1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12128:1998 The Euro
2、pean Standard EN 12128:1998 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 Laboratories for research, development and analysis Containment levels of microbiology laboratories, areas of risk, localities a
3、nd physical safety requirementsThis British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 August 1998 BSI 1998 ISBN 0 580 30066 8 BS EN 12128:1998 Amendments iss
4、ued since publication Amd. No. Date Text affected National foreword This British Standard is the English language version of EN 12128:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand
5、 the text; present to the responsible European committee any enquiries on the interpretation, 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
6、be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “
7、Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from le
8、gal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 12, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat:
9、 rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12128:1998 E EUROPEAN STANDARD EN 12128 NORME EUROPE ENNE EUROPA ISCHE NORM March 1998 ICS 07.080; 07.100.01 Descriptors: Biotechnology, biol
10、ogy, microbiological analysis, laboratories, research, micro-organisms, safety, accident prevention, level: quality, hazards, specifications, classifications English version Biotechnology Laboratories for research, development and analysis Containment levels of microbiology laboratories, areas of ri
11、sk, localities and physical safety requirements Biotechnologie Laboratoires de recherche, de de veloppement et danalyse Niveaux de confinement des laboratoires de microbiologie, zones a risque, situations et exigences physiques de se curite Biotechnik Laboratorien fu r Forschung, Entwicklung und Ana
12、lyse Sicherheitsstufen mikrobiologischer Laboratorien, Gefahrenbereich, Ra umlichkeiten und technische Sicherheitsanforderungen This European Standard was approved by CEN on 28 February 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
13、 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 official
14、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 Austria, Belgi
15、um, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12128:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechn
16、ology, 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 September 1998, and conflicting national standards shall be withdrawn at the latest by September 1
17、998. According to the CEN/CENELEC 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, Ireland, Italy, Luxembourg, Netherlands, Norway
18、, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Physical containment level classification 4 5 Physical containment level 1 laboratory (PCL1) 4 6 Physical containment level 2 laboratory (PCL2)
19、6 7 Physical containment level 3 laboratory (PCL3) 7 8 Physical containment level 4 laboratory (PCL4) 8 Annex A (informative) Guidance on space needs and dimensions 10 Annex B (informative) Method of test for the determination of pressure differences 11 Annex C (informative) Bibliography 12Page 3 EN
20、 12128:1998 BSI 1998 Introduction This European Standard sets minimum physical containment requirements for biological safety based on the principles of the prevention and control of microbiological hazards to humans, animals, plants and the environment, which should be complied with as a prerequisi
21、te for the setting up and continued operation of a microbiology laboratory. Compliance with the physical safety requirements set out in this standard should minimize the risks associated with the handling of micro-organisms; hence they serve to protect people, animals, plants and the environment. Th
22、e physical containment level to be used is determined by risk assessment (see annex C 1, 2). The requirements laid down may act as primary or secondary containment measures to protect the worker or the environment. For micro-organisms which are primarily animal or plant pathogens which present minim
23、al or no risk to human health, differing primary and secondary containment measures may be applicable. There are special containment requirements for genetically modified micro-organisms (GMMs) under Council Directive 90/219/EEC (see annex C 1). The requirements need to be selected on the basis of r
24、isk assessment from the four reference physical containment levels described. Secondary containment measures, in addition to those given in this European Standard, can be required in some special circumstances. 1 Scope This European Standard specifies minimum physical requirements for biological saf
25、ety for laboratories at four reference physical containment levels which are appropriate for handling micro-organisms of different risk groups. This European Standard primarily addresses the containment of micro-organisms which can present a risk to human health. It applies to microbiology laborator
26、ies where the handling of micro-organisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out. NOTE Some aspects can also be applicable to laboratories specializing in disciplines other than microbiology which deal with specimens or other material not intende
27、d for cultivation but which may contain micro-organisms. The requirements given in this European Standard are to minimize risks that may result from handling micro-organisms or materials which contain them. They are applicable to premises where there is an intention to manipulate or propagate micro-
28、organisms of known or unknown identity. 2 Normative 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 hereafter. For dated refere
29、nces, 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. prEN 12347, Biotechnology Equipment Performance criteria f
30、or autoclaves. prEN 12469, Biotechnology Performance criteria for microbiological safety cabinets. prEN 12740, Biotechnology Laboratories for research, development and analysis Guidance for handling, inactivating and testing of waste. EN 61010, Safety requirements for electrical equipment for measur
31、ement, control and laboratory use. EN 61010-2-041, Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes. (IEC 1010-2-041:1996) EN 61010-2-042, Particular requirements for autoclaves and sterilizers using toxic gas for the treatment o
32、f medical materials, and for laboratory processes. (IEC 1010-2-042:1997) EN 61010-2-043, Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials and for laboratory processes. (IEC 1010-2-043:1997) ISO 3864, Safety colours and sign
33、s. ISO 7000, Graphical symbols for use on equipment Index and synopsis. ISO 8995, Principles of visual ergonomics The lighting of indoor work systems. 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 autoclave apparatus designed to make materials and/or equipment
34、 sterile by exposure to steam at a pressure above the atmospheric pressure 3.2 cell culture in-vitro growth of cells derived from multicellular organismsPage 4 EN 12128:1998 BSI 1998 3.3 genetically modified micro-organism micro-organism in which the genetic material has been altered in a way that d
35、oes not occur naturally by mating and/or natural recombination NOTE Within the terms of this definition genetic modification occurs at least through the use of the techniques listed in the Directive 90/219/EEC or its appropriate annexes (see annex C 1). 3.4 hazard intrinsic potential property or abi
36、lity of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTE Harm is an injury or damage to health of people and/or the environment. 3.5 laboratory suite one or more laboratories within a building, not necessarily of the same discipline or containment level, with anc
37、illary rooms and with shared use of facilities. 3.6 laboratory unit separate building, or self-contained suite within a building, containing one or more laboratories and with ancillary rooms such as airlocks, changing rooms, showers, preparation rooms, sterilizer rooms, and storage rooms NOTE A micr
38、obiology laboratory (or suite, or unit) may be divided so as to provide separate areas for particular purposes, e.g. for media and reagent preparation, sterilization, microscopy. 3.7 micro-organism microbiological entity, cellular or non cellular, capable of replication or of transferring genetic ma
39、terial EN 1619 NOTE For the purposes of this standard, the term micro-organism covers the term of biological agent, according to the Directive 90/679/EEC: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites which may be able to provoke any inf
40、ection, allergy or toxicity. 3.8 physical containment system for confining a micro-organism or organism or other entity within a defined space EN 1620 3.9 physical containment level standard of accommodation suitable for the containment of micro-organisms according to the hazard they present 3.10 pr
41、imary physical containment system of physical containment which limits the escape of a micro-organism or organism into the working environment NOTE This can involve the use of closed containers or appropriate equipment together with secure operating procedures. 3.11 risk probability of occurrence of
42、 a hazard causing harm and the degree of severity of the harm 3.12 secondary physical containment system of physical containment which limits the escape of a micro-organism or organism into the environment or into other working areas NOTE This can involve the use of rooms with specially designed air
43、 handling, the existence of airlocks and/or sterilizers for the removal of materials and secure operating procedures. In many cases it can add to the effectiveness of primary physical containment. 4 Physical containment level classification A microbiology laboratory shall be classified as belonging
44、to one of four basic physical containment levels. These levels are designated PCL1, indicating the lowest, to PCL4, indicating the highest level of containment. The requirements for each physical containment level are given in clause 5 to clause 8 and are summarized in Table 1. NOTE 1 Generally the
45、containment requirements of a higher level include those of the lower level(s). NOTE 2 Micro-organisms are allocated into risk groups on the basis of their potential to cause harm. Micro-organisms shall be handled in the appropriate laboratory containment level as indicated by an assessment of risk.
46、 5 Physical containment level 1 laboratory (PCL1) 5.1 Location and physical provisions (PCL1) Microbiological work shall be carried out in laboratories specified for the purpose. NOTE 1 It is recommended that the PCL1 status is clearly marked on the outside of the laboratory door. There shall be ade
47、quate space for each worker. NOTE 2 Guidance on the space needs and dimensions is given in annex A. In determining the amount of space required consideration should be given to factors such as the intended nature of the work and space for bench-mounted and free-standing equipment. 5.2 Cleanability (
48、PCL1) Bench surfaces shall be impervious to water, shall be easy to clean and shall be resistant to disinfectants, cleaning agents, acids, alkalis, solvents and other chemicals which may be expected in normal use. NOTE 1 A method of test for the assessment of surface resistance to cold liquids is gi
49、ven in ISO 4211. The laboratory shall be designed to facilitate effective cleaning. NOTE 2 Surfaces should be accessible for maintenance.Page 5 EN 12128:1998 BSI 1998 Table 1 Summary of requirements for laboratories of physical containment levels 1 to 4 Requirements 1) Physical containment level 123 4 Containment level labelled Yes 2) Yes Yes Yes Hazard zones labelled with biohazard sign Yes Yes Yes Adequate space for each worker Yes Yes Yes Yes Laboratory rooms separated by doors No 3) Yes Yes (lockable)
