SIST EN 12469-2:2026

SLOVENSKI STANDARD
01-januar-2026
Biološke varnostne omare - 2. del: Biološke varnostne omare (BSC) razreda II
Biological safety cabinets - Part 2: BSC class II
Biologische Sicherheitswerkbänke - Teil 2: BSC Klasse II
Postes de sécurité biologique - Partie 2: BSC de type II
Ta slovenski standard je istoveten z: EN 12469-2:2025
ICS:
07.080 Biologija. Botanika. Zoologija Biology. Botany. Zoology
07.100.01 Mikrobiologija na splošno Microbiology in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 12469-2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2025
EUROPÄISCHE NORM
ICS 07.080
English Version
Biological safety cabinets - Part 2: BSC class II
Postes de sécurité microbiologique - Partie 2 : PSM de Biologische Sicherheitswerkbänke - Teil 2: BSC Klasse
type II II
This European Standard was approved by CEN on 5 October 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12469-2:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 5
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Tests . 7
5 Design and construction . 9
5.1 General. 9
5.2 Stability . 9
5.3 Ergonomics . 9
5.4 Lighting . 9
5.4.1 General. 9
5.4.2 Testing . 9
5.5 UV lamps . 9
5.6 Sound and vibrations. 9
5.7 Glazing . 9
5.7.1 General. 9
5.7.2 Testing of the sash . 9
5.8 Carcass . 10
5.8.1 General. 10
5.8.2 Testing . 10
5.9 Filter system . 11
5.9.1 General. 11
5.9.2 Liquid protection test . 11
5.10 Alarm indicators and alarms . 11
5.10.1 Alarm indicators . 11
5.10.2 Alarms . 11
5.11 Gas supply . 12
5.12 Electrical safety . 12
5.13 Stop / start of BSC . 12
5.14 Connection to exhaust systems . 12
5.15 Cleanability . 12
5.16 Decontaminability . 12
5.17 Spillage tray . 12
5.18 Intake grille . 12
6 Airflow velocities . 12
6.1 General. 12
6.2 Downflow . 12
6.2.1 General. 12
6.2.2 Testing . 13
6.3 Inflow . 15
6.3.1 General. 15
6.3.2 Testing . 15
6.3.3 Alternative test methods . 19
6.4 Visualization of airflows . 19
6.4.1 General . 19
6.4.2 Material and equipment . 19
6.4.3 Procedure . 19
6.4.4 Documentation . 20
7 Protective functions . 20
7.1 General . 20
7.2 Operator protection . 20
7.2.1 General . 20
7.2.2 Testing . 20
7.3 Product protection . 21
7.3.1 General . 21
7.3.2 Testing . 21
7.4 Cross-contamination protection . 21
7.4.1 General . 21
7.4.2 Testing . 21
7.5 Stability of the protective functions . 21
7.5.1 General . 21
7.5.2 Testing . 21
8 Accompanying documents . 21
8.1 Operating manual . 21
8.2 Equipment logbook . 21
8.3 Brief instructions for use . 22
9 Marking . 22
10 Installation and maintenance . 22
Annex A (normative) Test for operator protection . 23
A.1 Microbiological test . 23
A.1.1 General . 23
A.1.2 Material and equipment . 23
A.1.3 Test procedure . 28
A.1.4 Calculation and expression of results . 30
A.1.5 Acceptance criteria . 30
A.2 Potassium iodide (KI) method . 31
A.2.1 General . 31
A.2.2 Material and equipment . 32
A.2.3 Test procedure . 33
A.2.4 Acceptance criteria . 34
Annex B (normative) Test for product protection . 35
B.1 General . 35
B.2 Material and equipment . 35
B.2.1 Reagents . 35
B.2.2 Equipment . 35
B.3 Test procedure . 36
B.4 Calculation and expression of results . 37
B.5 Acceptance criteria. 37
Annex C (normative) Test for cross-contamination protection . 38
C.1 General. 38
C.2 Material and equipment . 38
C.2.1 Reagents . 38
C.2.2 Equipment . 38
C.3 Test procedure . 39
C.4 Calculation and expression of results . 40
C.5 Acceptance criteria. 40
Annex D (normative) Test of the stability of protective functions . 41
D.1 General. 41
D.2 Material and equipment . 41
D.3 Test procedure . 41
D.4 Calculation and expression of results . 42
D.5 Acceptance criteria. 42
Bibliography . 43

European foreword
This document (EN 12469-2:2025) has been prepared by Technical Committee CEN/TC 332 “Laboratory
Equipment”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2026, and conflicting national standards shall be
withdrawn at the latest by May 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
1 2
, prEN 12469-4:— and
This document, together with EN 12469-1:2025, prEN 12469-3:—
EN 12469-5:2025, will partially supersede EN 12469:2000.
— the structure has been changed to emphasize different classes of biological safety cabinets (BSC);
— additional test of the stability of protective functions;
— the text of the entire document has been revised and references have been updated.
EN 12469 consists of the following parts, under the general title Biological safety cabinets:
— Part 1: Classes, terminology and basic requirements
— Part 2: BSC class II
— Part 3: BSC class III
— Part 4: BSC class I
— Part 5: Installation, commissioning and routine testing
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United
Kingdom.
Under preparation.
Under preparation.
Introduction
Biological safety cabinets (BSC) are designed to protect the operator and the environment against the
risks associated with the handling of biological agents. Depending on the classes, a BSC can additionally
protect the product.
Each BSC class has its own design and performance criteria. The choice of a BSC class depends on the type
of protection required and the assessment of the risk to be controlled.
EN 12469 describes the BSC classes, their design, correct usage, and testing principles.
This document is a product standard. Occupational health and safety assessments methods are not
included.
1 Scope
This document specifies the specific requirements for class II BSC with respect to design, construction,
safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test
procedures with respect to protection of the operator, the environment and product protection including
cross-contamination.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 12469-1:2025, Biological safety cabinets - Part 1: Classes and basic requirements
EN ISO 14644-7:2004, Cleanrooms and associated controlled environments - Part 7: Separative devices
(clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 12469-1:2025 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
4 Tests
For the different test sets different requirements shall be verified. Table 1 gives an overview about the
test sets and the requirements to be verified for the different sets.
Table 1 — Requirements to be verified for different tests
Clause Requirement: X = mandatory, R = recommended, O = optional
Type test Factory test Commissioning Routine test
5 Design and construction
5.1 General X  X
5.2 Stability X
5.3 Ergonomics X
5.4 Lighting X
a X
5.5 UV lamps
5.6 Sound and vibration X
5.7 Glazing X
X
5.8 Carcass
X X X X
5.9 Filter System
X
5.9.1 Liquid protection test
5.10 Alarm Indicators and alarms
X
5.10.1 Alarm indicators
X X X X
5.10.2 Alarms
X R X R
a
5.11 Gas supply
X X
5.12 Electrical safety
X X X X
5.13 Stop/start of BSC
X X
a
5.14 Connection to exhaust system
5.15 Cleanability X
5.16 Decontaminability X
5.17 Spillage tray X
5.18 Intake grille X
6 Airflow velocities
6.2 Downflow X X X X
6.3 Inflow X X X X
6.4 Visualization of airflows X  X X
7 Protective functions
7.2 Operator protection
According to A.1 X
According to A.2 O  O O
X
7.3 Product protection
X
7.4 Cross-contamination protection
X
7.5 Stability of the protective functions
b
8 Accompanying documents
X X X X
8.1 Operating manual
X X X X
8.2 Equipment logbook
X X X X
8.3 Brief instruction for use
Clause Requirement: X = mandatory, R = recommended, O = optional
Type test Factory test Commissioning Routine test
9 Marking X X X X
a
if installed
b
for type test check content, for other test check if the documents are available
5 Design and construction
5.1 General
The general design and construction shall be in accordance with EN 12469-1:2025.
5.2 Stability
The stability shall be in accordance with EN 12469-1:2025.
5.3 Ergonomics
The ergonomics shall be in accordance with EN 12469-1:2025.
5.4 Lighting
5.4.1 General
The lighting shall be in accordance with EN 12469-1:2025.
5.4.2 Testing
The lighting shall be tested according to EN 12469-1:2025.
For testing the following measuring grid shall be used: the first measuring line on the work surface shall
start 10 cm behind the intake slots. Starting point from left to right is 15 cm from the side walls. Divide
the lines into equally spaced sections with a maximum of 20 cm. The second line shall be 20 cm behind
the first line.
5.5 UV lamps
If installed, the UV lamps shall be in accordance with EN 12469-1:2025.
5.6 Sound and vibrations
Sound and vibration levels shall be in accordance with EN 12469-1:2025.
5.7 Glazing
5.7.1 General
The glazing material and construction shall be in accordance with EN 12469-1:2025.
5.7.2 Testing of the sash
5.7.2.1 Test procedure
Set the sash to the test sash position. Disconnect one of the suspension devices of the sash.
Repeat the test with the other suspension device.
5.7.2.2 Acceptance criteria
The sash shall not endanger the operator in case of single fault.
5.8 Carcass
5.8.1 General
The carcass shall be in accordance with EN 12469-1:2025.
For a BSC class II the carcass includes the exterior surfaces, welds, gaskets and seals etc. The carcass shall
be leak tight.
There are two alternative methods to check leak tightness. The two methods are described in 5.8.2.1 and
5.8.2.2.
5.8.2 Testing
5.8.2.1 Pressure decay test
5.8.2.1.1 Material and Equipment
— manometer, capable of reading in the range 0 Pa to 500 Pa with an accuracy of ± 5 Pa
— plates to seal opening as needed (provided by the manufacturer).
5.8.2.1.2 Test procedure
The BSC is tested for leakage by subjecting it to an internal pressure.
— seal all openings in the cabinet by any convenient means. The sash can be removed
— attach a manometer to the test area to indicate the internal pressure relative to the room
— pressurize the cabinet to 250 Pa + 20 Pa
— turn off the pressurizing air and measure the internal pressure after 1 min.
5.8.2.2 Constant pressure test
5.8.2.2.1 Material and Equipment
— a volumetric flow meter with an accuracy of 0,1 times the expected leakage rate. Example for class
−1 −3
4 as per Table 2 the accuracy is 0,1 ∙ 1,67 l ∙ min ∙ m
— manometer, capable of reading in the range 0 Pa to 500 Pa. With an accuracy of ± 5 Pa
— plates to seal any opening as needed (provided by the manufacturer).
5.8.2.2.2 Test procedure
— seal all openings in the cabinet by any convenient means
— attach a manometer to the test area to indicate the interior pressure
— pressurize the cabinet to an internal positive pressure of 250 Pa + 20 Pa.
The volumetric flow meter is installed in the hose via which the test air is fed into the cabinet (positive
pressure test). For air feed, a very finely controllable positive pressure connection is required. The
introduced flow rate is regulated in order to maintain the positive pressure at its specific value. This flow
rate divided by the net volume of the cabinet corresponds to the hourly leak rate.
To avoid the effect of atmospheric pressure and temperature changes, the measurement shall be less than
10 min long.
5.8.2.3 Acceptance criteria
The leak tightness shall not be less than class 4 according to EN ISO 14644-7:2004, Table E.1 (see
Table 2).
Table 2 — Comparison of classification of containment enclosures according to their hourly
leakage rate and pressure loss
Class Hourly leak rate Calculated pressure Calculated leakage
a rate per 1 m volume
loss per minute
of the cabinet
R Δp R
h V
Pa
-1 l/min
h
−4 −3
1 ≤ 5 ⋅ 10 0,84 8,3 ⋅ 10
−3
2 < 2,5 ⋅ 10 4,2 0,041
−2
3 < 10 16,9 0,167
−1
4 < 10 168,9 1,67
a
at atmospheric pressure (101 325 Pa).
NOTE The calculation is based on requirements of EN ISO 14644-7:2004, Table E.1
5.9 Filter system
5.9.1 General
The filter system shall be in accordance with EN 12469-1:2025.
5.9.2 Liquid protection test
The liquid protection test shall be in accordance with EN 12469-1:2025.
5.10 Alarm indicators and alarms
5.10.1 Alarm indicators
The alarm indicators for type test shall be in accordance with EN 12469-1:2025.
5.10.2 Alarms
For class II BSC the critical parameters for alarms are:
— downflow: low and high alarm
— inflow: low and high alarm
— sash not in working position.
Check if audible and visual alarms are working correctly.
5.11 Gas supply
If installed, the gas supply shall comply with the requirements of EN 12469-1:2025.
5.12 Electrical safety
The electrical safety shall be in accordance with EN 12469-1:2025.
5.13 Stop / start of BSC
The stop / start shall be in accordance with EN 12469-1:2025.
5.14 Connection to exhaust systems
If the BSC is connected to an exhaust system, it shall be in accordance with EN 12469-1:2025.
5.15 Cleanability
The cleanability shall be in accordance with EN 12469-1:2025.
5.16 Decontaminability
The decontaminability shall be in accordance with EN 12469-1:2025.
5.17 Spillage tray
The spillage tray shall be in accordance with EN 12469-1:2025.
5.18 Intake grille
The design should ensure that the intake grill cannot be obstructed by operator's arms.
The delivery area for the air to the working space should be without interposed projections or cavities
that could interfere with containment performance.
6 Airflow velocities
6.1 General
The target values for airflow velocities, as specified by the manufacturer, are essential to ensure
comprehensive protection for the operator, environment, product, and against cross-contamination.
These four types of protection are detailed in Annex A (A.1), Annex B, and Annex C.
Achieving the correct balance between downflow and inflow velocities is critical to maintaining the
protective functions that a class II BSC offers.
Proper calibration and adherence to these specified airflow velocities are fundamental to the effective
operation and safety of the BSC.
6.2 Downflow
6.2.1 General
The downflow velocity specified by the manufacturer shall ensure that the intended protection function
of the BSC is met. The manufacturer’s specification shall be noted on the data plate of the BSC.
6.2.2 Testing
6.2.2.1 Material and equipment
For airflow velocity measurements an anemometer with the specifications given in Table 3 shall be used.
Table 3 — Specification of anemometers
Item Minimum requirements
Resolution 0,01 m/s (0 m/s to 1,00 m/s)
Accuracy ±(0,02 m/s + 5 % of reading) (0,20 m/s to 1,00 m/s)
For downflow velocities < 0,2 m/s, the manufacturer shall specify the appropriate measurement
methods and device specifications. Accuracy shall be at least 5 % of reading.
6.2.2.2 Test procedure
The below description, including Figure 1, specifies the minimum number of measuring points. An
alternative measuring grid may be used as long as the minimum number of measuring points is more
than described and the points are evenly distributed over the work surface.
The measuring probe of the anemometer shall not be hand-held during downflow measurements.
The measurements shall be done in a horizontal plane at 10 cm above the bottom edge of the sash in its
normal operating position.
The measurement and recording of the individual velocity component shall be performed perpendicular
to the airflow at regular intervals of 1,0 s or less over a period of at least 10 s.
This plane shall be divided in equal areas to be specified by the manufacturer with a maximum of
30 × 30 cm for each area.
The measuring points shall be at the centre of each area.

Key
Measuring Point (MP)
H 10 cm
F – B Front to Back (inner side of the window to inner back wall at a height of 10 cm)
S – S Side to Side (side wall to side wall)
X and Y ≤ 30 cm, maximum area width/depth (=maximum distance between measuring points)
X’ and Y’ X' = X / 2 and Y' = Y/2
Figure 1 — Grid for downflow velocity
An example of a downflow velocity measuring grid for a typical 180 cm BSC is given in Figure 2.
Dimensions in centimetres
Key
Measuring Point (MP)
Maximum spacing between measuring points 30 cm
F-B (Front to Back)
F – B  55,0 cm
Measuring Exact no. of MP's = (Distance F-B) / (Max distance between MP's) 1,8
Points
MP's round up = (Exact no. of MP's) rounded up 2
Y Distance between MP's = (Distance F-B) / (MP's Round up) 27,5 cm
Y’ Distance of the first and last MP (from Front and Back) = Y / 2 13,8 cm
S - S (side wall to side wall)
S - S  177,0 cm
MP's Exact = (Distance S-S) / (Max distance between readings) 5,9
Rounded up = (Exact no. of MP's) rounded up 6
X Distance between MP's = (Distance s-s) / (MP's Round up) 29,5 cm
X' First and last MP (from Side walls) = X / 2 14,8 cm
Figure 2 — Grid for downflow velocity – example
6.2.2.3 Expression of results
Velocity values shall be expressed in two decimal places.
Calculate by Formula (1) the average value v of the recorded velocities at each point in m/s. Round the
result to two decimal places:
1 n
(1)
vv=
∑
dfl i
i=1
n
where
n is the number of measurement points;
is the average downflow velocity in m/s;
v
dfl
is the recorded velocity at each point in m/s.
v
i
6.2.2.4 Acceptance criteria
Average value for the downflow velocity of the cabinet shall be in accordance with the manufacturer’s
specification (including tolerance value). All individual readings shall be within ± 20 % from the average
value.
6.3 Inflow
6.3.1 General
The inflow method specified by the manufacturer shall ensure that the intended protection functions of
the BSC are met and shall be described in the operating manual.
6.3.2 Testing
6.3.2.1 General
At least one of the following methods shall be used as a reference.
— measuring the air volume rate using an airflow capture hood at the front aperture
— measuring the air volume rate using an airflow capture hood at the exhaust
— velocity measurement at the reduced front aperture using an anemometer.
If alternate methods are used and described by the manufacturer they should correlate with one of the
above methods.
If a correction factor for the correlation of different methods is necessary, it shall be provided by the
manufacturer. This information shall be described in the manual and stated on the data plate.
6.3.2.2 Material and equipment
If an airflow capture hood is used, it shall meet the requirements specified in Table 4.
Table 4 — Specifications of airflow capture hood
Item Minimum requirements
Resolution 3
≤ 1 m /h
Maximum permissible error ±3 % of reading
3 3
±12 m /h at flows > 85 m /h
For airflow velocity measurements unidirectional thermal type, vane type or equivalent anemometers
according to Table 5 may be used.
Table 5 — Specifications of anemometers
Item Minimum requirements
Resolution 0,01 m/s (0,20 to 1,0 m/s)
0,1 m/s (>1,00 m/s)
Accuracy ±(0,02 m/s + 5 % of reading) (0,20 m/s to 1,00 m/s)
10 % of reading (>1,00 m/s)
6.3.2.3 Test procedure
6.3.2.3.1 Measurement at the front aperture with airflow capture hood
Follow the steps below in the order presented.
— place the device at the centre of the front aperture
— seal off open areas on the sides to take the entire volume flow into account during measurement
— take at least 5 non back pressure compensated readings and calculate the average.
Calculate the inflow velocity (m/s) by dividing the average inflow volume rate measured, by the area of
the front aperture (m ).
6.3.2.3.2 Measurement at the exhaust with airflow capture hood
Follow the steps below in the order presented.
— place the device over the BSC’s exhaust opening
— seal off open areas on the sides to take the entire volume flow into account during measurement
— take at least 5 non back pressure compensated readings and calculate the average.
Calculate the inflow velocity (m/s) by dividing the average exhaust volume measured, by the area of the
front aperture (m ).
6.3.2.3.3 Velocity measurement at a reduced front aperture
Follow the steps below in the order presented
— reduce the working aperture height according to the manufacture’s specification. The measuring line
is in the middle of the front aperture if not specified otherwise
— the measurement probe shall be positioned securely so that accurate and repeatable readings can be
taken
— measurements shall be taken at several points across the reduced front aperture:
The measuring line shall be divided into even sections as specified by the manufacturer, but with a
maximum of 20 cm between each measuring point, and with the side sections being half of the other
sections. See measuring grid in Figure 3.

Key
measuring Point (MP)
H height of the reduceded front aperture
H’ H/2, distance to the centre of the (reduced) front aperture
X maximum of 20 cm between the measuring points
X’ X/2, distance from the side walls to the first and last measuring point
‘S - S side wall to side wall
Figure 3 — Grid for inflow velocity test - reduced front aperture
An example of inflow velocity measuring points for a typical 180 cm BSC is shown in Figure 4.
Dimensions in centimetres
Key
measuring point (MP)
H height of the reduced front aperture (y) 11,0 cm
H’ centre line (H / 2) 5,5 cm
measuring points along the centre line
S – S  180,0 cm
MP’s exact = (Distance S-S) / (Max distance between readings) 9,0
rounded up = (Exact no. of MP's) rounded up 9
X distance between MP's = (Distance s-s) / (MP's Round up) 20,0 cm
X’ first and last MP (from Side walls) = X / 2 10 cm
Figure 4 — Grid for inflow velocity test – reduced front aperture - example
6.3.2.3.4 Calculation of result
When a flow volume is measured, calculate the inflow velocity (m/s) by dividing the average air volume
rate by the normal working aperture area using Formula (2)
q
v = (2)
ifl
A
N
where
is the average inflow velocity in m/s;
v
ifl
q
is the average air volume rate in m /s;

A 2
N is the normal working aperture area in m .
When a velocity with the reduced front aperture is measured, divide the area of the reduced front
aperture by the normal front aperture area and multiply by the average measured velocity using
Formula (3)
A
c
vv⋅ (3)
ifl c
A
N
where
=
v is the inflow velocity in m/s;
ifl
A 2
N is the normal front aperture area in m ;
A is the area of the reduced front aperture;
C
is the average measured velocity with reduced front aperture in m/s.
v
C
6.3.2.3.5 Expression of results
All individual measured values, a used correction factor given by the manufacturer (if used), the used
calculation and the result shall be reported.
6.3.2.3.6 Acceptance criteria
The average value for the inflow velocity shall be set according to the manufactures specified nominal set
point. The manufacturer should state the acceptance limits or the range (e.g. + or – value).
6.3.3 Alternative test methods
Test methods not described by the manufacturer may be used if a validated correlation with these test
methods has been demonstrated.
6.4 Visualization of airflows
6.4.1 General
Airflows around the installed BSC and in the front aperture should not be disturbed, e.g. by the room
make-up air, in a way that could negatively affect the performance of the BSC.
The visualization of the airflow shall be performed with generation of visible tracers, in front of the
working aperture.
6.4.2 Material and equipment
The aerosols for testing should be harmless to humans and to the environment (no sulphuric acid mist).
The density of the tracer shall be close to the room air density. The test shall be performed according to
the manufacturer’s specification.
6.4.3 Procedure
6.4.3.1 Downflow
6.4.3.1.1 Test procedure
Airflow within the working area of the cabinet shall be visualized at a height of 100 mm above the front
aperture
6.4.3.1.2 Acceptance criteria
The airflow should be directed downward at each point.
6.4.3.2 Inflow
6.4.3.2.1 Test procedure
The tracer shall be emitted at a distance of 5 cm in front of and over the entire front opening.
6.4.3.2.2 Acceptance criteria
The airflow around the front aperture shall be directed inward, without any reflux out of the cabinet or
penetration over the work surface.
6.4.3.3 Reflux
6.4.3.3.1 Test procedure
The tracer shall be released 15 cm below the downflow filter of the designated working area in a line
inside the designated working area with a distance of 5 cm behind the sash.
6.4.3.3.2 Acceptance criteria
The test should indicate airflow is even and downward.
6.4.4 Documentation
The observations should be documented.
7 Protective functions
7.1 General
A BSC class II shall provide operator, product and cross-contamination protection.
Appropriate procedures for testing the protective functions are described in the Annex A, Annex B and
Annex C. Any other test methods may be used provided a validated correlation is established with this
test method.
7.2 Operator protection
7.2.1 General
To ensure operator protection in a Biological Safety Cabinet (BSC), it is crucial to prevent the transfer of
hazardous or potentially hazardous biological agents from the inner space of the BSC to the outside. This
can be achieved through the following measures:
— stable and Effective Airflows: The airflow within the BSC shall be controlled to ensure that
contaminants are contained and directed appropriately. Downflow velocity and inflow velocity shall
be balanced correctly to ensure a stable airflow barrier at the front aperture of the BSC.
— HEPA Filtration of the Exhaust Air: High-Efficiency Particulate Air (HEPA) filters should be used to
filter the exhaust air, removing biological agents from the air before it is released outside the BSC.
— defined Leak Tightness of the Carcass: The structure of the BSC should be leak-tight, ensuri
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