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YY 0569-2011: Class Ⅱ biological safety cabinets
Status: Valid YY 0569: Evolution and historical versions
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Class Ⅱ biological safety cabinets
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YY 0569-2011
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Biological safety cabinets
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Basic data | Standard ID | YY 0569-2011 (YY0569-2011) | | Description (Translated English) | Class �� biological safety cabinets | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | 51,59 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Older Standard (superseded by this standard) | YY 0569-2005 | | Quoted Standard | GB/T 191-2008; GB 4793.1-2007; disinfection technical specifications (2002 edition) Ministry of Health | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the �� level biosafety cabinet terminology and definitions, classifications, materials, structure and performance requirements, test methods, inspection rules, signs, labels, brochures, packaging, transportation and storage requirements. This standard applies to grade �� biological safety cabinet (hereinafter referred to as safety cabinets). | YY 0569-2011: Class Ⅱ biological safety cabinets---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Class Ⅱ biological safety cabinets
ICS 11.140
C48
People's Republic of China pharmaceutical industry standards
Replacing YY 0569-2005
Level Ⅱ biological safety cabinet
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Ⅱ level security cabinet types and characteristics of 2
5 requires 3
6 Test methods 8
7 Inspection rules 27
8 label, tag 28
9 packaging, transportation and storage 29
Appendix A (informative) security cabinet installation recommendations 31
Annex B (informative) Recommended disinfection procedures 36
Preparation of Appendix C (normative) of Bacillus subtilis spore suspension of 38
Annex D (normative) sprayer calibration and selection 40
Appendix E (normative) potassium iodide method 42
Annex F (normative) Measurement circular and rectangular duct air volume 45
References 47
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard replaces YY 0569-2005 "Biological safety cabinets"; this standard compared with YY 0569-2005 standards, major changes in content
as follows.
--- Name to grade Ⅱ biological safety cabinets;
--- Additions and amendments to the "normative references";
--- Editorial modify the terms and definitions, further refine the definition of the work area, increasing the security cabinet front window opening height of a given operation
Righteousness; increased safety cabinets and safety cabinets hierarchical levels of protection are described in the definition of biological safety cabinets;
--- Remove Ⅰ and Ⅲ grade level content of biological safety cabinets, updating the definition of class Ⅱ biological safety cabinet, and grade Ⅱ A1 Safety Cabinet
Features modified (Ⅱ grade type A1 biological safety cabinet requirements for the cabinet parts are all biological contamination in the vacuum state or the negative
Pressure passage and surrounded by negative pressure ventilation systems);
--- Update efficient filter characteristics requirements;
--- Delete Workspace double vacuum structure, revised as A1, A2 and B1 Safety Cabinet all contaminated sites should be in a negative pressure state
Or surrounded by negative pressure zone, all contaminated parts Type B2 cabinet should be in a negative pressure state or direct discharge of the negative pressure zone
Surround;
--- Increasing the fan/motor content (fan/motor section further improve, specifically fans, lines, sensors, wiring diagrams, installation instructions
Claim);
--- Remove the differential pressure gauge performance requirements;
--- Increasing the sampling port Requirements. Level Ⅱ cabinet should be reserved for high efficiency filter upstream aerosol concentration sampling port;
--- Increasing the front window opening to reduce alarm;
--- Increased security cabinet airflow alarm fluctuations in decline and the inflow stream nominal values found, display the required value between;
--- Fan Performance Test explicitly allow only decline, and not more than 10%;
--- Increased ultraviolet lamp radiation intensity requirements, test methods and clear;
--- Clear cabinet leak test requirements of applicable law and drop the soap bubble method;
Revision table --- perfect noise-related information;
--- To increase the B-type cabinet efflux static pressure detecting port, static pressure test requirements;
--- Appendix C added Three methods for preparing the appropriate method "disinfection technical specifications" in the 2002 edition can refer to.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the State Food and Drug Administration, Beijing Medical Device Quality Supervision and Inspection Center.
This standard was drafted. Beijing Medical Device Testing, Su net Group Suzhou Aetna air Technology Co., Ltd., the Shanghai Shen scientific instrument
Co., Ltd, Jinan Xin Bessie Biological Technology Co., Ltd. Shanghai Rui Yang purification equipment.
The main drafters of this standard. Huguang Yong, Wang Zheng Qi, Pan Si-chun, Kim Jin, Wu Jun, Yuanwen Hu, Zhou Weihua.
Level Ⅱ biological safety cabinet
1 Scope
This standard specifies the terms and definitions grade Ⅱ biological safety cabinets, classification, materials, structure and performance requirements, test methods, inspection rules,
Signs, labels, brochures, packaging, transportation and storage requirements.
This standard applies to grade Ⅱ biological safety cabinets (hereinafter referred to as safety cabinets).
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 191-2008 Packaging - Pictorial signs
GB 4793.1-2007 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements
Disinfection technical specifications (2002 edition) Ministry of Health
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Biological Safety Cabinet biologicalsafetycabinet; BSC
Fume suction filter to prevent the operator and environmental exposure to experiment generated during biological aerosols.
Biological safety cabinet is divided into three levels. level Ⅰ biological safety cabinet, biological safety cabinets and grade Ⅱ Ⅲ class biological safety cabinet.
Ⅰ level security cabinet has a front window opening operation, the operator can operate through the front window opening in the security cabinet operation. Front window opening inward suction operation
Security vacuum airflow to protect operators; exhaust air is passed through HEPA filtered exhaust cabinet to protect the environment.
Ⅱ level security cabinet has a front window opening operation, the operator can operate in a secure cabinet through the front window opening operation, the front window opening inward suction operation
Negative pressure air stream to protect the operator's safety; HEPA filtered through downdraft to protect safety cabinet experiment items; airflow
The high efficiency filter after discharging the cabinet to protect the environment.
Ⅲ level security cabinet is closed, does not leak fume hood structure. By connecting people with the cabinet closed glove enforcement action in the security cabinet
Make. Downdraft filtered through high efficiency filter into the cabinet to protect the security cabinet test items; exhaust gas flows through the two high efficiency filter
Filter and then by incineration or for the protection of the environment through a high efficiency filter.
3.2
Biological factors biologicalagents
All microorganisms and biologically active substances.
3.3
Biohazard biohazard
Immediate or potential danger caused by a biological agent.
3.4
Cross-contamination crosscontamination
Accident outside material into the target object.
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