1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12469:2000 The Euro
2、pean Standard EN 12469:2000 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for microbiological safety cabinetsThis British Standard, having been prepared under the direction of the S
3、ector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 July 2000 BSI 07-2000 ISBN 0 580 34869 5 BS EN 12469:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the of
4、ficial English language version of EN 12469:2000. It supersedes Parts 1 and 3 of the 1992 edition of BS 5726, which relate to the specification, performance and testing of microbiological safety cabinets. The remaining parts of BS 5726 are being revised to give guidance on the selection, installatio
5、n and maintenance of microbiological safety cabinets. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpre
6、tation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. EN 12469 was developed by CEN/TC 233 Biotechn
7、ology in support of 90/219/EEC Council Directive of 23 April 1990 on the contained use of genetically modified organisms, and 90/679/EEC Council Directive of 29 November 1990 on the protection of workers from the risks related to exposure to biological agents at work. It applies to microbiological s
8、afety cabinets used for other purposes, including containment of biological agents and infected animals. Note Directive 90/219/EEC was amended by 98/81/EC Council Directive of 26 October 1998 on community classification of biological agents. BS EN 12469 differs from the 1992 edition of BS 5726 in th
9、e following aspects. The mandatory part of the standard includes a type test for operator protection. However, this is only optional at installation and is not specifically required at routine maintenance. Some other important items which were mandatory in BS 5726, such as airflows and dimensions, a
10、re included in EN 12469 only as informative annexes. The option of potassium iodide or bacterial challenge testing for operator protection remain, but the methods for bacterial testing have been brought into line with those specified by the National Sanitation Foundation (USA) in NAF 49 for Class II
11、 microbiological safety cabinets, and the results are expressed in absolute values rather than as a ratio. Requirements for installation and commissioning remain open. The Control of Substances Hazardous to Health (COSHH) 1999 regulations give requirements for performance of risk assessments for mai
12、ntenance and control of microbiological safety cabinets and purchasers and users are advised to consult the HSE/C guidance notes including that produced by the Advisory Committee on Dangerous Pathogens. Cross-references The British Standards which implement international or European publications ref
13、erred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a
14、 contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 45 and a bac
15、k cover. The BSI copyright notice displayed in this document indicates when the document was last issued.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12469 May 2000 ICS 07.080; 07.100.01 English version Biotechnology - Performance criteria for microbiological safety cabinets Biotechnologie -
16、 Critres de performance pour les postes de scurit microbiologique Biotechnik - Leistungskriterien fr mikrobiologische Sicherheitswerkbnke This European Standard was approved by CEN on 3 January 2000. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condit
17、ions 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 Central Secretariat or to any CEN member. This European Standard exists in three o
18、fficial 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austri
19、a, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secre
20、tariat: rue de Stassart, 36 B-1050 Brussels 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12469:2000 EPage 2 EN 12469:2000 BSI 07-2000 Contents Page Foreword 3 Introduction4 1 Scope.4 2 Normative references .4 3 Definitions
21、.5 4 Hazards6 5 Performance classes 6 7 Safety requirements12 8 Marking and packaging 13 9 Documentation14 Annex A (informative) Guidance on materials, design and manufacture .15 Annex B (normative) Test method for leakage of carcass for class I and II MSCs 18 Annex C (normative) Test methods for th
22、e retention efficiency at the front aperture 19 Annex D (informative) Aerosol challenge test method for installed HEPA filter system leakage detection30 Annex E (normative) Test method for product protection for class II MSCs32 Annex F (normative) Test method for cross contamination protection for c
23、lass II MSCs.34 Annex G (informative) Method of measurement of volumetric airflow rate .36 Annex H (informative) Design of MSCs and airflow velocities in MSCs .38 Annex J (informative) Recommendations for decontamination, cleaning and fumigation of MSCs and filters .40 Annex K (informative) Recommen
24、dations for routine maintenance of MSCs42 Bibliography.44Page 3 EN 12469:2000 BSI 07-2000 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233 “Biotechnology“, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national sta
25、ndard, either by publication of an identical text or by endorsement, at the latest by November 2000, and conflicting national standards shall be withdrawn at the latest by November 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countrie
26、s are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.Page 4 EN 12469:2000 BSI 07-2000 Introduction Microbiolo
27、gical safety cabinets are intended to reduce the risk to the operator when handling hazardous or potentially hazardous micro-organisms. They do not necessarily protect the operator from all hazards involved. Some types of safety cabinet can also protect the materials being handled in them from envir
28、onmental contamination. 1 Scope This 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 micro-organisms and specifies test procedu
29、res for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross contamination. Mechanical, electrical, chemical or radioactive safety precautions are not covered in the standard but are covered in EN 61010-1, EN 292-1 and EN 292-2 (s
30、ee Bibliography 1, 2 and 3). This European Standard does not cover safety precautions for aspects not associated with the use of micro-organisms such as those covering mechanical and electrical hazards, which are covered in EN 61010-1 (see Bibliography 1), nor does it cover safety requirements regar
31、ding flammable gas and inert gases. NOTE Some features of MSCs in addition to those for performance and safety are given for guidance in this European Standard and in EN 12741 (see Bibliography 4). 2 Normative references This European Standard incorporates by dated or undated reference, provisions f
32、rom other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amend
33、ment or revision. For undated references the latest edition of the publication referred to applies. EN 1822-1 High efficiency air filters (HEPA and ULPA) - Part 1: Classification, performance testing, marking EN 12296 Biotechnology - Equipment - Guidance on testing procedures for cleanability EN 122
34、97 Biotechnology - Equipment - Guidance on testing procedures for sterilizability EN 12298 Biotechnology - Equipment - Guidance on testing procedures for leaktightness EN 13091:1999 Biotechnology - Performance criteria for filter elements and filtration assembliesPage 5 EN 12469:2000 BSI 07-2000 3 D
35、efinitions For the purposes of this standard, the following definitions apply: 3.1 aperture protection factor (A pf ) Ratio of exposure to airborne contamination generated on the open bench, to the exposure resulting from the same dispersal of airborne contamination generated within the cabinet. 3.2
36、 cross contamination Unintended introduction of impurities of a chemical or microbiological nature from a material or product into another material or product. 3.3 microbiological safety cabinet (MSC) Ventilated enclosure intended to offer protection to the user and the environment from the aerosols
37、 arising from the handling of potentially hazardous and hazardous micro-organisms, with air discharged to the atmosphere being filtered. 3.4 MSC class I Safety cabinet with a front aperture through which the operator can carry out manipulations inside the cabinet and which is constructed so that the
38、 worker is protected and the escape of airborne particulate contamination generated within the cabinet is controlled by means of an inward airflow through the working front aperture and filtration of the exhaust air. 3.5 MSC class II Safety cabinet with a front aperture through which the operator ca
39、n carry out manipulations inside the cabinet and which is constructed so that the worker is protected, the risk of product and cross contamination is low and the escape of airborne particulate contamination generated within the cabinet is controlled by means of an appropriate filtered internal airfl
40、ow and filtration of the exhaust air. NOTE A typical way of achieving this is by means of a uni-directional downward laminar airflow inside the cabinet and an air-curtain at the front aperture. 3.6 MSC class III Safety cabinet in which the working area is totally enclosed and the operator is separat
41、ed from the work by a physical barrier (i.e. gloves mechanically attached to the cabinet). Filtered air is continuously supplied to the cabinet and the exhaust air is treated to prevent release of micro-organisms. NOTE 1 Relevant provisions of this standard for class III microbiological safety cabin
42、ets may apply in respect of performance and construction to rigid or flexible film isolators. Further guidance specific to isolators is given in EN 12741 (see Bibliography 4).Page 6 EN 12469:2000 BSI 07-2000 NOTE 2 The exhaust air can be cleaned by at least double in-line high efficiency particulate
43、 air filters and can be conducted through its own exhaust air system into the open air. 3.7 product protection Ability of the MSC to prevent airborne contamination from outside entering the MSC through the front aperture. 3.8 retention efficiency Ability of barrier to retain micro-organisms and/or a
44、erosols measured as the ratio of the concentration of a given marker substance between a challenged area and an adjacent area. NOTE For MSCs, the protection of operators, environment and products is achieved by various barriers such as housing, filters or adequate flow patterns. The function of thos
45、e barriers is to prevent or minimize the transfer of micro-organisms/aerosols between adjacent areas being separated by a barrier. Depending on the direction of the transfer to be considered, the challenge area can be the cabinet working space, the upstream side of filters or the laboratory environm
46、ent. 3.9 working space Part of the interior of the cabinet within which manipulations are carried out. 4 Hazards The following hazards shall be taken into account: - release of micro-organisms during operation for example through the front aperture, exhaust, piping or carcass; - release of micro-org
47、anisms during dismantling or maintenance e.g. filter replacement of MSCs or parts thereof following improper sterilization; - release of micro-organisms by removal of contaminated material from the MSC after product- or cross contamination. 5 Performance classes 5.1 Leaktightness The performance cla
48、sses for leaktightness of MSCs are given in table 1.Page 7 EN 12469:2000 BSI 07-2000 Table 1 - Leaktightness performance Performance class for leaktightness Leaktightness Index (LI) Description of performance class LI-A leakage of target micro-organism not defined LI-B leakage 1)of target micro-orga
49、nism detected and quantified under defined conditions LI-C leakage 1)of target micro-organism tested under defined conditions and leakage below detection limit or threshold value 2) 1) Based on leakage assessment by BATNEEC (Best Available Technique Not Entailing Excessive Costs) * . 2) Prescribed threshold value should be based on the required safety level and can for example be the detection limit of an approved BATNEEC. 5.2 Cleanability The performance classes for cleanability of MSCs are given in table 2. Table 2 - Cleanability perform
