberler","tag-iso-17025","tag-medibim-akreditasyon","tag-medibim-turkak","tag-test-deney-laboratuvari","tag-tibbi-cihaz-kalibrasyon"],"yoast_head":"\nT\u00fcrkak Akreditasyon Kapsam\u0131 - Medibim Biyomedikal Metroloji ve Kalibrasyon<\/title>\n<meta name=\"description\" content=\"Kurumsal - T\u00fcrkak Akreditasyon Kapsam\u0131 - Medibim Biyomedikal Metroloji ve Kalibrasyon\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.medibim.com.tr\/TR\/medibim-haberler\/turkak-akreditasyon-kapsami\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"T\u00fcrkak Akreditasyon Kapsam\u0131 - 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