oSIST prEN 12469-2:2024
(Main)Biological safety cabinets - Part 2: BSC class II
Biological safety cabinets - Part 2: BSC class II
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 worker, the environment and product protection including cross-contamination.
Biologische Sicherheitswerkbänke - Teil 2: BSC Klasse II
Dieses Dokument legt die spezifischen Anforderungen an BSW Klasse II in Bezug auf Konstruktion, Auslegung, Sicherheit und Hygiene fest.
Es legt die spezifischen Leistungskriterien für BSW Klasse II für die Arbeit mit biologischen Arbeitsstoffen sowie Prüfverfahren in Bezug auf den Schutz des Personals, den Schutz der Umgebung und den Produktschutz, einschließlich Kreuzkontamination, fest.
Postes de sécurité biologique - Partie 2: BSC de type II
Le présent document spécifie les exigences spécifiques aux BSC de type II en ce qui concerne la conception, la construction, la sécurité et la santé.
Il définit les critères de performance spécifiques des BSC de type II pour le travail avec des agents biologiques et spécifie les procédures d'essai en matière de protection de l'opérateur, de l'environnement et du produit, y compris la contamination croisée.
Biološke varnostne omare - 2. del: BSC razred II
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Biološke varnostne omare - 2. del: BSC razred 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: prEN 12469-2
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 2: BSC class II
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 12469-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
5.1 General. 7
5.2 Stability . 7
5.3 Ergonomics . 7
5.4 Lighting . 7
5.5 UV lamps . 7
5.6 Sound and vibrations. 7
5.7 Glazing . 7
5.8 Carcass . 7
5.9 Filter system . 9
5.10 Alarm indicators and alarms . 9
5.11 Gas supply . 9
5.12 Electrical installation . 9
5.13 Stop / start of BSC . 9
5.14 Connection to exhaust systems . 9
5.15 Cleanability . 9
5.16 Decontaminability . 10
5.17 Intake grille . 10
5.18 Height of the front aperture . 10
6.1 General. 10
6.2 Downflow . 10
6.3 Inflow . 12
6.4 Disturbance of airflows . 15
7.1 General. 16
7.2 Operator protection . 16
7.3 Product protection . 17
7.4 Cross-contamination protection . 17
7.5 Stability of the protective functions . 17
8.1 Operating manual . 17
8.2 Equipment logbook . 17
8.3 Brief instructions for use . 18
Annex A (normative) Test for operator protection . 19
Annex B (normative) Test for product protection . 31
Annex C (normative) Test for cross-contamination protection . 34
Annex D (normative) Test of the stability of protective functions . 37
Bibliography . 39
European foreword
This document (prEN 12469-2:2024) 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 12469-3:202X, prEN 12469-4:202X and
prEN 12469-5:2024, will partially supersede EN 12469:2000.
— the structure has been changed to emphasize different classes of biological safety cabinets (BSC);
— additional test t of the stability of protective functions;
— the text of the entire document has been revised and references have been updated.
prEN 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
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 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 worker, 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.
prEN 12469-1, 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 prEN 12469-1 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
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
5.5 UV lamps X
5.6 Sound and vibration X
5.7 Glazing X
5.8 Carcass X
X
5.9 Filter System X X X
5.10 Alarm Indicators and alarms
5.10.1 Alarm indicators X
X
5.10.2 Alarms X X X
R
5.11 Gas supply X R X
X
5.12 Electrical installation X X X
X
5.13 Stop/start of BSC X X X
X
5.14 Connection to exhaust system X
5.15 Cleanability X
5.16 Decontaminability X
5.17 Spillage tray X
5.18 Intake grille X
6 Airflows
X
6.2 Downflow X X X
X
6.3 Inflow X X X
X
6.4 Disturbance of airflows X X
7 Protective functions
a X
X X
7.2 Operator protection
7.3 Product protection X
7.4 Cross-contamination protection X
7.5 Stability of the protective functions X
b
8 Accompanying documents
X
8.1 Operating manual X X X
X
8.2 Equipment logbook X X X
X
8.3 Brief instruction for use X X X
X
9 Marking X X X
a
A1 for type test, A2 for commissioning and routine test
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 prEN 12469-1.
5.2 Stability
The stability shall be in accordance with prEN 12469-1.
5.3 Ergonomics
The ergonomics shall be in accordance with prEN 12469-1.
5.4 Lighting
5.4.1 General
The lighting shall be in accordance with prEN 12469-1.
5.4.2 Testing
The lighting shall be tested according to prEN 12469-1.
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. Start
...
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