Biosafety Cabinet Standards & Testing

Biosafety Cabinet Standards

The purpose of a Biosafety Cabinetry Standard is to

establish minimum requirements for:
• Materials
• Design
• Construction
• Performance
The Standards are designed to protect:
• Personnel
• Product
• Environment

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 Biosafety Cabinet Standards

The Standard details requirements for

performance testing (type tested) as well as field
certification testing (individual unit) to prove they
are providing the protection to product/user that
they should.

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 Current International Standards
Current International standards relating to Biosafety Cabinetry

• European Union – EN 12469

• USA – NSF/ANSI 49
• Russian Federation – GOST R EN 12469-2010
• Japan – JIS K 3800
• China – SFDA YY 0569

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Other Guidance Documentation

WHO Laboratory biosafety manual, 4th edition: Biological safety cabinets and
other primary containment devices

https://www.who.int/publications/i/item/9789240011335
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 Prior to EN standards (2000)

• Germany - DIN 12950 Teil 10 - Laboratory furniture; safety

cabinets for microbiological and biotechnological work;
requirements and testing
• France - AFNOR NF X44-201 - Microbiological safety cabinets.
Definitions. Classification. Characteristics. Safety requirements.
Tests.
• UK - BS 5726 Parts 1–4 - Microbiological safety cabinets.
Information to be supplied by the purchaser to the vendor and to
the installer, and siting and use of cabinets. Recommendations
and guidance

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 Introduction to EN 12469:2000

Biotechnology – Performance criteria for microbiological safety cabinets (MSC*)

The European standard specifies basic requirements for microbiological safety cabinets
(MSCs) with respect to safety and hygiene.

“This European Standard sets the minimum

performance criteria for safety cabinets for work
with microorganisms and specifies test procedures
for microbiological safety cabinets with respect to
protection of the worker and the environment,
product protection and cross contamination”
EN12469:2000, pg 4 Scope

*MSC (in EU) is interchangeable with BSC (in US) – we will use BSC on the course

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 Introduction to NSF/ANSI 49 - 2020
Biosafety Cabinetry: Design, Construction, Performance, and Field Certification.

• NSF maintains the American National Standard (NSF/ANSI 49,

also recognized globally), tests and certifies BSC model lines,
and tests and accredits BSC field certifiers.
• NSF evaluates the design, construction, and performance of
class II laminar flow biosafety cabinets to NSF/ANSI Standard
49.
• NSF provides personnel accreditation for individuals who are
trained to field certify biosafety cabinets (field certification is a
routine maintenance requirement).
• Annex F: Field tests

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 Why the need for Certification?

• More than 40% of all BSCs are sold into countries with no
routine field certification infrastructure
• Limited access to qualified personnel
• Unaware of recommendations regarding use and
maintenance
• Current framework may consider maintenance cost
prohibitive
• Improper equipment selection - for example, using
flammable chemicals in an inappropriate cabinet type, or
open flames
Stanford University BSC Fire
(due to open flames)

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 Issues on a Global Level

Lack of understanding of how BSCs work

For example, assumption of universal inflow and downflow
velocities
User issues:
• Items on top of BSC, blocking exhaust
• Placing BSCs in high traffic areas
• Placement of BSC close to HVAC
• Not working from clean to dirty
• Too many users per BSC
• Use of inappropriate disinfectants

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 NSF/ANSI 49: Biosafety Cabinetry
Certification & Accreditation
• Ongoing compliance to Standard 49 – if
new tests are added, manufacturers retest

• Any changes to NSF Certified products must

be approved

• Biosafety cabinets are retested every five

years, even with no changes https://info.nsf.org/Certified/Biosafety-Certifier/index.asp?standard=0ACBASIC

In January 2018, NSF expanded its accreditation program for BSC field certifiers with
two levels of accreditation available outside of North America:

1) Basic (2 week) – to which this Training course aligns itself

2) Enhanced (1 year) – for professionals already working in BSC maintenance

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 What is Field Certification?

• Ensures airflow settings are correct

• Verifies HEPA filters are not damaged or loaded
to the point that the airflow balance is impacted
• Visualizes airflow with smoke tests
• Verification that alarms are functioning as
intended (sash height, exhaust airflow volume,
etc.)
• Some optional user-comfort tests
• Subsequent updates to include engineer-led
decontamination of BSC prior to servicing

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 Quality Control of Field Certifiers

Accredited training provides the foundation of the quality control required for safely
working with BSCs and adherence to the Standards

vs.

Photo source: M. Roush, NSF

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 Evidence based findings

“In a survey of biosafety level (BSL) 2 and 3 laboratories in 7 countries in the Asia-Pacific region, 30% of Class
II BSCs tested were poorly designed, incorrectly installed, not certified, or being operated improperly.”
“In Thailand, an estimated 600 BSCs need annual certification, and in 2013, only 1 accredited certifier was
registered with the NSF International for BSC field certifications, and only 1 local company was known to
perform these services to NSF standards.”

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 Some Key concepts

•Below are a small selection of the many key concepts you will need to
know. These will be provided throughout the different activities in week
1.
• What are some of the similarities and differences between NSF 49 and EN
12469, especially in terms of the tests required for field certification?
• What does it mean for a BSC to be certified (type tested) to a standard by a
third party certification agency vs. field certified (individual unit)?
• How should field certifiers determine which standard to use when evaluating
a BSC that is already installed in a laboratory setting?
• When should BSCs be field certified?
• How does a certified field tester retain their NSF accreditation over time?
• How to produce a certification report and what should be included in the
report

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 NSF/ANSI 49 vs EN12469
Test NSF/ANSI 49 EN12469
Type Testing Biological test for operator protection, product protection Biological test for operator protection, product
and cross contamination protection and cross contamination

Downflow No requirement on downflow Requirement on downflow

Velocity Airflows must match those used when type tested Simpler test methods, must be between 0.25 and 0.5
Requires a larger test sample size and is more vigorous m/s

Inflow Using a direct inflow measurement (DIM) as the primary Performs inflow tests by measuring exhaust flow and
Velocity standard provides repeatable and accurate inflow back calculating the inflow.
measurements. But method not clear defined, this allows for calculation
BSC A2 requires at least 0.5 m/s errors and any multiple sets of test data can provide
Airflows must match those used when type tested, using a different velocity values.
matching method BSC II requires >0.4 m/s
HEPA DOP Scan test to 0.01% penetration DOP Scan test to 0.01% penetration
Volumetric test to 0.005% penetration No specification for volumetric test or for repair of
Allows for repair of filters filters

Performance Requires that the Class II cabinet must function +/-0.025 EN does not have a matching specification.
Envelope m/s of the inflow and downflow set points. (Note UK in situ KI test)

You will be trained on tests in both NSF/ANSI 49 & EN12469

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 Which Standard to use?
How should field certifiers determine which standard to use when evaluating a BSC
that is already installed in a laboratory setting?

Look to whether the manufacturer type tested the BSC to EN 12469, NSF 49, etc. and field certify to
that standard and/or follow the manufacturer recommendations / guidelines

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 When to field certify BSCs

NSF/ANSI 49 recommends recertification after each of the following

events:

• After installation
• After repairs
• Annually
• After moving

Additionally in the event of an unforeseen event (i.e. Earthquake,

major building works) field certification may be required

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