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JJF 1815-2020: Calibration Specification for Class II Biosafety Cabinets
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Calibration Specification for Class II Biosafety Cabinets
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JJF 1815-2020
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Basic data | Standard ID | JJF 1815-2020 (JJF1815-2020) | | Description (Translated English) | Calibration Specification for Class II Biosafety Cabinets | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A50 | | Classification of International Standard | 17.020 | | Word Count Estimation | 53,596 | | Date of Issue | 2020 | | Date of Implementation | 2020-04-17 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 1815-2020: Calibration Specification for Class II Biosafety 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.
Calibration Specification for Class II Biosafety Cabinets
National Measurement Technical Specification of the People's Republic of China
Calibration standard for Class Ⅱ biological safety cabinet
2020-01-17 release
2020-04-17 Implementation
Issued by the State Administration of Market Supervision and Administration
Calibration standard for Class Ⅱ biological safety cabinet
Focal point. National Biometrics Technical Committee
Main drafting unit. China Academy of Metrology
Participated in the drafting unit. Zhejiang Institute of Metrology
Suzhou Metrology and Testing Institute
Jiangsu Academy of Metrology
Beijing Academy of Metrology and Testing Science
This specification entrusts the National Biometrics Technical Committee to interpret
The main drafters of this specification.
Sui Zhiwei (Chinese Academy of Metrology)
Gao Yunhua (Chinese Academy of Metrology)
Participating drafters.
Yu Xiaobo (Zhejiang Institute of Metrology)
Li Long (Suzhou Metrology and Testing Institute)
Cui Hongen (Jiangsu Institute of Metrology)
Xiaoyang Wang (Beijing Institute of Metrology and Testing Science)
Sha Yuebing (Zhejiang Institute of Metrology)
table of Contents
Introduction (Ⅲ)
1 Scope (1)
2 References (1)
3 Terms and units of measurement (1)
3.1 Biological media (1)
3.2 Biological hazards (1)
3.3 Cross-contamination (1)
3.4 Product protection (1)
3.5 Airflow (1)
3.6 Nominal width of biological safety cabinet (2)
3.7 Biological safety level (2)
3.8 Biological safety cabinet (3)
3.9 Nominal value of flow rate (3)
3.10 Umbrella cover exhaust connection (3)
3.11 Direct exhaust connection (3)
3.12 High efficiency filter (3)
3.13 Polydisperse aerosol (3)
3.14 Work area (4)
3.15 Workbench (4)
3.16 Front window (4)
3.17 Height of front window operating port (4)
3.18 Protection factor (4)
4 Overview (4)
5 Metrological characteristics (5)
6 Calibration conditions (6)
6.1 Environmental conditions (6)
6.2 Standards and supporting equipment for calibration (6)
7 Calibration items and calibration methods (8)
7.1 Visual inspection (8)
7.2 Downflow velocity (8)
7.3 Inflow velocity (9)
7.4 Airflow mode (11)
7.5 Cleanliness (12)
7.6 Illumination (12)
7.7 Noise (13)
7.8 High efficiency/ultra high efficiency filter leak detection (14)
7.9 Protection of personnel, products and cross-contamination (16)
8 Expression of calibration results (22)
9 Recalibration time interval (22)
Appendix A Potassium Iodide Method (23)
Appendix B Calibration Original Record Format (28)
Appendix C Calibration Certificate (Inner Page) Format (32)
Appendix D Example of Measurement Uncertainty Evaluation of Calibration Results of Class Ⅱ Biological Safety Cabinet (33)
Introduction
The preparation of this specification is based on JJF 1001-2011 "General Measurement Terms and Definitions", JJF 1071-2010 "Country
"Measurement Calibration Rules" and "JJF 1059.1-2012" Measurement Uncertainty Evaluation and Expression "as the basis and basis
according to. The calibration method and measurement characteristics are mainly referred to BSEN12469..2000 "Biotechnology Microbiological Safety Cabinet
Performance standards "(Biotechnology-Performance criteria for microbiological safetycabinets),
NSF/ANSI49-2018 "Biosafety cabinet design, structure, performance and on-site certification" (BiosafetyCabin-
etry-Design, Construction, Performance, and Field Certification), ISO 14644-1.
2015 `` Clean Room and Related Controlled Environment Part 1. Classification of Air Cleanliness Based on Particle Concentration '' (Clean-
roomsandassociatedcontroledenvironments Part 1. Classificationofaircleanliness
byparticleconcentration), BS5726-3..1992 "Microbiological safety cabinet specifications Part 3. After installation
Performance Specification (Microbiologicalsafetycabinets Part 3. Specification for performance after
instalation), WS233-2017 "General Guidelines for Biosafety of Pathogenic Microbiology Laboratories", YY0569-2011
"Class II Biosafety Cabinet".
This specification is the first release.
Calibration standard for Class Ⅱ biological safety cabinet
1 Scope
This specification applies to the calibration of Class II biological safety cabinets, and the calibration of the same principle parts of Class I and III biological safety cabinet
Can refer to the implementation of this specification.
2 Reference documents
This specification refers to the following documents.
BSEN12469..2000 Performance Standards for Biotechnology Microbiological Safety Cabinet (Biotechnology-Per-
formancecriteriaformicrobiologicalsafetycabinets)
NSF/ANSI49-2018 biological safety cabinet design, structure, performance and on-site certification (Biosafety
Cabinetry. Design, Construction, Performance, andFieldCertification)
ISO 14644-1..2015 Clean rooms and related controlled environments Part 1. Clean air according to particle concentration
Clarity classification (CleanroomsandassociatedcontroledenvironmentsPart 1. Classification
ofaircleanlinessbyparticleconcentration)
BS5726-3..1992 Specification for microbiological safety cabinets. Part 3. Performance specifications after installation (Microbiological
safetycabinets Part 3. Specificationforperformanceafterinstalation)
WS233-2017 General Guidelines for Biosecurity in Pathogenic Microbiology Laboratories
For dated reference documents, only the dated version applies to this specification; for those without date references
The latest version (including all amendments) is applicable to this specification.
3 Terms and units of measurement
As defined in BSEN12469..2000, NSF/ANSI49-2018 and ISO 14644-1..2015 and below
Terms and definitions apply to this specification.
3.1 Biological agents biological agents 【NSF/ANSI49-2018】
All microorganisms and biologically active substances.
3.2 Biohazard [NSF/ANSI49-2018]
Direct or potential hazards caused by biological media.
3.3 Crosscontamination [BSEN12469-2000]
Substances outside the target accidentally enter the target.
3.4 Product protection productprotection [BSEN12469-2000]
The biological safety cabinet prevents contaminants from outside air from spreading into the working area of the safety cabinet through the front window operation port.
3.5 Airflow
3.5.1 Downflow velocity downflow velocity 【NSF/ANSI49-2018】
The airflow velocity from the vertical above the biological safety cabinet filtered by the high-efficiency filter to the work area provides production
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