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GB/T 25916.2-2010: Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 25916.2-2010 | English | 274 |
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Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data
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GB/T 25916.2-2010
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Basic data | Standard ID | GB/T 25916.2-2010 (GB/T25916.2-2010) | | Description (Translated English) | Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C70 | | Classification of International Standard | 13.040.35 | | Word Count Estimation | 14,119 | | Date of Issue | 1/14/2011 | | Date of Implementation | 5/1/2011 | | Quoted Standard | GB/T 25916.1-2010 | | Adopted Standard | ISO 14698-2-2003, IDT | | Regulation (derived from) | Announcement of Newly Approved National Standards 2011 No. (No. 167 overall) 2 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Standard specifies a general method to assess microbiological data and general method to estimate risk areas live particle sampling results. Where applicable, this standard should be used in conjunction with Part 1 of this standard. | GB/T 25916.2-2010: Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data
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Cleanrooms and associated controlled environments Biocontamination control Part 2. Evaluation and interpretation of biocontamination data
ICS 13.040.35
C70
National Standards of People's Republic of China
Cleanroom and associated controlled environments
Biological Pollution Control Part 2.
Assessment and analysis of biological pollution data
Biocontaminationcontrol-Part 2.
(ISO 14698-2.2003, IDT)
Issued on. 2011-01-14 2011-05-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
GB/T 25916 "clean rooms and associated controlled environments Biological Pollution Control" is divided into two parts.
--- Part 1. General principles and methods;
--- Part 2. Evaluation and analysis of biological contamination data.
This part of GB/T 25916 Part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 14698-2.2003 "clean rooms and associated controlled environments biofouling control
Part 2. Evaluation and Analysis of "biological pollution data.
This part of the National Clean rooms and associated controlled environments Standardization Technical Committee (SAC/TC319) and focal points.
This section is responsible for drafting. Jiangsu Su net Technology Co., Ltd., China Electronic Systems Engineering Second Construction Co., Ltd., China Power Investment Project
Detection assessment center.
This section participated in the drafting unit. China Institute of Metrology, National Biological Protective Equipment Engineering Technology Research Center, Suzhou Su net Group
Aetna air Technology Co., Ltd., China Sinopec Shanghai Engineering Co., Ltd., Hideaway purification equipment Engineering Co., Ltd., Hunan access
Habitat Inspection and Quarantine Technology Center, Beijing Fu game Biosafety Technology Co., Ltd. Beijing North Tianyu decorative.
The main drafters of this section. Jiang Weikang, car Fengxiang, Qi built the city, Shihong Ping, Wang Hongjun, Xu torch, Ah Meng Zhao, Ning Minjie, Wang Li,
Zhu Jinguo, Kim Jin, Chen Jianghao, with Shao Bing, Wang Daqian.
Introduction
Biological pollution data according to the principles and methods of the standard Part 1 collected in this section gives a general method of evaluation. The Party
Method can also be used to assess the biological contamination of other data acquisition systems.
Cleanroom and associated controlled environments
Biological Pollution Control Part 2.
Assessment and analysis of biological pollution data
1 Scope
General methods section GB/T 25916 gives assessment of microbiological data and the estimated risk areas are generally square living particle sampling results
law. Where applicable, this section should be used in conjunction with Part 1 of this standard.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 25916.1-2010 cleanroom and associated controlled environments Biological Pollution Control Part 1. General principles and methods
(ISO 14698-1.2003, IDT)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Intervention value actionlevel
User-set value micro-organisms in a controlled environment. When this value is exceeded, the need for immediate intervention, including the identification of causes and corrective actions.
3.2
Warning value alertlevel
User-set value micro-organisms in a controlled environment, the possible deviation from the normal condition to give early warning.
Note. When the value exceeds the warning should be increased focus on the process.
3.3
File Index audittrail
Entry documents or documents related to the chain, could then traced information.
3.4
Biological pollution biocontamination
Live particle materials, equipment, personnel, surface, liquid, gas or air pollution.
3.5
Cleanroom cleanroom
Airborne particle concentration controlled room, constructed and used to make the room accessible, resulting particle retention minimal room
Other relevant parameters in the temperature, humidity, pressure controlled as required.
[GB/T 25915.1-2010,2.1.1] [2]
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