BS 5726-2005 Microbiological safety cabinets - Information to be supplied by the purchaser to the vendor and to the installer and siting and use of cabinets - Recommendations and g.pdf

1、BRITISH STANDARD BS 5726:2005 Microbiological safety cabinets Information to be supplied by the purchaser to the vendor and to the installer, and siting and use of cabinets Recommendations and guidance ICS 11.140 BS 5726:2005 This British Standard was published under the authority of the Standards P

2、olicy and Strategy Committee on 24 March 2005 BSI 24 March 2005 First published March 1979 Second edition, as BS 5726-2 and -4, June 1992 Third edition, as BS 5726, March 2005 The following BSI references relate to the work on this British Standard: Committee reference CH/101 Draft for comment 04/30

3、078820 DC ISBN 0 580 45590 4 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/101, Healthcare and medical equipment, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ir

4、eland Association of Clinical Pathologists British Interior Textiles Association Consumer Policy Committee of BSI Furniture Industry Research Association Guild of Healthcare Pharmacists Health and Safety Executive Hospital Infection Society Institute of Biomedical Science Institute of Healthcare Eng

5、ineering and Estate Management Institution of Mechanical Engineers Institution of Occupational Safety and Health Medical Sterile Products Association Medicines and Healthcare products Regulatory Agency Royal College of Pathologists Royal Pharmaceutical Society of Great Britain Society of Environment

6、al Engineers Amendments issued since publication Amd. No. Date CommentsBS 5726:2005 BSI 24 March 2005 i Contents Page Committees responsible Inside front cover Foreword ii 1S c o p e 1 2 Normative references 1 3T e r m s a n d d e f i n i t i o n s 1 4 Information to be supplied by the purchaser 1 5

7、 Recommendations for siting of cabinets 2 6 Make-up air systems 3 7 Selection of cabinets 8 8 Training of users 8 9U s e o f c a b i n e t s 8 Bibliography 9 Figure 1 Recommendations for minimum distances for avoiding disturbance to the safety cabinet and its operator 5 Figure 2 Recommendations for

8、minimum distances for avoiding disturbance to other personnel 6 Figure 3 Air make-up and room ventilation systems 7BS 5726:2005 ii BSI 24 March 2005 Foreword This British Standard has been prepared by Technical Committee CH/101. It supersedes BS 5726-2:1992 and BS 5726-4:1992, which are withdrawn. B

9、S 5726-1:1992 and BS 5726-3:1992 were superseded by BS EN 12469:2000 and were withdrawn in July 2000. This revision gives recommendations and guidance on the information to be supplied by the purchaser to the vendor and to the installer and recommendations on the siting and use of microbiological sa

10、fety cabinets specified in BS EN 12469. The Technical Committee identified the following differences, in what they considered to be important safety related areas, between BS EN 12469:2000 and BS 5726-1:1992 and BS 5726-3:1992. The mandatory part of the standard includes a type test for operator pro

11、tection. However, this is only optional at installation and is not specifically required at routine maintenance. Some other important items that were mandatory in BS 5726-1 and BS 5726-2, such as airflows and dimensions are included in BS EN 12469 only as informative annexes. The option of potassium

12、 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 microbiological safety cabinets, and the results are expressed in absolute

13、values rather than as a ratio. Requirements for installation and commissioning remain open. Attention is drawn to the Health and Safety Commission publication The management, design and operation of microbiological containment laboratories 1, which covers essential safety requirements for microbiolo

14、gical safety cabinets. It has been assumed in the drafting of this standard that the execution of its provisions will be entrusted to suitably qualified and experienced people, for whose use it has been produced. This publication does not purport to include all the necessary provisions of a contract

15、. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. In particular attention is drawn to the Control of Substances Hazardous to Health Regulations 2002 2, the Building Regulations 2000 3, the Building Stand

16、ards (Scotland) Regulations 1990 4 and the Building Regulations (Northern Ireland) 2000 5. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 9 and a back cover. The BSI copyright notice displayed in this document indicates when the document was

17、 last issued.BS 5726:2005 BSI 24 March 2005 1 1 Scope This British Standard gives recommendations and guidance on information to be supplied by the purchaser to the vendor and to the installer, on siting, and on use, for microbiological safety cabinets as specified in BS EN 12469. 2 Normative refere

18、nces The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. BS EN 12469:2000, Biotechnology Performance

19、criteria for microbiological safety cabinets. 3 Terms and definitions For the purposes of this British Standard the terms and definitions given in BS EN 12469:2000 apply. 4 Information to be supplied by the purchaser 4.1 General It is strongly recommended that for safety cabinets conforming to BS EN

20、 12469 the information given in 4.2 and 4.3 be supplied by the purchaser to the vendor and to the installer. 4.2 Information to be supplied by the purchaser to the vendor The following information should be supplied by the purchaser to the vendor: a) any specific requirements which are evident from

21、consideration by the purchaser of the guidance given in Clause 5 and Clause 6; b) cabinet size and/or vendors reference number; c) services to be fitted; d) dimensions available for access to the building. 4.3 Information to be supplied by the purchaser to the installer The following information sho

22、uld be supplied by the purchaser to the installer: NOTE 1 The installer may be the same party as the vendor. a) the following details of the siting of the safety cabinet(s): 1) details of the building in which the safety cabinet is to be installed which might adversely affect the performance of the

23、cabinet, the location of the laboratory and the intended siting of the safety cabinet(s) within the laboratory; 2) the locations of doors, windows, fume cupboards, other safety cabinets, other laboratory furniture, laboratory equipment that might generate draughts (e.g. large centrifuges), ventilati

24、on grills, and diffusers or other air moving equipment; 3) any features listed in item 2) which are planned but have not yet been installed; NOTE 2 A site survey might be appropriate. b) details of the intended method of supplying ventilation make-up air and of the existing room ventilation; c) the

25、environmental requirements of the laboratory including the following: 1) maximum overall noise levels in the laboratory, particularly if more than one cabinet is required either in the same room or other rooms in the same building; 2) effects of any other cabinets and/or extraction units, air condit

26、ioning and ventilation systems, and equipment (e.g. large centrifuges), that might generate draughts or contribute to adverse air movements; 3) room air volume flow rate and any pressure differences with respect to the outside atmosphere;BS 5726:2005 2 BSI 24 March 2005 d) the accommodation spaces,

27、routes available and any specific design requirements for the safety cabinet extraction system; e) the locations and details of any existing mechanical, electrical or other services to be utilized in connection with the complete safety cabinet installation; f) the following details of the safety cab

28、inet(s) required: 1) whether a facility to vary the set extraction volume flow rate is required and, if so, the range that is required; 2) whether the safety cabinet extraction system is to be for continuous or intermittent use. 5 Recommendations for siting of cabinets 5.1 As a preliminary to the in

29、stallation of safety cabinets in a laboratory, the site should be surveyed by the safety cabinet installer to assess environmental conditions and possible exhaust ductwork route(s). The survey should include a review of the possible positions for the safety cabinet(s) in relation to laboratory doors

30、 and windows, the main routes of foot traffic past the front and the effects of ventilation systems installed in the laboratory, particularly identifying any draughts or air circulations that are liable to interfere with cabinet performance, and confirming that there is an adequate air supply to the

31、 room (see Clause 6). It is important to ensure that exhaust air is not released to the outside near windows, doors or air intakes. For containment level 3 laboratories, where there are difficulties in exhausting cabinet air to the outside, specialist advice should be obtained. Depending on the outc

32、ome of the survey, modifications may be necessary to improve the environment before the contractor can install a safety cabinet so that it conforms to the performance requirements specified in BS EN 12469. 5.2 Operator protection offered by a safety cabinet can be adversely affected by poor siting o

33、f the unit. Strong air currents can disrupt the airflow in open fronted (class I and class II) cabinets, which can significantly reduce operator protection. It is important, therefore, to avoid siting a microbiological safety cabinet in a thoroughfare or in line with a doorway or openable window. 5.

34、3 Preliminary airflow visualization tests, for example with small smoke tubes, can help in the selection of the optimum position within a room. In difficult conditions, it can be helpful to install the cabinet on a temporary basis in the proposed position and carry out aperture retention tests befor

35、e making a final decision on the siting of the cabinet. 5.4 The siting of safety cabinets in laboratories should be considered at the initial stages of the planning of a new building or before modification of an existing building. If additional safety cabinets are required in an existing laboratory,

36、 the recommendations given in this clause also apply. The recommendations for siting of microbiological safety cabinets given here are intended to optimise the performance of the cabinets and improve safety through avoidance of disturbances to the cabinet, to its operator and to other personnel, and

37、 through avoidance of interference with escape routes, etc. It should be noted that it is not possible to recommend particular dimensions or siting arrangements that will prospectively guarantee satisfactory performance of a cabinet in all situations. 5.5 If cabinets are joined together it is strong

38、ly recommended that the junctions should be airtight and that care should be taken to ensure that they do not put undue stress on the cabinets or on any junction or adaptor pieces. Sealing gaskets or mating surfaces should be positioned such that they do not leave internal cavities or crevices. NOTE

39、 Attention should be paid to vibration as, if it is excessive, damage to seals and gaskets can occur. 5.6 To avoid disturbances to the safety cabinet and its operator, consideration should be given to the following. a) The distance from the plane of the aperture to any circulation space should be at

40、 least 1 000 mm, so as to preserve a zone undisturbed by anyone other than the operator (see Figure 1a). b) The distance between the front aperture and a bench opposite it should ideally be at least 1 500 mm (see Figure 1b). However, containment performance is not likely to be affected if this dista

41、nce is reduced, for instance to enable an operator to use the bench behind, whilst working at the cabinet. In this case operator movement over a smaller distance might cause less air disturbance.BS 5726:2005 BSI 24 March 2005 3 c) There should be no opposing wall (or other obstruction likely to affe

42、ct the airflow) within 2 000 mm of the front aperture (see Figure 1c). d) Safety cabinets should not be installed in positions where they are likely to be affected by other items of equipment. In particular the distance to the aperture of an opposing safety cabinet, fume cupboard or the edge of a lo

43、cal exhaust ventilation outlet should be not less than 3 000 mm (see Figure 1d). e) Any room air supply diffuser should not be within 1 500 mm of the front aperture. If there are large numbers of safety cabinets in a laboratory this recommendation may be difficult to implement, but where diffusers h

44、ave to be placed in close proximity to a safety cabinet their air handling rates need to be low to ensure low discharge velocities. f) A safety cabinet should not be positioned with either side closer than 300 mm to a wall or similar obstruction (see Figure 1e). g) Large obstructions (e.g. an archit

45、ectural column) projecting beyond the plane of the aperture should not be within 300 mm of the side of the safety cabinet (see Figure 1f and Figure 1g). h) Doorways should not be within 1 500 mm of the aperture or within 1 000 mm of the side of the safety cabinet (see Figure 1h) except where a door

46、includes air transfer grills, in which case protection factor testing should be carried out to ascertain a suitable distance. 5.7 The position of a safety cabinet should be such that the spatial requirements (e.g. vision, lighting and convenience of access) of the operator and personnel working near

47、by are met. When a cabinet is installed on a bench top, the leading edge should be flush with or slightly overhanging the edge of the bench top. NOTE 1 Typical problems and their solutions are illustrated in Figure 2. NOTE 2 There should not be an open space between the leading edge of the cabinet a

48、nd the front of the bench as this could create turbulence in front of the aperture. It also provides an obstacle which could adversely affect airflow across the cabinet face. 6 Make-up air systems 6.1 Safety cabinets should be installed only after there has been consideration of the details of the m

49、ake-up air system necessary to replace all of the air entering the safety cabinets in the laboratory. The safety cabinets and other air extraction points together with the make-up air supply in the laboratory should be regarded as an integral system. The air supply system should be such that it does not compromise the performance of the safety cabinets. 6.2 The high air change rate in the laboratory resulting from a multiple safety cabinet installation, or from a single installation