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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 requirements Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standar
4、ds Board and comes into effect on 15 August 1998 BSI 1998 ISBN 0 580 30066 8 BS EN 12128:1998 Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 12128:1998. The UK participation in its preparation was entrusted
5、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 interpretation, or proposals for change, and keep the UK interests informed; monitor related international and Europ
6、ean developments and promulgate them in the UK. A list of organizations represented on this committee can 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 Standa
7、rds 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 contract. Users of British Standards are responsible for th
8、eir 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 12, an inside back cover and a back cover. Licensed Copy: sheffieldun sh
9、effieldun, na, Sat Oct 28 05:24:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and b
10、y any means reserved worldwide for CEN national Members. Ref. No. EN 12128:1998 E EUROPEAN STANDARDEN 12128 NORME EUROPE ENNE EUROPA ISCHE NORM March 1998 ICS 07.080; 07.100.01 Descriptors: Biotechnology, biology, microbiological analysis, laboratories, research, micro-organisms, safety, accident pr
11、evention, level: quality, hazards, specifications, classifications English version Biotechnology Laboratories for research, development and analysis Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements Biotechnologie Laboratoires de recherche, d
12、e 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 Analyse Sicherheitsstufen mikrobiologischer Laboratorien, Gefahrenbereich, Ra umlichkeiten und
13、 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 giving this European Standard the status of a national standard without any alteration. Up
14、-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 versions (English, French, German). A version in any other language made by translation und
15、er 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, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lux
16、embourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12128:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN
17、/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 September 1998, and conflicting national standards shall be withdrawn at the late
18、st by September 1998. 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, Ne
19、therlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Physical containment level classification4 5Physical containment level 1 laboratory (PCL1)4 6Physical containment level 2 laboratory (PC
20、L2)6 7Physical containment level 3 laboratory (PCL3)7 8Physical containment level 4 laboratory (PCL4)8 Annex A (informative) Guidance on space needs and dimensions10 Annex B (informative) Method of test for the determination of pressure differences11 Annex C (informative) Bibliography12 Licensed Cop
21、y: sheffieldun sheffieldun, na, Sat Oct 28 05:24:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 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 microbiologic
22、al hazards to humans, animals, plants and the environment, which should be complied with as a prerequisite 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
23、handling of micro-organisms; hence they serve to protect people, animals, plants and the environment. The 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 o
24、r the environment. For micro-organisms which are primarily animal or plant pathogens which present minimal 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) un
25、der Council Directive 90/219/EEC (see annex C 1). The requirements need to be selected on the basis of risk 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
26、circumstances. 1 Scope This European Standard specifies minimum physical requirements for biological safety 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 conta
27、inment of micro-organisms which can present a risk to human health. It applies to microbiology laboratories where the handling of micro-organisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out. NOTESome aspects can also be applicable to laboratories spec
28、ializing in disciplines other than microbiology which deal with specimens or other material not intended 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 cont
29、ain them. They are applicable to premises where there is an intention to manipulate or propagate micro-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
30、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 amendment or revision. For undated references the latest edi
31、tion of the publication referred to applies. prEN 12347, Biotechnology Equipment Performance criteria for autoclaves. prEN 12469, Biotechnology Performance criteria for microbiological safety cabinets. prEN 12740, Biotechnology Laboratories for research, development and analysis Guidance for handlin
32、g, inactivating and testing of waste. EN 61010, Safety requirements for electrical equipment for measurement, 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
33、61010-2-042, Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of 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
34、medical materials and for laboratory processes. (IEC 1010-2-043:1997) ISO 3864, Safety colours and signs. 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 standar
35、d, the following definitions apply. 3.1 autoclave apparatus designed to make materials and/or equipment sterile by exposure to steam at a pressure above the atmospheric pressure 3.2 cell culture in-vitro growth of cells derived from multicellular organisms Licensed Copy: sheffieldun sheffieldun, na,
36、 Sat Oct 28 05:24:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 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 does not occur naturally by mating and/or natural recombination NOTEWithin the terms of th
37、is 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 ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 N
38、OTEHarm 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 ancillary rooms and with shared use of facilities. 3.6 laboratory unit separate building, or s
39、elf-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 NOTEA microbiology laboratory (or suite, or unit) may be divided so as to provide separate areas for p
40、articular 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 material EN 1619 NOTEFor the purposes of this standard, the term micro-organism covers the ter
41、m 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 infection, allergy or toxicity. 3.8 physical containment system for confining a micro-organism o
42、r 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 primary physical containment system of physical containment which limits the escape of a micro-
43、organism or organism into the working environment NOTEThis can involve the use of closed containers or appropriate equipment together with secure operating procedures. 3.11 risk probability of occurrence of a hazard causing harm and the degree of severity of the harm 3.12 secondary physical containm
44、ent system of physical containment which limits the escape of a micro-organism or organism into the environment or into other working areas NOTEThis can involve the use of rooms with specially designed air handling, the existence of airlocks and/or sterilizers for the removal of materials and secure
45、 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 to one of four basic physical containment levels. These levels are designated PCL1, indicating
46、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 1Generally the containment requirements of a higher level include those of the lower level(s). NOTE 2Micro-orga
47、nisms 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. 5 Physical containment level 1 laboratory (PCL1) 5.1 Location and physical provisions (PCL1) Mic
48、robiological work shall be carried out in laboratories specified for the purpose. NOTE 1It is recommended that the PCL1 status is clearly marked on the outside of the laboratory door. There shall be adequate space for each worker. NOTE 2Guidance on the space needs and dimensions is given in annex A.
49、 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 (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 1A method of test for the assessment of surface resistance to cold liquids is given in ISO 4211. The l
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