{"id":207,"date":"2013-09-26T09:08:04","date_gmt":"2013-09-26T07:08:04","guid":{"rendered":"https:\/\/medibim.com.tr\/TR\/2013\/09\/26\/iso-14644-clean-room-temiz-oda\/"},"modified":"2025-04-18T11:06:27","modified_gmt":"2025-04-18T08:06:27","slug":"iso-14644-clean-room-temiz-oda","status":"publish","type":"post","link":"https:\/\/www.medibim.com.tr\/TR\/temiz-oda-validasyon-ekipmanlari\/iso-14644-clean-room-temiz-oda\/","title":{"rendered":"ISO 14644 Temiz Oda Clean Room Standard\u0131"},"content":{"rendered":"<p><span style=\"font-size: 12pt;\">ISO 14644 Temiz Oda Clean Room Standard\u0131, <\/span>Temiz odalar ve bu odalarla birlikte kontrol edilen ortamlar\u0131 belirlemektedir.<\/p>\n<p>Standard\u0131n temelini US Federal Standard 209E olu\u015fturmaktad\u0131r. 1999 y\u0131l\u0131nda standard\u0131n ilk b\u00f6l\u00fcm\u00fc olan \u201cb\u00f6l\u00fcm\u00fc hava temizli\u011finin kontrol edilmesi\u201d d\u00f6k\u00fcman\u0131 yay\u0131nlanm\u0131\u015ft\u0131r. Bu standard, CEN taraf\u0131ndan kabul edilen EN ISO 14644-1 (1999) standard\u0131 esas al\u0131narak, TSE Sa\u011fl\u0131k Haz\u0131rl\u0131k Grubunca TS 11605 (1995)\u2019in revizyonu olarak haz\u0131rlanm\u0131\u015f ve TSE Teknik Kurulu\u2019nun 10 May\u0131s 2001 tarihli toplant\u0131s\u0131nda T\u00fcrk Standard\u0131 olarak kabul edilerek yay\u0131m\u0131na karar verilmi\u015ftir.<\/p>\n<h1><span style=\"font-size: 14pt;\">ISO 14644 Temiz Oda Clean Room Standard\u0131<\/span><\/h1>\n<h2><span style=\"font-size: 12pt;\">B\u00f6l\u00fcmleri<\/span><\/h2>\n<p>Toplam 9 b\u00f6l\u00fcmden olu\u015fmaktad\u0131r;<\/p>\n<p><strong><br \/>ISO 14644-2:<\/strong> B\u00f6l\u00fcm 2: ISO 14644-1 &#8216;e s\u00fcrekli uygunlu\u011funun s\u0131nanmas\u0131 i\u00e7in deney ve izleme \u015fartlar\u0131\u00a0(Specifications for testing and monitoring to prove continued compliance with ISO 14644-1)<strong>ISO 14644-1:<\/strong> B\u00f6l\u00fcm 1: Hava Temizli\u011finin S\u0131n\u0131fland\u0131r\u0131lmas\u0131 (Classification of air cleanliness)<\/p>\n<p><strong>ISO 14644-3:<\/strong> B\u00f6l\u00fcm 3-Deney Metotlar\u0131 (Test Methods)<\/p>\n<p><strong>ISO 14644-4:<\/strong> B\u00f6l\u00fcm 4: Tasar\u0131m, in\u015faat ve ilk \u00e7al\u0131\u015ft\u0131rma (Design, Construction, and Start-up)<\/p>\n<p><strong>ISO 14644-5:<\/strong> B\u00f6l\u00fcm 5: \u0130\u015fletme (Operations)<\/p>\n<p><strong>ISO 14644-6:<\/strong> B\u00f6l\u00fcm 6: Terimler ve tarifler \u00a0(Vocabulary)<\/p>\n<p><strong>ISO 14644-7:<\/strong> B\u00f6l\u00fcm 7: Ay\u0131r\u0131c\u0131 cihazlar (temiz hava davlumbazlar\u0131, eldivenli kutular, yal\u0131t\u0131c\u0131lar ve mini ortamlar)\u00a0 [Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)]<\/p>\n<p><strong>ISO 14644-8:<\/strong> B\u00f6l\u00fcm 8: Hava kaynakl\u0131 molek\u00fcler kirlenmenin s\u0131n\u0131fland\u0131r\u0131lmas\u0131 (Classification of airborne molecular contamination)<\/p>\n<p><strong>ISO 14644-9:<\/strong> B\u00f6l\u00fcm 9: Y\u00fczey partik\u00fcl temizli\u011finin s\u0131n\u0131fland\u0131r\u0131lmas\u0131 ( Classification of surface particle cleanliness )<\/p>\n<p>Bu standartlar b\u00f6l\u00fcmlerinden 1,2,3,4,5,7 ve 8 <a href=\"http:\/\/www.tse.org.tr\/\">www.tse.org.tr<\/a> adresinden temin edilebilir. 6. B\u00f6l\u00fcm hen\u00fcz TSE i\u015f program\u0131ndad\u0131r. 9. B\u00f6l\u00fcm ise hen\u00fcz ISO (International Organization for Standardization, <a href=\"http:\/\/www.iso.org\/\">www.iso.org<\/a> ) komisyon tasla\u011f\u0131 a\u015famas\u0131ndad\u0131r.<\/p>\n<h2 align=\"left\"><span style=\"font-size: 12pt;\">TS EN ISO 14644\u20131 Konusu ve Kapsam\u0131 Nedir?<\/span><\/h2>\n<p>Temiz odalar ve bu odalarla birlikte kontrol edilen ortamlar\u0131 (Cleanrooms and associated controlled environments) konu alan bu standard\u0131n ilk b\u00f6l\u00fcm\u00fc hava temizli\u011finin kontrol edilmesi (Part 1: Classification of air cleanliness) olarak belirlenmi\u015ftir.\u00a0<strong>\u00a0<\/strong><\/p>\n<p align=\"left\">TS 11605 EN ISO 14644-1 nas\u0131l temin edilebilir?<\/p>\n<p>TSE taraf\u0131ndan terc\u00fcmesi yap\u0131lm\u0131\u015f ve T\u00fcrkiye \u015fartlar\u0131 i\u00e7in standart halde yay\u0131nlanm\u0131\u015ft\u0131r.<\/p>\n<p><a href=\"http:\/\/www.tse.org.tr\/\">www.tse.org.tr<\/a> web adresinden temin edilebilir.<strong>\u00a0<\/strong><\/p>\n<p align=\"left\">TS EN ISO 14644-1 Ana ba\u015fl\u0131k ve ekleri nelerdir?<\/p>\n<p>May\u0131s 2001\u2019de y\u00fcr\u00fcrl\u00fc\u011fe giren standart toplam 4 ba\u015fl\u0131k ve bilgi i\u00e7in verilen 6 ekten\u00a0 (Ek A, B, C, D, E, ve F)\u00a0 olu\u015fur ve 26 sayfad\u0131r.<\/p>\n<p>Giri\u015f<\/p>\n<p>1.\u00a0\u00a0\u00a0\u00a0 Kapsam<\/p>\n<p>2.\u00a0\u00a0\u00a0\u00a0 Tarifler<\/p>\n<p>3.\u00a0\u00a0\u00a0\u00a0 S\u0131n\u0131fland\u0131rma<\/p>\n<p>4.\u00a0\u00a0\u00a0\u00a0 Uygunlu\u011fun g\u00f6sterilmesi<\/p>\n<p>Ek A (Bilgi i\u00e7in) \u00c7izelge 1\u2019deki s\u0131n\u0131flar\u0131n grafikle g\u00f6sterimi<\/p>\n<p>Ek B Ayr\u0131k partik\u00fcl say\u0131c\u0131, \u0131\u015f\u0131kl\u0131 da\u011f\u0131tma aleti kullan\u0131larak partik\u00fclden temizlik tayini<\/p>\n<p>EK C Partik\u00fcl konsantrasyonu verisinin istatistiksel de\u011ferlendirilmesi<\/p>\n<p>Ek D (Bilgi i\u00e7in) S\u0131n\u0131fland\u0131rma amac\u0131yla yap\u0131lm\u0131\u015f hesaplama \u00f6rnekleri<\/p>\n<p>Ek E (Bilgi i\u00e7in) S\u0131n\u0131fland\u0131rmaya uygulanabilen boyut aral\u0131\u011f\u0131 d\u0131\u015f\u0131nda kalan partik\u00fcllerin say\u0131m\u0131 ve boyutlar\u0131n\u0131n belirlenmesi i\u00e7in de\u011ferlendirmeler<\/p>\n<p>Ek F (Bilgi i\u00e7in) Ard\u0131\u015f\u0131k numune alma i\u015flemi<\/p>\n<h2 align=\"left\"><span style=\"font-size: 12pt;\">G\u0130R\u0130\u015e<\/span><\/h2>\n<p><span style=\"font-size: 12pt;\">ISO 14644 Temiz Oda Clean Room Standard\u0131 <\/span>giri\u015f k\u0131sm\u0131nda hava ile ta\u015f\u0131nan kontaminasyon ve bu kontaminasyon i\u00e7in belirlenen s\u0131n\u0131r de\u011ferlerin standartta a\u00e7\u0131k\u00e7a ortaya konuldu\u011fu belirtilmektedir. Yine Bu standartta; s\u0131n\u0131fland\u0131rma ama\u00e7lar\u0131 i\u00e7in; partik\u00fcl konsantrasyon s\u0131n\u0131rlar\u0131n\u0131 belirlemek \u00fczere, s\u00f6z konusu partik\u00fcller i\u00e7in tasarlanm\u0131\u015f bir boyut aral\u0131\u011f\u0131 da verilmektedir. Bu standart, ayn\u0131 zamanda; s\u0131n\u0131fland\u0131rmada tasarlanm\u0131\u015f partik\u00fcl boyut aral\u0131\u011f\u0131ndaki de\u011ferlerden daha b\u00fcy\u00fck veya k\u00fc\u00e7\u00fck partik\u00fcllerin hava ile ta\u015f\u0131nan konsantrasyonuna dayal\u0131 temizlik d\u00fczeylerinin belirlenmesi ve tasarlanmas\u0131 i\u00e7in standart protokolleri de verdi\u011finden bahsedilmektedir.<\/p>\n<h2 align=\"left\"><span style=\"font-size: 12pt;\">1.\u00a0\u00a0\u00a0\u00a0\u00a0 KAPSAM<\/span><\/h2>\n<p>Kapsam k\u0131sm\u0131nda dikkat \u00e7eken en \u00f6nemli husus standard\u0131n 0,1 \u03bcm ila 5 \u03bcm aras\u0131ndaki partik\u00fclleri esas ald\u0131\u011f\u0131, bunun alt\u0131nda ve \u00fczerindeki partik\u00fcllerin U (\u00c7ok k\u00fc\u00e7\u00fck partik\u00fcller) ve M (makro partik\u00fcller) tan\u0131mlay\u0131c\u0131lar\u0131yla miktarlar\u0131n\u0131n belirlenmesinde kullan\u0131labildi\u011fini belirtmektedir. Ayr\u0131ca standard\u0131n hava ile ta\u015f\u0131nan partik\u00fcllerin fiziksel, kimyasal, radyolojik veya ge\u00e7irgen yap\u0131lar\u0131n\u0131 belirtmek i\u00e7in kullan\u0131lamayaca\u011f\u0131 bu ba\u015fl\u0131kta a\u00e7\u0131k\u00e7a belirtilmi\u015ftir.<\/p>\n<h2 align=\"left\"><span style=\"font-size: 12pt;\">2.\u00a0\u00a0\u00a0\u00a0\u00a0 TAR\u0130FLER<\/span><\/h2>\n<p>Standard\u0131n ama\u00e7lar\u0131n\u0131 belirleyen tarifler bu ba\u015fl\u0131k alt\u0131nda s\u0131ralanm\u0131\u015ft\u0131r. Tarifler hakk\u0131nda k\u0131sa ve \u00f6z bilgiler de a\u015fa\u011f\u0131da sunulmu\u015ftur.<\/p>\n<h3 align=\"left\"><span style=\"font-size: 12pt;\">2.1\u00a0\u00a0 Genel<\/span><\/h3>\n<p>2.1.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Temiz oda<strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 :<\/strong> Partik\u00fcllerin giri\u015fi, olu\u015fumu ve al\u0131konulmas\u0131 en aza indirilen, atmosferik \u015fartlar bak\u0131m\u0131ndan kontroll\u00fc (havaland\u0131rma, s\u0131cakl\u0131k, ba\u011f\u0131l nem ve bas\u0131n\u00e7 gibi) kapal\u0131 hacimler.<\/p>\n<p>2.1.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Temiz b\u00f6lge\u00a0\u00a0\u00a0 : Temiz oda ile ayn\u0131 \u015fartlar\u0131 ta\u015f\u0131yan, temiz odan\u0131n bir b\u00f6l\u00fcm\u00fc olabildi\u011fi gibi a\u00e7\u0131k yada kapal\u0131 da olabilen b\u00f6lge.<\/p>\n<p>2.1.3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Tesisat \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : Temiz oda beraberinde, temiz oda ko\u015fullar\u0131n\u0131n tesisine yard\u0131mc\u0131 olan sistem ve ekipmanlar b\u00fct\u00fcn\u00fc<\/p>\n<p>2.1.4\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 S\u0131n\u0131fland\u0131rma\u00a0 : De\u011ferlendirmeye tabi tutulan ilgili partik\u00fcl \u00e7aplar\u0131 i\u00e7in m\u00fcsaade edilen partik\u00fcl s\u0131n\u0131r konsantrasyonlar\u0131na (1 m3 havadaki partik\u00fcl say\u0131s\u0131) ba\u011fl\u0131 olarak yap\u0131lan s\u0131n\u0131r belirleme ve tayin i\u015flemi<\/p>\n<p align=\"left\">2.2\u00a0\u00a0\u00a0 Hava ile ta\u015f\u0131nan partik\u00fcller<\/p>\n<p>2.2.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Partik\u00fcl\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0 : Bu standart i\u00e7in 0,1\u03bcm\u2019den 5\u03bcm \u00e7apa kadar olan kat\u0131 ve\/veya s\u0131v\u0131 cisimlerdir.<\/p>\n<p>2.2.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Partik\u00fcl boyutlar\u0131\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0 : \u00c7ap\u0131 belirli bir referans partik\u00fcl ile e\u015fde\u011fer tepkiler veren k\u00fcrenin \u00e7ap\u0131.<\/p>\n<p>2.2.3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Partik\u00fcl konsantrasyonu\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0 : Birim hacim havada, ayr\u0131 haldeki partik\u00fcl say\u0131s\u0131.<\/p>\n<p>2.2.4\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Partik\u00fcl boyutlar\u0131n\u0131n da\u011f\u0131l\u0131m\u0131\u00a0\u00a0\u00a0\u00a0 : Partik\u00fcl boyutunun bir fonksiyonu olan partik\u00fcl konsantrasyonunun k\u00fcm\u00fclatif da\u011f\u0131l\u0131m\u0131d\u0131r.<\/p>\n<p>2.2.5\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00c7ok k\u00fc\u00e7\u00fck partik\u00fcl\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : E\u015f de\u011fer \u00e7ap\u0131) 0,1\u03bcm\u2019den daha k\u00fc\u00e7\u00fck olan partik\u00fcl.<\/p>\n<p>2.2.6\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Makro partik\u00fcl\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : (E\u015f de\u011fer \u00e7ap\u0131) 5\u03bcm\u2019den daha b\u00fcy\u00fck olan partik\u00fcl.<\/p>\n<p>2.2.7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Fiber\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : G\u00f6r\u00fcn\u00fcm oran\u0131 (uzunluk\/geni\u015flik) 10 veya daha b\u00fcy\u00fck olan par\u00e7a<\/p>\n<p align=\"left\">2.3\u00a0\u00a0\u00a0 Tan\u0131mlay\u0131c\u0131lar<\/p>\n<p>2.3.1U-Tan\u0131mlay\u0131c\u0131s\u0131\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : Mikro partik\u00fcller<\/p>\n<p>2.3.2M-Tan\u0131mlay\u0131c\u0131s\u0131\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : Makro partik\u00fcller<\/p>\n<p align=\"left\">2.4\u00a0\u00a0\u00a0 Odan\u0131n kullan\u0131m durumlar\u0131<\/p>\n<p>2.4.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Yap\u0131m\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : (As Building) Tesisin tam anlam\u0131yla haz\u0131r oldu\u011fu ancak donan\u0131m ve personelin olmad\u0131\u011f\u0131 durumdur.<\/p>\n<p>2.4.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Duraklama\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : (At rest) Tesisin donan\u0131m ile birlikte haz\u0131r oldu\u011fu ancak personelin olmad\u0131\u011f\u0131 durumdur.<\/p>\n<p>2.4.3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u0130\u015fletim\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : (Operational) Tesisin donan\u0131m ve personel ile birlikte \u00e7al\u0131\u015ft\u0131r\u0131ld\u0131\u011f\u0131 durumdur.<\/p>\n<p align=\"left\">\u00a02.5\u00a0\u00a0\u00a0 Taraflar<\/p>\n<p>2.5.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 M\u00fc\u015fteri : Bir temiz oda veya temiz b\u00f6lgenin \u00f6zelliklerinin belirlenmesinden sorumlu organizasyon veya kurulu\u015f.<\/p>\n<p>2.5.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Tedarik\u00e7i\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : Bir temiz oda veya temiz b\u00f6lgenin belirlenmi\u015f \u00f6zelliklerinin kar\u015f\u0131lanmas\u0131 ile g\u00f6revli organizasyon.<\/p>\n<h2><span style=\"font-size: 12pt;\">3.\u00a0\u00a0\u00a0\u00a0\u00a0 SINIFLANDIRMA<\/span><\/h2>\n<p align=\"left\">3.1\u00a0\u00a0\u00a0 Odan\u0131n Kullan\u0131m Durumu \/ Durumlar\u0131<\/p>\n<p>Bir temiz oda ya da temiz b\u00f6lgenin temiz olup olmad\u0131\u011f\u0131n\u0131n belirlenmesi odan\u0131n kullan\u0131m durumuna ba\u011fl\u0131d\u0131r. Bu durumlar standard\u0131n 2,4 maddesinde belirten yap\u0131m, duraklama ve i\u015fletim durumlar\u0131nda biri veya daha fazlas\u0131 ile tan\u0131mlanabilir. Burada \u00f6zellikle dikkat edilmesi gereken husus \u201cYap\u0131m\u201d durumunun, yeni tamamlanm\u0131\u015f veya yeni olu\u015fturulmu\u015f temiz odalar veya temiz b\u00f6lgeler i\u00e7in uygulanabilir oldu\u011fu ko\u015fuludur. \u201cYap\u0131m\u201d durumunda deneme tamamland\u0131\u011f\u0131nda \u201cduraklama\u201d veya \u201ci\u015fletim\u201d durumunda veya her iki durumda uygunluk i\u00e7in ba\u015fka denemeler yap\u0131lmal\u0131d\u0131r.<\/p>\n<p>3.2\u00a0 S\u0131n\u0131fland\u0131rma numaras\u0131\u00a0Hava ile ta\u015f\u0131nan partik\u00fcllerin temizlik s\u0131n\u0131fland\u0131rmas\u0131 N numaras\u0131 ile tespit edilmektedir. Her bir partik\u00fcl\u00fcn boyutu (D) i\u00e7in m\u00fcsaade edilen en y\u00fcksek partik\u00fcl konsantrasyonu (Cn) standartta \u015fu \u015fekilde verilmektedir;<\/p>\n<p align=\"center\"><strong>Cn = 10<sup>N<\/sup> x (0.1\/D)<sup>2,08<\/sup><\/strong><\/p>\n<p>Bu e\u015fitlikle ilgili olarak baz\u0131 hususlar standartta \u015fu \u015fekilde a\u00e7\u0131klanm\u0131\u015ft\u0131r;<\/p>\n<ul>\n<li>Cn; De\u011ferlendirilen partik\u00fcl boyutuna e\u015fit veya daha b\u00fcy\u00fck hava ile ta\u015f\u0131nan partik\u00fcllerin m\u00fcsaade edilen en y\u00fcksek konsantrasyonudur (partik\u00fcl (m3 hava))<\/li>\n<li>N; 9\u2019u a\u015fmayan ISO s\u0131n\u0131fland\u0131rma say\u0131s\u0131d\u0131r. Orta de\u011ferdeki ISO s\u0131n\u0131fland\u0131rma say\u0131lar\u0131 m\u00fcsaade edilen art\u0131\u015f olan 0,1 aral\u0131klar\u0131 ile belirlenebilir.<\/li>\n<li>D De\u011ferlendirmeye al\u0131nan partik\u00fcl boyutudur, mikrometre cinsindendir.<\/li>\n<li>0,1 Sabit say\u0131d\u0131r boyutlar mikrometre cinsindendir.<\/li>\n<\/ul>\n<p>3.3\u00a0 Tasar\u0131m<strong>\u00a0<\/strong>Temiz oda ve temiz b\u00f6lgeler i\u00e7in temizlik tasar\u0131m\u0131 3 ana maddeyi i\u00e7ermelidir;<\/p>\n<p>a)\u00a0\u00a0\u00a0\u00a0 S\u0131n\u0131fland\u0131rma numaras\u0131 (ISO S\u0131n\u0131f 3, ISO S\u0131n\u0131f 5 gibi)<\/p>\n<p>b)\u00a0\u00a0\u00a0 Odan\u0131n kullan\u0131m durumu (Yap\u0131m, Duraklama, \u0130\u015fletim)<\/p>\n<p>c)\u00a0\u00a0\u00a0\u00a0 De\u011ferlendirmeye al\u0131nan partik\u00fcl boyutlar\u0131 ve hesaplanan konsantrasyon Tasar\u0131m \u00f6rne\u011fi olarak \u201cISO s\u0131n\u0131f 4; i\u015fletim durumu; de\u011ferlendirmeye al\u0131nan boyutlar; 0,2 \u03bcm (2370 partik\u00fcl\/ m<sup>3<\/sup>), 1 \u03bcm (83 partik\u00fcl\/m<sup>3<\/sup>)\u201d olarak verilebilir.\u00a0Konsantrasyonlar\u0131 belirlemek a\u00e7\u0131s\u0131ndan dikkate al\u0131nacak partik\u00fcl \u00e7aplar\u0131na m\u00fc\u015fteri ve tedarik\u00e7i birlikte karar vermelidirler. Belirlenecek partik\u00fcl \u00e7aplar\u0131 i\u00e7in s\u0131n\u0131rlay\u0131c\u0131 olan tek \u015fey belirlenen ilk partik\u00fcl (D<sub>1<\/sub>) ile ikinci partik\u00fcl (D<sub>2<\/sub>) \u00e7aplar\u0131 aras\u0131nda en az 1,5 kat olmal\u0131d\u0131r.<\/p>\n<p align=\"center\">\u00a0<strong>D<sub>2 <\/sub>\u22651,5* D<sub>1<\/sub><\/strong><\/p>\n<h1>\u00a0<\/h1>\n<h2><span style=\"font-size: 12pt;\">4\u00a0\u00a0\u00a0\u00a0\u00a0 UYGUNLU\u011eUN G\u00d6STER\u0130LMES\u0130<\/span><\/h2>\n<p>4.1\u00a0 M\u00fc\u015fteri<strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 : <\/strong>Gerekli dok\u00fcmanlar\u0131n temini, \u00f6l\u00e7\u00fcm ve hesaplama sonucunda tespit edilen ISO s\u0131n\u0131f\u0131n\u0131n uygun olup olmad\u0131\u011f\u0131n\u0131 do\u011frulamak.<strong> \u00a0<\/strong><\/p>\n<p>4.2\u00a0 Deneyler\u00a0\u00a0<strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 :\u00a0 <\/strong>Standard\u0131n Ek B maddesinde (Ayr\u0131k partik\u00fcl say\u0131c\u0131, \u0131\u015f\u0131kl\u0131 da\u011f\u0131tma aleti kullan\u0131larak partik\u00fclden temizlik tayini) uygunlu\u011fun ortaya konmas\u0131 i\u00e7in referans deney metodu tan\u0131mlanm\u0131\u015ft\u0131r. Herhangi bir kar\u015f\u0131la\u015ft\u0131r\u0131labilir alternatif metot \u00fczerinde uzla\u015f\u0131lmam\u0131\u015f ise bu referans metodun uygulanmas\u0131 uygundur. Burada \u00f6nemli olan kullan\u0131lacak referans cihaz\u0131n kalibrasyonunun yap\u0131lm\u0131\u015f ve kalibrasyon tarihinin g\u00fcncel olmas\u0131d\u0131r.<\/p>\n<p>4.3\u00a0 Hava kaynakl\u0131 partik\u00fcl konsantrasyon s\u0131n\u0131rlar\u0131 : \u00a0\u00a0<strong>\u00a0\u00a0\u00a0\u00a0\u00a0 <\/strong>Madde 4,2\u2019de belirtilen deneyin tamamlanmas\u0131n\u0131n ard\u0131ndanortalama partik\u00fcl konsantrasyonlar\u0131 ve % 95 g\u00fcvenlik \u00fcst s\u0131n\u0131r\u0131 standard\u0131n Ek C (Partik\u00fcl konsantrasyonu verisinin istatistiksel de\u011ferlendirilmesi) maddesinde belirtildi\u011fi \u015fekilde hesaplanmal\u0131d\u0131r.<\/p>\n<p>4.4\u00a0 Deney Raporu :<strong>\u00a0 <\/strong>Her bir temiz odada \/ temiz b\u00f6lgede y\u00fcr\u00fct\u00fclen \u00e7al\u0131\u015fma, kapsaml\u0131 bir rapor halinde haz\u0131rlanarak kay\u0131t alt\u0131na al\u0131nmal\u0131d\u0131r.<strong>\u00a0<\/strong>Deney raporu i\u00e7eri\u011fi ile ilgili bilgiler standartta \u015fu \u015fekilde belirtilmi\u015ftir;<\/p>\n<p>a)\u00a0\u00a0\u00a0\u00a0 Deneyi yapan\u0131n ismi ve adresi, deney tarihi<\/p>\n<p>b)\u00a0\u00a0\u00a0 Standard\u0131n numaras\u0131 ve bas\u0131ld\u0131\u011f\u0131 y\u0131l (EN ISO 14644:2001)<\/p>\n<p>c)\u00a0\u00a0\u00a0\u00a0 Denenen temiz oda veya temiz b\u00f6lgenin fiziksel konumuna dair a\u00e7\u0131k bir tan\u0131mlama (gerekli ise; kom\u015fu alanlara atf\u0131 da i\u00e7ererek) ve b\u00fct\u00fcn numune alma yerlerinin koordinatlar\u0131 i\u00e7in \u00f6zel tasar\u0131mlar<\/p>\n<p>d)\u00a0\u00a0\u00a0 Temiz oda veya temiz b\u00f6lge i\u00e7in ISO s\u0131n\u0131fland\u0131rmas\u0131n\u0131 da i\u00e7eren belirlenmi\u015f tasar\u0131m kriteri ilgili kullan\u0131m durumu\/durumlar\u0131 ve de\u011ferlendirmeye al\u0131nan partik\u00fcl boyutu\/boyutlar\u0131<\/p>\n<p>e)\u00a0\u00a0\u00a0\u00a0 Deneyle ilgili t\u00fcm \u00f6zel \u015fartlarla birlikte kullan\u0131lan deney metodunun detaylar\u0131 veya deney metodundan sapmalar (departure) ve deney aletinin tan\u0131mlanmas\u0131 ve ge\u00e7erli kalibrasyon sertifikas\u0131<\/p>\n<p>f)\u00a0\u00a0\u00a0\u00a0 B\u00fct\u00fcn numune alma yerlerinin koordinatlar\u0131 i\u00e7in partik\u00fcl konsantrasyon verisini kapsayan deney sonu\u00e7lar\u0131Ayr\u0131ca, \u00c7ok k\u00fc\u00e7\u00fck veya makro partik\u00fcllerin konsantrasyonlar\u0131 Ek E\u2019de (S\u0131n\u0131fland\u0131rmaya uygulanabilen boyut aral\u0131\u011f\u0131 d\u0131\u015f\u0131nda kalan partik\u00fcllerin say\u0131m\u0131 ve boyutlar\u0131n\u0131n belirlenmesi i\u00e7in de\u011ferlendirmeler) belirtildi\u011fi gibi hesaplanm\u0131\u015f ise; buna ili\u015fkin bilgi deney raporu kapsam\u0131nda bulunmal\u0131d\u0131r.<strong>\u00a0<\/strong><\/p>\n<h2><span style=\"font-size: 12pt;\">EN ISO 14644-1 Taraf\u0131ndan belirlenen Temiz Oda S\u0131n\u0131flar\u0131 ve Konsantrasyon d\u00fczeyleri nelerdir?<\/span><\/h2>\n<p>EN ISO 14644-1 taraf\u0131ndan toplam 9 s\u0131n\u0131f belirlenmi\u015ftir. Bu s\u0131n\u0131flar ve partik\u00fcl \u00e7aplar\u0131na ba\u011fl\u0131 olarak kabul edilebilir konsantrasyon d\u00fczeyleri (Standartta yer alan Madde 3.2\u2019deki e\u015fitlik (1)\u2019e g\u00f6re hesaplanm\u0131\u015flard\u0131r. ) standartta \u201c\u00c7izelge 1\u201d olarak yer alan \u015fu tablodur;<\/p>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\" rowspan=\"2\"><strong>ISO S\u0131n\u0131fland\u0131rma Say\u0131s\u0131 (N)<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\" colspan=\"6\"><strong>De\u011ferlendirmeye al\u0131nan boyutlardan daha b\u00fcy\u00fck ve e\u015fit partik\u00fcller i\u00e7in eny\u00fcksek konsantrasyon d\u00fczeyleri (partik\u00fcl\/m<sup>3 <\/sup>hava)<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>0,1 \u03bcm<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\"><strong>0,2 \u03bcm<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\"><strong>0,3 \u03bcm<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\"><strong>0,5 \u03bcm<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\"><strong>1 \u03bcm<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\"><strong>5 \u03bcm<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 1<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">10<\/td>\n<td style=\"border: 1px solid #28d7c2;\">2<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 2<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">100<\/td>\n<td style=\"border: 1px solid #28d7c2;\">24<\/td>\n<td style=\"border: 1px solid #28d7c2;\">10<\/td>\n<td style=\"border: 1px solid #28d7c2;\">4<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 3<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">1000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">237<\/td>\n<td style=\"border: 1px solid #28d7c2;\">102<\/td>\n<td style=\"border: 1px solid #28d7c2;\">35<\/td>\n<td style=\"border: 1px solid #28d7c2;\">8<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 4<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">10000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">2370<\/td>\n<td style=\"border: 1px solid #28d7c2;\">1020<\/td>\n<td style=\"border: 1px solid #28d7c2;\">352<\/td>\n<td style=\"border: 1px solid #28d7c2;\">83<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 5<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">100000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">23700<\/td>\n<td style=\"border: 1px solid #28d7c2;\">10200<\/td>\n<td style=\"border: 1px solid #28d7c2;\">3520<\/td>\n<td style=\"border: 1px solid #28d7c2;\">832<\/td>\n<td style=\"border: 1px solid #28d7c2;\">29<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 6<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">1000000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">237000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">102000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">35200<\/td>\n<td style=\"border: 1px solid #28d7c2;\">8320<\/td>\n<td style=\"border: 1px solid #28d7c2;\">239<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 7<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">352000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">83200<\/td>\n<td style=\"border: 1px solid #28d7c2;\">2390<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 8<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">3520000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">832000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">23900<\/td>\n<\/tr>\n<tr>\n<td style=\"border: 1px solid #28d7c2;\"><strong>ISO S\u0131n\u0131f 9<\/strong><\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">\u00a0<\/td>\n<td style=\"border: 1px solid #28d7c2;\">35200000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">8320000<\/td>\n<td style=\"border: 1px solid #28d7c2;\">239000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>EN ISO 14644-1 standard\u0131 Ek-B \u2018de belirtilen \u201c\u0131\u015f\u0131k da\u011f\u0131tma aleti kullan\u0131larak partik\u00fclden temizlik tayini\u201d ile ifade edilen cihazlar nedir?<\/strong><strong>\u00a0<\/strong><\/p>\n<p>Sa\u00e7\u0131lma prensibini kullanan, dahili bir lazer kayna\u011f\u0131 ve belirli bir debide s\u00fcrekli emi\u015f yapabilen pompas\u0131 olan partik\u00fcl say\u0131m cihazlar\u0131d\u0131r. Farkl\u0131 amaca hizmet edecek bi\u00e7imde, farkl\u0131 debi (1 CFM, 20 CFM, 2.83Lt\/dk, 50Lt\/dk., 100lt\/dk.), farkl\u0131\u00a0 kanal say\u0131s\u0131 (3, 6 ve 8 kanal gibi) ve farkl\u0131 partik\u00fcl \u00e7aplar\u0131nda s\u0131n\u0131fland\u0131rma yapabilen cihazlard\u0131r. Bu cihazlar\u0131n geli\u015fmi\u015f versiyonlar\u0131 dahili yaz\u0131l\u0131mlar\u0131 ile ISO 14644-1\u2019e uygun hesaplama ve raporlamalar\u0131 otomatik olarak yapabilmektedir. Bunun yan\u0131nda FED STD (US Federal Standard 209E*) ve EU GMP (Good Manifacturing Paractises)\u00a0 standartlar\u0131na uygun raporlama yapabilenleri de mevcuttur. * US Federal Standard 209E her ne kadar 29 Kas\u0131m 2001 tarihinde GSA (U.S. General Services Administration) taraf\u0131ndan y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lm\u0131\u015f olsa da pek \u00e7ok end\u00fcstri taraf\u0131ndan halen kabul g\u00f6rmekte ve aranmaktad\u0131r.<\/p>\n<p>\u00a0<\/p>\n<p>Temiz Oda validasyon ekipman ve \u00fcr\u00fcnlerimiz i\u00e7in -&gt; <a href=\"https:\/\/www.medibim.com.tr\/TR\/sugold\/\">t\u0131klay\u0131n\u0131z.<\/a><\/p>\n<hr \/>\n\n\n\n","protected":false},"excerpt":{"rendered":"<p>ISO 14644 Temiz Oda Clean Room Standard\u0131, Temiz odalar ve bu odalarla birlikte kontrol edilen ortamlar\u0131 belirlemektedir. Standard\u0131n temelini US<\/p>\n","protected":false},"author":18,"featured_media":2017,"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":[38],"tags":[303,112,304,102],"class_list":["post-207","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-temiz-oda-validasyon-ekipmanlari","tag-clean-room-standard","tag-iso-14644","tag-temiz-oda-standart","tag-temiz-oda-validasyon"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 14644 Temiz Oda Clean Room Standard\u0131 - Medibim Biyomedikal Metroloji ve Kalibrasyon<\/title>\n<meta name=\"description\" content=\"Temiz Oda Validasyon Ekipmanlar\u0131 - ISO 14644 Temiz Oda Clean Room Standard\u0131 - Medibim Biyomedikal Metroloji ve 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