標準編號:	GB/T 16293-2010
中文名稱:	醫藥工業潔凈室(區)浮游菌的測試方法
英文名稱:	Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
中標分類:	C30    醫療器械綜合
行業分類:	GB    國家標準
ICS分類:	13.040.30 13.040.30    工作場所空氣 13.040.30
發布機構:	國家質量監督檢驗檢疫總局 國家標準化管理委員會
發布日期:	2010-9-2
實施日期:	2011-2-1
標準狀態:	valid
替代舊標準:	GB/T 16293-1996 醫藥工業潔凈室(區)浮游菌的測試方法
翻譯語言:	英文
文件格式:	PDF
中文字符數:	12000 字
翻譯價格(元):	290.0
交付時間:	付款后 1 個工作日

1 Scope This standard specifies the test condition and method for airborne microbe in clean room (zone) of the pharmaceutical industry. This standard is applicable to the verification for test and environment of airborne microbe in clean room (zone), sterile room or localized air purification zone (including clean bench) of the pharmaceutical industry. 2 Normative References The following normative documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest editions apply. GB/T 16292-2010 Test Method for Airborne Particles in Clean Room (Zone) of the Pharmaceutical Industry JGJ 71-1990 Specification for Construction and Acceptance of Hygienic Room 3 Terms and Definitions For the purposes of this standard, the following terms and definitions apply. 3.1 colony forming units microbial colony formed from reproduction of one or several microorganisms after microbial culture, which is referred to as CFU, and is generally expressed in the count of microorganisms 3.2 airborne microbe count of visible colony forming units reproducing under suitable culture condition in special culture medium through collecting living microbial particles in the air with the method referred in this standard 3.3 airborne microbe concentration count of colony forming units of airborne microbes per unit volume of air, expressed in terms of count concentration, in unit of CFU/m3 or CFU/L

Foreword II 1 Scope 2 Normative References 3 Terms and Definitions 4 Test Methods 5 Test Rules Annex A (Normative) Arrangement of Sampling Points in Clean Room (Zone) Annex B (Normative) Sterilization and Preparation of Culture Media Annex C (Informative) Technical Requirements for Airborne Microbe in Clean Room (Zone)