oSIST prEN 12469-5:2024

SLOVENSKI STANDARD
01-september-2024
Biološke varnostne omare - 5. del: Vgradnja, prevzemni postopki in rutinsko
preskušanje
Biological safety cabinets - Part 5: Installation, commissioning and routine testing
Biologische Sicherheitswerkbänke - Teil 5: Aufstellung, Inbetriebnahme und Wartung
Postes de sécurité biologique - Partie 5: Installation, mise en service et essais de routine
Ta slovenski standard je istoveten z: prEN 12469-5
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.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2024
ICS 07.080; 07.100.01 Will supersede EN 12469:2000 (PART)
English Version
Biological safety cabinets - Part 5: Installation,
commissioning and routine testing
Biotechnologie - Critères de performance pour les Biotechnik - Leistungskriterien für mikrobiologische
postes de sécurité microbiologique Sicherheitswerkbänke
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 332.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 12469-5:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Installation of BSC . 6
4.1 General. 6
4.2 Information required for installation of BSC . 6
4.3 Recommendations for siting of BSC class I and class II . 7
4.3.1 General. 7
4.3.2 Impact of extract-, make-up and supply air systems . 7
4.3.3 Impact of other equipment . 7
4.3.4 Space requirements . 7
4.3.5 Recommendations for the number of persons working at a BSC at the same time . 11
5 Commissioning of BSC . 12
5.1 General. 12
5.2 General inspections. 12
6 Routine testing and maintenance of BSC . 12
6.1 General. 12
6.2 Decontamination and disinfection . 12
6.3 Biological safety cabinets temporarily out of commission . 12
7 Test reports . 13
7.1 Reports for commissioning . 13
7.2 Reports for routine testing . 13
7.3 Deviation . 14
Bibliography . 15
European foreword
This document (prEN 12469-5:2024) has been prepared by Technical Committee CEN/TC 332
“Laboratory Equipment”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document, together with prEN 12469-1:2024, prEN 12469-2:2024, prEN 12469-3:202X and
prEN 12469-4:202X, will partially supersede EN 12469:2000.
— the structure has been changed to emphasize different classes of biological safety cabinets (BSC);
— the text of the entire document has been revised and references have been updated.
prEN 12469:2024 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

Under preparation.
Under preparation.
Introduction
Biological safety cabinets (BSC) are designed to reduce the risk to the operator when using biological
materials. Dependent on type, they can protect the operator, the product, and the environment from
biological aerosols.
BSC class I and class II are ventilated enclosures with an open front aperture.
A BSC class III is a fully enclosed workspace with gloves attached to the front port normally with an
additional pass-through box attached.
A BSC class I provides operator and environment protection.
A BSC class II provides operator, product, and environment protection. In addition, it offers cross-
contamination protection.
A BSC class III provides operator, environment and product protection. It is normally used in high level
containment facilities for the highest risk group agents.
The type of BSC required is usually based on risk group, risk assessment and application.
This document describes the design and testing of these BSC for use in laboratories handling biological
agents.
This document is a product standard. Occupational health and safety assessments methods are not
included.
1 Scope
This document gives requirements and recommendations for installation, commissioning and routine
testing of BSC.
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.
prEN 12469-1, Biological safety cabinets - Part 1: Classes and basic requirements
CEN/TS 17441, Laboratory installations - Ventilation systems in laboratories
3 Terms and definitions
For the purposes of this document, the terms and definitions given in prEN 12469-1 and the following
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/
3.1
commissioning
process of ensuring that the BSC is installed and tested according to this document
3.2
corrective maintenance
maintenance carried out after fault recognition and intended to restore an item into a state in which it
can perform a required function
[SOURCE: EN 13306:2017, 7.9]
3.3
hard duct
connection between two air handling devices that does not have any open sections
3.4
installation
physical placement including connection of mechanical, electrical, and communication services within a
building
3.5
maintenance
combination of all technical, administrative and managerial actions during the life cycle of an item
intended to retain it in, or restore it to, a state in which it can perform the required function
Note 1 to entry: Technical maintenance actions include observation and analyses of the item state (e.g. inspection,
monitoring, testing, diagnosis, prognosis, etc.) and active maintenance actions (e.g. repair, refurbishment).
[SOURCE: EN 13306:2017, 2.1, modified, Notes 2 and 3 to entry removed]
3.6
preventive maintenance
maintenance carried out intended to assess and/or to mitigate degradation and reduce the probability of
failure of an item
[SOURCE: EN 13306:2017, 7.1]
3.7
routine testing
test protocols carried out at predetermined intervals, intended to confirm that the BSC is operating within
manufacturers specifications
3.8
thimble
duct connection device that provides an air break between two air handling devices that prevents adverse
pressure situations when either of the devices fail
4 Installation of BSC
4.1 General
This clause gives recommendations and guidance on the installation of BSC, including siting and
connection to and interfacing with building ventilation and utility services.
4.2 Information required for installation of BSC
The following minimum information should be available for the installation. It is recommended that a site
survey should be carried out covering the following topics:
— cabinet size, weight, type and model;
— services/utilities to be fitted;
— dimensional clearances required for access to the final location;
— the location of the laboratory and the intended siting of the safety cabinet within the laboratory;
— details of the laboratory which might adversely affect the performance of the cabinet (location of
doors, windows, other ventilated devices that may cause draughts, air handling and air conditioning
systems, other air handling devices as well as other devices that generate temperature changes in
the laboratory);
— environmental operating conditions shall be considered (i.e. humidity, temperature ranges, heat
loading etc.);
— when ducted, requirements of the extraction system, i.e.:
— details about the connection (typically size, locations, thimble, hard duct, variable air volume
(vav)/constant air volume (cav)/constant volume regulator (cvr));
— settings resulting in variable exhaust air flows;
— exhaust air volume of BSC;
— data exchange between BSC and building management system;
— anti blow back;
— manufacturer instructions on installation;
— any other specific requirement.
4.3 Recommendations for siting of BSC class I and class II
4.3.1 General
The protective function of a BSC relies on a controlled inflow of air through the front aperture. Localized
air turbulence, temperature fluctuation, room layout, and large objects can affect the airflow performance
of BSC.
As a preliminary to the installation of BSC in a laboratory, the site should be surveyed by the BSC
manufacturer/installer to assess environmental conditions and positions of the BSC.
The survey should include a review of the possible positions for the BSC in relation to laboratory doors
and windows, the main routes of foot traffic and potential objects that can have an effect on the
performance of the BSC. Objects such as other BSC, work benches, walls and columns should all be taken
into consideration. In addition, other laboratory equipment should also be assessed and considered.
4.3.2 Impact of extract-, make-up and supply air systems
The impact of room air supplies and extracts including air-conditioning uni
...