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International Standards for Biological Safety Cabinet (BSC)

Currently, there are many biological safety cabinet-relating standards throughout the world. These standards have been playing important roles in regulating manufacturing processes and testing procedures for a long time. With those participations, biological safety cabinets are designed and tested internally and externally to achieve these up-to-date standards as you may see on the markets. Below is a list of international standards in the BSCs world.

 

 

1. NSF/ANSI 49


The NSF Biosafey Cabinetry Program was initiated over 25 years ago at the request of the regulatory community, including the Centers for Disease Control (CDC), National Institute of Health (NIH), and the National Cancer Institute (NCI).

 

The first phase of the program was the development of NSF/ANSI Standard 49 for evaluation of Class II laminar flow biological safety cabinets. The standard was completed in 1976, followed by the implementation of a testing and certification program to that standard, titled the Biosafety Cabinetry Certification Program.

 

The third and final stage was completed in 1993, titled the Biosafety Cabinet Filed Certifier Accreditation Program.

 

This certification program is also accredited by the American National Standards Institute (ANSI) and recognized as the most practical and leading standard regarding the certification of Class II Biosafety Cabinet throughout the United States.

 

This NSF Standard 49 applies to class II (laminar flow) biosafety cabinetry designed to minimize hazards inherent in work with agents to biosafety levels 1, 2, 3, or 4. It also defines the tests that shall be passed by such cabinetry to meet this Standard. This Standard includes basic requirements for the design, construction, and performance of biosafety cabinets that are intended to provide personnel, product, and environmental protection. The most up-to-date version of the standard is NSF/ANSI 49-2009.

 

More information: www.nsf.org

 

 

2. EN 12469


EN 12469 or to give its full title in the UK, BS EN 12469: Biotechnology  Performance criteria for microbiological safety cabinets is the current and only CEN (European) standard for microbiological safety cabinets (MSCs).

 

This standard is the new harmonized Eurupean standard published by CEN, the European Committee for Standardization. It replaces related standards from countries in Europe including Biological Safety Cabinets: British Standard BS 5726, French Standard NF X44-201: 1984 and German Standard DIN 12950.


Again, EN 12469 is the only one remaining active and widely accepted standard for microbiological safety cabinets using in Europe.

 

More information: www.cenorm.be

 

 

3. BS 5726


This British Standard 5726, Microbiological safety is written in four parts with parts 1 and 3 being mandatory while parts 2 and 4 are only recommendations. In January 2000, the European Standard EN 12469 replaced part 1 and 3 of BS 5726. However, as EN 12469 does not cover installation or commissioning of MSCs, BS 5726 must be referenced.

 

BS 5726-1:1992  Microbiological safety cabinets. Specification for design, construction and performance prior to installation.

 

BS 5726-2:1992  Microbiological safety cabinets. Recommendations for information to be exchanged between purchaser, vendor and installer and recommendations for installation.

 

BS 5726-3:1992  Microbiological safety cabinets. Specification for performance after installation.

 

BS 5726-4:1992  Microbiological safety cabinets. Recommendations for selection, use and maintenance.

 

 

4. JIS K3800


The Japanese Industrial Standard (JIS) K3800 covers performance and safety requirements for class II biological safety cabinets.