All about biosafety cabinet standards

Biological safety cabinets, also known as microbiological safety cabinets, have been widely recognized as primary containment devices in dealing with biohazards. 

Example of a Biosafety Cabinet
Photo credits from: www.escoglobal.com

These biosafety cabinets are used to provide personnel, environment and product protection. The terms should only be applied to those devices that meet the requirements based on their construction, airflow velocities and patterns, and their exhaust systems.

The evolution of these containment devices prompted the need for consistency in its construction and performance. Moreover, the cabinet industry continues to grow so it is imperative to develop uniformity of these products throughout the world. As a result, various not-for-profit organizations created standards for biological safety cabinets.

The standards for biological safety cabinets are used to set the minimum requirements for manufacturers to comply with in terms of the products’ construction and performance criteria. 

In general, the major international standards in use today put emphasis on the biosafety cabinet’s performance in terms of providing protection to the worker and environment, and product if applicable.

International Standards for Biological Safety Cabinets

The following are the major international standards for Biological Safety Cabinets:

1. NSF/ ANSI 49.

   

   Photo credits from:
   www.nsf.org

    The NSF International Biological Safety Cabinetry Program was initiated during the 1970s. This standard gained official recognition from American National Standards Institute (ANSI) in 2002. It specifies the requirements for both the biosafety cabinet construction and performance criteria. In addition, reliable operation, durability, cleanability, noise level, and illumination control, vibration control, and electrical safety of the cabinet are checked as well.
2. EN 12469.  It is the harmonized European standard for microbiological safety cabinets, replacing the former German DIN 12950, British BS5726 and French NF X44-291:1984 standards in 2000. Similar to the NSF/ANSI 49, it specifies the requirements for both the cabinet’s construction and performance criteria. Though EN 12369 standard is based from NSF/ANSI 49, there are several differences between the two.                  
3. Underwriters Laboratories Inc. (UL). UL is an independent, not-for-profit product safety testing and certification organization and is one of the most recognized conformity assessment providers in the world. In order for a biosafety cabinet to be certified by NSF, it should conform to UL Standard 61010A-1 which covers electrical equipment for laboratory use. 
   
   
4. JIS K 3800. This standard is also known as the Japan Industrial Standard. The certification is performed by Japan Air Cleaning Association (JACA). This standard specifies performance, structure, and material and test method of Class II biological safety cabinets. The Class II biological safety cabinets specified in this standard are Type A, Type B1, Type B2 and Type B3. The cabinets should satisfy the requirements established by Minister of Health, Labor and Welfare based on the Ministerial Ordinance No. 99 of the Ministry of Health and Welfare in 1998.
5. AS 2252. This standard is also known as the Australian standard, was prepared by the Australian members of the Joint Standards Australia/Standards New Zealand Committee ME-060. It supersedes AS/NZS 2647:2000. This standard specifies requirements for biological safety cabinets including installation and use. For Class I biological safety cabinet, emphasis is given to personnel and environment protection. For Class II biological safety cabinet, its design should provide personnel, environment and product protection.

   

   Photo credits from:
   www.standards.org.au

6. SFDA YY 0569. The State Food and Drug Administration YY 0569 is the Chinese Standard for biological safety cabinets. It is modeled on both the EN 12469:2000 and NSF49:2002. This standard adopted the KI-Discus test from the European standard. Even though YY 0569 is based from the two major international standards, there are some notable improvements, i.e. instant display for air exchange rate and air intake, audio and visual warning system, to alert workers to performance malfunctions of biological safety cabinets. It is similar to NSF in such it recognizes four types of Class II BSCs. In summary, there are aspects unique to NSF and EN standards that are used as basis for YY 0569. 

Any of these standards can be used since they validate the biosafety cabinet's performance (mainly to provide protection to worker, environment and product). However, it is important to note that most biosafety cabinets in use today are certified based on  the standard  each country uses. For example, Europeans use EN certified cabinets while Americans use NSF certified cabinets. No matter what standard to follow, the effectiveness of the biosafety cabinet to provide protection greatly depends on how the user operates the equipment.

Sources:

1. Centers for Disease Control and Prevention. Appendix A – Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets. USA. Centers for Disease Control and Prevention. Available from: http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_appendixA.pdf [Accessed September 2, 2015].
2. Esco. 2013. Myths and Facts about Biosafety Cabinets. Singapore. Esco Micro Pte. Ltd. [Accessed September 3, 2015].
3. Esco. 2015. Learn about International Standards. Singapore. Esco Micro Pte. Ltd. Available from http://www.escoglobal.com/resources/learn-about-international-standards/16/ [Accessed September 2, 2015].
4. Hu Longfei, et. al. Chinese Biosafety Laws and Regulations, Including Matters of Biosecurity and Oversight of Genetic Engineering Activities. China. Available from http://cns.miis.edu/stories/pdf_support/070917_hu.pdf [Accessed September 4, 2015].
5. IHS Engineering 360. 2015. Standard: JSA – JIS K 3800, Class II Biological Safety Cabinets. New York, USA. IHS Engineering 360. Available from http://standards.globalspec.com/std/1296600/jsa-jis-k-3800 [Accessed September 4, 2015].
6. Lin Xiang Qian. 2012. Comparison between EN 12469:2000 and ANSI/ NSF 49:2002 Standards. Singapore. Esco Micro Pte. Ltd. [Accessed September 3, 2015].
7. NSF International. 2015. NSF/ANSI 49: Biosafety Cabinetry Certification. USA. NSF. Available from http://www.nsf.org/services/by-industry/pharma-biotech/biosafety-cabinetry/nsf-ansi-49-biosafety-cabinetry-certification/ [Accessed September 2, 2015].
8. Standards Australia. 2009. Controlled environments Part 2: Biological safety cabinets Class II – Design. Australia. Standards Australia. Available from https://www.google.com.ph/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&cad=rja&uact=8&ved=0CCkQFjACahUKEwintru95dnHAhUEGY4KHUKbDEQ&url=http%3A%2F%2Finfostore.saiglobal.com%2Fstore%2FPreviewDoc.aspx%3FsaleItemID%3D1662060&usg=AFQjCNF7bvC332iEUNcYYH8M2XeB5FeQjA&sig2=Cx-KGW55obp0vNmmiH76Sg&bvm=bv.101800829,d.c2E [Accessed September 3, 2015].