EN 12469-2000 en Biotechnology - Performance Criteria for Microbiological Safety Cabinets《生物技术 微生物安全柜的性能》.pdf

1、 STDsBSI BS EN L2469-ENGL 2000 E Lb24bb9 ObL007 T74 I BRITISH STANDARD Biotechnology - Performance criteria for microbiological safety cabinets The European Standard EN 12469:2 has the status of a British Standard ICs 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMIITED BY COPYRIG

2、m LAW BS EN 12469:2000 STD.BSI BS EN L24b9-ENGL 2000 Lb24bb9 OBbLOOB 900 BS EN 124692000 National foreword This British Standad is the oBcial English language version of EN 12469:2000. It supersedes Paas 1 and 3 of the 1992 edition of BS 5726, which relate to the specification, performance and testi

3、ng of miabiological safety cabines. The remaining parts of BS 5726 are being revised to give guidance on the selection, installation and maintenance of microbiological safa cabinets. The UK participation in its preparation was entrusted to Technical Committee CW58, Biotechnology, which has the respo

4、nsibility ta - aid enquirers to understand the tee - present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK intee inform4 - monitor related intemational and European developments and promulgate them in the UK. A list of organizatio

5、ns represented on this committee can be obtained on request to its semtqv EN 12469 was developed by CE“C 233 Ebtechmbgg in support of 90/219/EEC Council Directive of 23 April 1990 on the contained use of genetidly modified organisms, and 90/679/EEC Council Directive of 29 November 1990 on the protec

6、tion of workers from the risks related to exposure to biological agents at work It applies to microbiological safety cabinets used for other purposes, including containment of biological agents and infected animals. Noie Direcve golzls/EEc was amended by MYeC Couneil Directive of 26 October i908 on

7、community dasication of biological agents. BS EN 12469 differs from the 1992 edition of BS 5726 in the following aspects -The mandatory part of the standad includes a type test for oprator pmtection. However, this is oniy optionai at instailation and is not specicaiiy niquimi at routine maintenance.

8、 - Some other important items which were mandatory in BS 5726, such as airflows and dimensions, are included in EN 12469 oniy as informative mexes. -The option of potassium iodide or bacterial challenge testing for operator pmtection remain, but the methods for bacterial testing have been brought in

9、to line with those specified by the National Sanitation Foundation (USA) in NAF 49 for Class II microbiological safety cabine and the results are expressed in absolute values rather than as a ratio. - Requirements for installation and commissioning remain open. The Conml of Substances Hazardow to He

10、alth (COGEM) 1999 regulations give requirements for perfonnance of risk assessments for maintenance and control of microbiological safety cabinets and purchasers and users are advised to consult the HSWC guidance notes including that produced by the Advisory Committee on Dangerous Pathogens. Cross-r

11、eferences The British Standards which implement intemationai or European publications referred to in this document may be found in the BSI Standards Caaiogue under the section entitled “Jntemationai Standards Correspondence Index“, or by using the “Find“ facility of the BSI Standards Electronic Cata

12、logue. A British standard does not purport to include all the necessary provisions of a contract Usem of Bntish Standards are responsiile for their correct application. Compiiance with a British Standard does not of itself confer immunity fkom legal obiigatlons. Summary of pages This document compri

13、ses a front cover, an inside hnt cover, the EN titie page, pages 2 to 45 and a back cover, The BSI copyright notice displayed in this document indicates when the document was last issued. This British standard, having been DRD- under the dinxiirn- of the sector Committee for Mat 07.100.01 English ve

14、rsion Bi o t e c h no I o g y - Perform an ce criteria for m i c ro b i o I og i ca I sa fe t y cabinets Biotechnologie - CritBres de performance pour les postes de scurit microbiologique Biotechnik - Leistungskriterien fr mikrobiologische Sicherheitswerkbnke This European Standard was approved by C

15、EN on 3 January 2000. CEN members are bound to cornpy with the CENKENELEC Intemal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibiiographicai references conwrning sich national standards m

16、ay be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three oficial versions (English, French, German). A version in any other language made by trnslation under the responsibility of a CEN member into its own language and notified to the Cent

17、ral Secretariat has the same status as he offcial versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Noway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

18、EUROPEAN COMMITIEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPAISCHES KOMITEE FOR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels Q 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12469:2000 E Pag

19、e 2 EN 12469:2000 Contents Page Foreword 3 Introduction 4 Scope . 4 Normative references 4 Definitions . 5 Hazards . 6 Performance classes 6 Safety requirements 12 Marking and packaging . 13 Documentation 14 Annex A (informative) Guidance on materials. design and manufacture 15 Annex B (normative) T

20、est method for leakage of carcass for class I and II MSCs . 18 Annex C (normative) Test methods for the retention efficiency at the front aperture 19 Annex D (informative) Aerosol challenge test method for installed HEPA filter system leakage detection 30 Annex E (normative) Test method for product

21、protection for class II MSCs . 32 Annex F (normative) Test method for cross contamination protection for class 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) Recomme

22、ndations for decontamination. cleaning and fumigation of MSCs and filters 40 Annex K (informative) Recommendations for routine maintenance of MSCs . 42 Bibliography . 44 Q BSI 07-2000 STDOBSI BS EN L24b9-ENGL 2000 lb24bb9 OBbLOLL 4T5 Page 3 EN 12469:2000 Foreword This European Standard has been prep

23、ared 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 standard, either by publication of an identical text or by endorsement, at the latest by November 2000, and conflicting national standards

24、 shall be withdrawn at the latest by November 2000. According to the CENICENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland,

25、Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Q BSI 07-2000 Page 4 EN 12469:2000 Introduction Microbiological safety cabinets are intended to reduce the risk to the operator when handling hazardous or potentially hazardous micro-organis

26、ms. 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 environmental contamination. I Scope This European Standard specifies basic requirements for microbiological safety cabinets (MSCs) with

27、respect to safety and hygiene. This European Standard sets the minimum performance criteria for safety cabinets for work with micro-organisms and specifies test procedures for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross c

28、ontamination. 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 (see Bibliography I, 2 and 3). This European Standard does not cover safety precautions for aspects not associated with the use of mic

29、ro-organisms such as those covering mechanical and electrical hazards, which are covered in EN 61 O1 0-1 (see Bibliography I), nor does it cover safety requirements regarding flammable gas and inert gases. NOTE Some features of MSCs in addition to those for performance and safety are given for guida

30、nce in this European Standard and in EN 12741 (see Bibliography 4). 2 Nonnative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed

31、 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 amendment or revision. For undated references the latest edition of the publication referred to applies. EN 1822-1 High efficiency air

32、filters (HEPA and ULPA) - Part 1: Classification, performance testing, marking EN 12296 Biotechnology - Equipment - Guidance on testing procedures for cleanability EN 12297 Biotechnology - Equipment - Guidance on testing procedures for sterilizability EN 12298 Biotechnology - Equipment - Guidance on

33、 testing procedures for leaktig htness EN I3091 : 1999 Biotechnology - Performance criteria for filter elements and filtration assemblies O BSt 07-2000 STD.BSI BS EN L24bT-ENGL 2000 Lb24bb OBbLOL3 270 9 Page 5 EN 12469:2000 3 Defini ti o ns For the purposes of this standard, the following definition

34、s apply: 3.1 aperture protection factor (Apf) 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 cross contamination Unintended introduction of impurities of a chemical

35、 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 arising from the handling of potentially hazardous and hazardous micro-

36、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 worker is protected and the escape of airborne particulate Contaminatio

37、n 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 can carry out manipulations inside the cabinet and which is constructed so

38、 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 airflow and filtration of the exhaust air. NOTE A typical way of achieving th

39、is is by means of a uni-directional downward laminar aiflow inside the cabinet and an air-curtain at the front aperture. 3.6 MSC class 111 Safety cabinet in which the working area is totally enclosed and the operator is separated from the work by a physical barrier (.e. gloves mechanically attached

40、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 cabinets may apply in respect of performance and construction to rigid or flexi

41、ble film isolators. Further guidance specific to isolators is given in EN 12741 (see Bibliography 41). Q BSI 07-2000 STD-BSI BS EN L24bY-ENGL 2000 Lb24bb9 nab1034 LO4 D Page 6 EN 12469:ZOOO NOTE 2 The exhaust air can be cleaned by at least double in-line high efficiency particulate air filters and c

42、an 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 aerosols measured a

43、s 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 those barriers is to p

44、revent or minimize the transfer of micro-organismdaerosols 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 environment. 3.9 working sp

45、ace 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-organisms during disma

46、ntling 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 classes for leaktightn

47、ess of MSCs are given in table 1. Q BSI 07-2000 STD=BSI BS EN 324b7-ENGL 2000 O 3b24bb7 0863035 040 Performance class for leaktig htness Page 7 EN 12469:2000 Description of performance class Table 1 - Leaktightness performance Leaktightness Index (LI) LI-A LI-B leakage of target micro-organism not d

48、efined leakage) of target micro-organism detected and LI-c quantified under defined conditions leakage) of target micro-organism tested under defined conditions and leakage below detection limit or threshold value2) 5.2 Cleanability Performance class for cleanability Cleanability Index (Ci) CI-A CI-

49、B CI-c The performance classes for cleanability of MSCs are given in table 2. Description of performance class visible soil or cleanliness not defined cleanability) tested and quantified under defined conditions or MSC designed with regard to specified technical criteria cleanability) tested and quantified under defined conditions and soil below detection limit or threshold value 2, Table 2 - Cleanability performance The performance for cleanability shall be CI-B or better for all classes of MSCs. Cleanability applies as a performance cr