oSIST prEN 12469-1:2024
(Main)Biological safety cabinets - Part 1: Classes and basic requirements
Biological safety cabinets - Part 1: Classes and basic requirements
This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of prEN 12469.
Biologische Sicherheitswerkbänke - Teil 1: Klassen und grundlegende Anforderungen
Dieses Dokument legt die Mindestanforderungen an BSW in Bezug auf Konstruktion, Auslegung, Sicherheit und Hygiene fest und gibt allgemeine Prüfverfahren für deren Verifizierung an.
Die Anforderungen für die verschiedenen Klassen sind in den entsprechenden Teilen von prEN 12469 aufgeführt.
Postes de sécurité biologique - Partie 1: Types et exigences fondamentales
Le présent document spécifie les exigences minimales applicables aux BSC en matière de conception, de construction, de sécurité et d'hygiène, et fournit des méthodes d'essai générales pour leur vérification.
Les exigences applicables aux différents types sont fournies dans les parties correspondantes du prEN 12469.
Biološke varnostne omare - 1. del: Razredi in osnovne zahteve
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Biološke varnostne omare - 1. del: Razredi in osnovne zahteve
Biological safety cabinets - Part 1: Classes and basic requirements
Biologische Sicherheitswerkbänke - Teil 1: Klassen und grundlegende Anforderungen
Postes de sécurité biologique - Partie 1: Types et exigences fondamentales
Ta slovenski standard je istoveten z: prEN 12469-1
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 1: Classes and basic
requirements
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 12469-1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 BSC classes . 9
4.1 Overview . 9
4.2 BSC class I . 10
4.3 BSC class II . 10
4.4 BSC class III. 10
5 Tests . 10
5.1 General. 10
5.2 Type test . 10
5.3 Factory test . 11
5.4 Commissioning . 11
5.5 Routine test . 11
6 Design and construction . 11
6.1 General. 11
6.2 Stability . 11
6.3 Ergonomics . 11
6.4 Lighting . 12
6.4.1 General. 12
6.4.2 Testing . 12
6.5 UV lamps . 13
6.6 Sound and vibrations. 13
6.6.1 General. 13
6.6.2 Testing . 13
6.7 Glazing . 14
6.7.1 Material . 14
6.7.2 Construction . 14
6.8 Carcass . 14
6.9 Filter system . 14
6.9.1 General. 14
6.9.2 Testing . 15
6.10 Alarms and alarm indicators . 16
6.10.1 Alarm indicators . 16
6.10.2 Alarms . 17
6.10.3 Testing of the requirements on audible and visual alarm indicators . 17
6.10.4 Testing of function of alarm indicators. 17
6.11 Gas supply . 17
6.12 Electrical installation . 17
6.13 Stop / start of BSC . 17
6.14 Connection to exhaust systems . 17
6.15 Cleanability . 18
6.15.1 General . 18
6.15.2 Testing . 18
6.16 Decontaminability . 18
6.16.1 General . 18
6.17 Spillage tray . 19
7 Airflows . 19
8 Accompanying documents . 19
8.1 Operating manual . 19
8.1.1 General information . 19
8.1.2 Procedures for cleaning and decontamination . 20
8.2 Equipment logbook . 20
8.3 Brief instructions for use . 20
9 Marking – ID plate . 20
Annex A (normative) Test room requirements . 21
Bibliography . 23
European foreword
This document (prEN 12469-1:2024) 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 12469-2:2024, 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);
— 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.
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