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1、BRITISH STANDARD BS 5726-1: 1992 Microbiological safety cabinets Part 1: Specification for design, construction and performance prior to installation Licensed Copy: sheffieldun sheffieldun, na, Mon Dec 04 15:54:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5726-1:1992 This British Standard, havin
2、g been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 June 1992 BSI 12-1998 The following BSI references relate to the work on this standard: Committee reference HCC/28 Draft for comment
3、 91/52389 DC ISBN 0 580 20748 X Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/28, upon which the following bodies were represented: Association of the British Ph
4、armaceutical Industry Association of Clinical Pathologists Association of Medical Microbiologists British Health and Safety Society British Laboratory Ware Association British Occupational Hygiene Society Chartered Institution of Building Services Engineers Department of Health Guild of Hospital Pha
5、rmacists Health and Safety Executive Institute of Animal Health Institute of Biology Institute of Hospital Engineering Institute of Medical Laboratory Sciences Institution of Mechanical Engineers Manufacturing Science Finance Medical Research Council Ministry of Agriculture, Fisheries and Food Publi
6、c Health Laboratory Service Royal College of Pathologists Coopted members Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Mon Dec 04 15:54:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5726-1:1992 BSI 12-1998i Contents Page Committees responsib
7、leInside front cover Forewordii 1Scope1 2Definitions1 3Materials and components of construction1 4Stability2 5Resistance to vibration3 6Electrical equipment3 7Gas fittings3 8Filters, gaskets and cases3 9Exhaust fan and effluent air4 10Noise level4 11Alarms and indicators4 12Performance4 13Particular
8、 requirements for Class I cabinets5 14Particular requirements for class II cabinets5 15Particular requirements for class III cabinets5 16Documentation, information and marking6 Appendix A Method of test for chemical resistance7 Appendix B Method of testing for leakage through filters, seals and cons
9、truction joints7 Appendix C Method of test for vibration resistance7 Appendix D Determination of the protection factor for class I and class II cabinets8 Appendix E Method for external contamination tests12 Appendix F Method of test for cross contamination12 Appendix G Method of testing for leakage
10、of cabinet carcass13 Appendix H Method for air velocity measurement13 Appendix J Bibliography14 Figure 1 Method of mounting filters4 Publication(s) referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Mon Dec 04 15:54:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5726-1:1992 i
11、i BSI 12-1998 Foreword This Part of BS 5726 was prepared under the direction of the Health Care Standards Policy Committee. Together with Parts 2, 3 and 4 it supersedes BS 5726:1979, which is withdrawn. Microbiological safety cabinets are also known as biological safety cabinets. The differences bet
12、ween this Part of BS 5726 and the 1979 edition include the following. a) Requirements are specified in terms of performance tests which have been written to relate as far as possible to standards in force in other countries. b) Design is specified in terms of performance so that the standard is less
13、 restrictive e.g. cabinet length is no longer specified. c) The centrally important operator protection test has been modified to include sampling at the lower edge of the front window. The Parts of this standard are as follows: Part 1: Specification for design, construction and performance prior to
14、 installation. This Part is aimed primarily at manufacturers; Part 2: Recommendations for information to be exchanged between purchaser, vendor and installer and recommendations for installation. This Part is aimed primarily at installers; Part 3: Specification for performance after installation. Th
15、is Part is aimed primarily at those commissioning the cabinets; Part 4: Recommendations for selection, use and maintenance. This Part replaces the notes for users given in appendix G of the previous edition. Appendix D gives three methods for determination of the operator protection factor for class
16、 I and class II cabinets. If asymmetry of the operator protection factor is to be determined only the microbiological method using slit samplers or the potassium iodide method are suitable. A British Standard does not purport to include all the necessary provisions of a contract. Users of British St
17、andards 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, pages i and ii, pages 1 to 14, an inside back cover and a back cover. Th
18、is standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Mon Dec 04 15:54:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5726-1:1992 BSI 12-19981
19、1 Scope This Part of BS 5726 specifies requirements for the design, construction and performance prior to installation for class I, class II and class III microbiological safety cabinets (also known as biological safety cabinets) together with class III cabinets which can subsequently be converted t
20、o class I cabinets. BS 5726 does not specify all requirements for safety cabinets intended for uses other than microbiological use. The principles involved and the methods of test described have wide application but where cabinets are constructed for special purposes, the onus of establishing their
21、effectiveness rests with users. Special safety cabinets for biotechnology or for handling, for example, cytotoxic or radiopharmaceutical material are not covered by this standard but some of the requirements for filters and containment performance specified in this standard may be applicable. NOTE 1
22、The titles of the standards publications referred to in this standard are listed on the inside back cover. NOTE 2Bibliographical references are listed in appendix J. 2 Definitions For the purposes of this Part of BS 5726 the following definitions apply. 2.1 microbiological safety cabinet cabinet int
23、ended to offer protection to the user and environment from the aerosol hazards of handling infected and other hazardous biological material, but excluding radioactive, toxic and corrosive substances, with air discharged to the atmosphere being filtered NOTEMicrobiological safety cabinets are intende
24、d to reduce the risk to the operator when handling hazardous biological materials but do not necessarily protect the operator from all the hazards involved. Some types of cabinet may also protect the materials being handled in them from environmental contamination. 2.2 class I microbiological safety
25、 cabinet safety cabinet with an opening through which the operator can carry out manipulations inside the cabinet and which is so constructed as to minimize, by means of an inward airflow through the working aperture, the escape of airborne particulate contamination generated within the cabinet 2.3
26、class II microbiological safety cabinet safety cabinet with an opening through which the operator can carry out manipulations inside the cabinet, in which the work space is flushed with a unidirectional (so-called laminar) filtered downward airflow and which is so constructed as to minimize, by mean
27、s of an inward airflow through the working aperture, the escape of airborne particulate contamination generated within the cabinet 2.4 class III microbiological safety cabinet safety cabinet in which the operator is separated from the work by a physical barrier, i.e. by gloves mechanically attached
28、to the cabinet, and into which filtered air is continuously supplied and from which the escape of any airborne particulate contamination is prevented by exhaust and inlet filtration systems 2.5 working space part of the interior of the cabinet within which manipulations may be safely carried out 2.6
29、 manufacturer organization that designs, constructs, supplies and usually tests the cabinet, in accordance with this standard NOTEBy agreement with the purchaser the tests may be carried out by a third party. 3 Materials and components of construction 3.1 General When the surfaces of all materials a
30、nd components are examined without magnification by normal or corrected vision, there shall be no cracks or surface defects including those leading to ineffective mating with gasket surfaces or other sealing devices. NOTEMaterials used in the construction of safety cabinets should withstand normal w
31、ear, and where appropriate corrosive gas, fume or vapour, be structurally sound and dimensionally stable. All surfaces should be impervious, smooth, abrasion and corrosion resistant and of material which resists crazing, cracking and chipping. 3.2 Materials of construction 3.2.1 All cabinet interior
32、 work surfaces, including the sub-floor assembly, where fitted, shall be made of corrosion resistant material. Licensed Copy: sheffieldun sheffieldun, na, Mon Dec 04 15:54:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5726-1:1992 2 BSI 12-1998 3.2.2 If carbon steel sheet is used it shall be prime
33、 grade stretcher or roller levelled, complying with BS EN 10130 and with tolerances complying with BS EN 10131. 3.2.3 The finish of all interior work surfaces shall be uniform. NOTEConcealed surfaces or hollow metal sections should be protected by the finish applied after welding and before assembly
34、. 3.3 Chemical resistance When all cabinet internal work surfaces are tested in accordance with appendix A, and examined without magnification by normal or corrected vision there shall be no visible effect on the finish other than a slight change of gloss or discolouration compared with an untreated
35、 area. 3.4 Sealants for joints Sealants for joints shall be either: a) two-part accelerated synthetic rubber (polysulphide type) temperature resistant high adhesion grade or equivalent used in accordance with the manufacturers recommendations; or b) one-part silicone based sealant compound complying
36、 with BS 5889, and used in accordance with the manufacturers recommendations. 3.5 Fans The index of protection as specified in BS 5490 shall be not less than IP 44. NOTEFans of any configuration may be used provided they enable the cabinet to comply with the performance requirements specified in thi
37、s Part of BS 5726. 3.6 Windows 3.6.1 General Windows shall be made of either safety glass or safety plastics. Light transmission of windows shall comply with BS AU 178a, and impact resistance shall comply with class A of BS 6206. NOTE 1Where glass windows are provided, manufacturers should note the
38、recommendations given in appendix A of BS 3193:1989. NOTE 2Manufacturers should note that it is important that safety glass and safety plastics have the durability to continue to perform satisfactorily for their expected life, taking into account the external and internal environments to which they
39、will be exposed and the method of glazing. 3.6.2 Front window It shall be possible to seal the front window. Means shall be provided to hold the front window open securely for loading equipment etc. before starting work. When closed, the size, position and angle of the window shall be such as to giv
40、e an unobstructed view into the working space when the operator is seated centrally at the cabinet. NOTEFor class I and class III cabinets, an angle between 55 and 75 to the horizontal has been found to be satisfactory. 3.6.3 Vertical sliding sash windows Vertical sliding sash windows, if provided,
41、shall be constructed such that the sash cannot fall and endanger the user if the suspending system were to fail. 3.7 Cabinet floor The base of the cabinet shall be flat and rigid. If the working space has a solid floor, this shall be liquid-tight with a raised edge at least 10 mm high all round. If
42、the floor is perforated, as in some class II cabinets, the sub-floor into which any spilt liquid may drain shall be liquid-tight with a raised edge at least 10 mm high all round. The perforated floor shall be removable to allow access to the sub-floor for cleaning. The floor and any structures expos
43、ed when the floor is removed shall be free from sharp edges. 3.8 Corners All corners and angles inside the cabinet working space and other normally accessible areas (e.g. during cleaning) shall be: a) free from cracks or crevices, when examined without magnification, by normal or corrected vision; a
44、nd b) radiussed to a minimum of 3 mm. 3.9 Sealable panels A front sealable panel and associated fastenings to cover the open aperture of class I and class II cabinets shall be provided. When tested in accordance with appendix B the concentration of oil aerosol determined from scans around the sealab
45、le panel shall not exceed 0.003 % of the challenge concentration at any position. A sealing panel for the inlet filter of class III cabinets shall be provided. NOTEThe panels should be made of rigid, non-flammable, corrosion resistant material and should be easily and quickly attachable and removabl
46、e, for example, by means of simple spring toggle or finger screw operation which should not be hazardous to the operator. If integral seals are provided they should be so constructed that there is no danger of their coming loose. 4 Stability 4.1 Resistance to overturning With the cabinet placed on a
47、 flat rigid surface, and the front bottom edge of the cabinet prevented from sliding, the rear bottom edge shall not lift off the floor or bench by more than 1.6 mm when a lateral force of 440 N is applied at the centre of the top edge. Licensed Copy: sheffieldun sheffieldun, na, Mon Dec 04 15:54:02
48、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5726-1:1992 BSI 12-19983 4.2 Resistance to distortion 4.2.1 The front top edge of the cabinet shall not move forward by more than 1.6 mm when a lateral force of 1 120 N is applied to the centre of the rear top edge. 4.2.2 The side top edge of the cabine
49、t shall not move by more than 1.6 mm when a lateral force of 1 120 N is applied to the centre of the opposite side top edge. 4.3 Resistance to deflection of the work surface The work surface shall not be permanently deflected after applying and immediately removing a test load of 23 kg at the centre of an area 25 cm 25 cm. 4.4 Resistance to tipping The rear bottom edge of the cabinet shall not lift off the floor or bench more than 1.6 mm when a test load of 114 kg is applied to the leading edge of the work surface. 5 Resistance to vibration When tested in accordan