BS 2646-2-1990 Autoclaves for sterilization in laboratories - Guide to planning and installation《实验室灭菌用高压釜 第2部分 设计与安装指南》.pdf

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1、BRITISH STANDARD BS 2646-2: 1990 Autoclaves for sterilization in laboratories Part 2: Guide to planning and installationBS2646-2:1990 This British Standard, having been prepared under the direction of the Laboratory Apparatus Standards Policy Committee, waspublished under the authorityof the Board o

2、f BSI andcomes into effect on 31 October 1990 BSI 03-1999 The following BSI references relate to the work on this standard: Committee reference LBC/35 Draft for comment 90 52264 DC ISBN 0 580 18995 3 Committees responsible for this British Standard The preparation of this British Standard was entrus

3、ted by the Laboratory Apparatus Standards Policy Committee (LBC/) to Technical Committee LBC/35, upon which the following bodies were represented: Associated Offices Technical Committee Association of British Health Care Industries Association of British Sterilizer Manufacturers Association of Clini

4、cal Pathologists Association of National Health Service Supplies Officers British Dental Trade Association British Surgical Trades Association Central Sterilising Club Department of Health Health and Safety Executive Infection Control Nurses Association Institute of Hospital Engineering Institute of

5、 Purchasing and Supply Institute of Sterile Services Management Joint Committee of Professional Nursing, Midwifery and Health Visiting Associations (England) Medical Sterile Products Association National Blood Transfusion Service Public Health Laboratory Service Regional Hospital Boards Engineers As

6、sociation Royal College of Pathologists Royal Pharmaceutical Society of Great Britain Scottish Health Services Society for General Microbiology Stainless Steel Fabricators Association of Great Britain The following bodies were also represented in the drafting of the standard, through subcommittees a

7、nd panels: British Glass Manufacturers Confederation British Laboratory Ware Association Copper Development Association Institute of Medical Laboratory Sciences Manufacturing Science Finance Milk Marketing Board Ministry of Agriculture, Fisheries and Food Royal Association of British Dairy Farmers S

8、ociety for Applied Bacteriology Amendments issued since publication Amd. No. Date CommentsBS2646-2:1990 BSI 03-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Definitions 1 3 Planning 1 4 Heating and ventilation 2 5 Noise transmission 2 6 Services to autoclaves

9、 and associated areas 3 7 Autoclave discharge 4 Publication(s) referred to Inside back coverBS2646-2:1990 ii BSI 03-1999 Foreword This Part of BS2646 has been prepared under the direction of the Laboratory Apparatus Standards Policy Committee. It provides guidance on the planning and installation of

10、 laboratory autoclaves specified in Part1 of this standard. It covers the installation of autoclaves for sterilization of materials and goods including those which may be contaminated with organisms categorized in Hazard Groups1,2 and3 (see footnote to clause1). It does not cover materials infected

11、with any organisms in Hazard Group4. Autoclaves covered by BS2646 are not intended for the sterilization of goods or fluids directly concerned with patient care nor for fabrics subjected to sterilization which are required to be dry at the end of the cycle. Sterilizers suitable for those application

12、s are covered by BS3970. This revision of BS2646 will comprise several separate Parts as follows: Part 1: Specification for design and construction; Part 2: Guide to planning and installation; Part 3: Guide to safe use and operation; Part 4: Guide to maintenance; Part 5: Specification for functional

13、 design and performance. Part 1 was published in1988 and Parts3 to5 are in preparation. It is anticipated that autoclaves to which this standard applies will be used for the following processes: a) liquids sterilization (see2.2). b) equipment and glassware sterilization (see2.3). c) make-safe (see2.

14、4). An analysis of all the factors covered in this Part of BS2646 should be carried out at the earliest possible planning stage. 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. Compli

15、ance 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, pagesi andii, pages1 to 6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have ha

16、d amendments incorporated. This will be indicated in the amendment table on theinside front cover.BS2646-2:1990 BSI 03-1999 1 1 Scope This Part of BS2646 gives guidance on the planning for, and installation in laboratories of, autoclaves for the sterilization of material and equipment, including tho

17、se which may be contaminated with organisms categorized as Hazard Groups1,2, or3 1) . It does not cover the installation of autoclaves used for material contaminated with organisms categorized as Hazard Group4, for which complete containment of condensate is considered to be essential. NOTEThe title

18、s of the publications referred to in this standard are listed on the inside back cover. 2 Definitions For the purposes of this Part of BS2646 the definitions given in Part1 apply, together with the following. 2.1 autoclave a machine, which incorporates a steam pressure vessel, designed to sterilize

19、laboratory materials and equipment NOTEIt may also be used for other processes, such as heat disinfection and heat treatment, which may be selected according to the laboratory requirements and the nature of the load. 2.2 liquids sterilization a process to sterilize a variety of liquids, including cu

20、lture media, in containers of various types NOTEDue to the heat sensitive nature of some constituents of nutrient media, time and temperature controls should allow the user to select cycle characteristics separately for each load. 2.3 equipment and glassware sterilization a process strictly limited

21、to the sterilization of clean items which do not contain fluids 2.4 make-safe a process which reduces the microbial content of contaminated material so that it can be handled and disposed of without causing an infection hazard or environmental contamination NOTEMaterial may include single-use items

22、to be discarded, e.g. plastics specimen tubes and culture plates, and/or items for cleaning and reuse, e.g. glass containers and filter assemblies. 3 Planning 3.1 General Autoclaves are often heavy and bulky pieces of equipment. The accessibility of the chosen site and maximum floor loadings should

23、therefore be considered, together with autoclave capacity, plant room and loading area design and whether the autoclave is to be front loading or top loading. 3.2 Site access Particular attention should be given to the following: a) sizes of door openings; b) staircases and steps; c) size and load c

24、apacity of lifts. NOTEIt may be possible to remove external panels and pipework thereby reducing the overall autoclave size. 3.3 Floor loading Building construction methods require that the permanent position of equipment weighing above a specified value be restricted to designated floors or areas o

25、f floors. NOTE 1The total mass of an autoclave of chamber capacity290L could be as much as700kg. The inclusion of a steam generator (i.e. types II or III of BS2646-1) could increase the total mass to approximately1000kg. NOTE 2Information to be supplied by the manufacturer should include the expecte

26、d total weight of the autoclave and point loading when fully loaded. 3.4 Floor surface It should be anticipated that leakages from pipework connections and spillage in the vicinity of the autoclave may occur. For these reasons flooring finishes in the loading and plant room areas should be non-slip

27、and impervious to water. To facilitate cleaning, the floor should fall naturally to an open gully (see also7.2 note2). 3.5 Autoclaving capacity The capacity required will depend on the workload of the laboratory, the autoclave cycle time, and the purchasing policy for single-use sterile apparatus an

28、d media. The size and number of autoclaves should allow the expected daily workload to be processed within normal laboratory working hours. Where possible, autoclaves designated specifically to making safe contaminated waste should be installed; a separate loading room should be provided for these.

29、It is recommended that a minimum of two autoclaves be installed in a laboratory suite. 1) The groups of organisms referred to are those listed in “Categorization of pathogens according to hazard and categories of containment” produced by the Advisory Committee on Dangerous Pathogens and published by

30、 HMSO.BS2646-2:1990 2 BSI 03-1999 NOTEWhere a single autoclave is provided, contingency plans should be made for the safe disposal of contaminated waste in the event of breakdown. It is recommended that autoclaves with chambers which exceed450L should be of typeI of BS2646-1 (seealso6.1). 3.6 Siting

31、 Autoclaves should be installed so as to facilitate the provision of services to them. Siting near an outside wall will assist in the provision of ventilation and drainage. Autoclaves for the sterilization of waste materials should be readily accessible and should be sited in, or as close as possibl

32、e to, the area in which the potentially contaminated material is examined, e.g.the microbiology laboratory suite. NOTE 1It is not advisable to transport waste material through rooms where it would not normally be stored or handled. A microbiology media preparation area will also require the provisio

33、n of autoclaves and therefore should be located in the same vicinity. Access for loading and unloading sterilized fluids and apparatus, but not for contaminated discards, should be directly from the media preparation area. NOTE 2If the volume of contaminated material does not justify the provision o

34、f an autoclave in the laboratory suite, suitable arrangements should be made for its secure transport to an autoclave elsewhere. (Guidance on this subject will be given in BS2646-3.) 3.7 Space requirements 3.7.1 Maintenance access Adequate clearance is necessary for maintenance. This should be1000mm

35、 around parts to which access for routine maintenance is required. For top loading autoclaves sited in a laboratory room, a minimum distance of300mm behind the machines is recommended although additional clearance may be required for the withdrawal of any electrical or ancillary equipment rearwards

36、from the autoclave. Minimum clearance between autoclaves should be1000mm; additional clearance may be needed if sideways sliding doors are fitted. Steam generators, which are not part of the autoclave, should have similar clearance to that of an autoclave. Space should be available for the installat

37、ion and maintenance of air compressor/receiver assemblies, water treatment plants, water break tanks and water pressure pumping systems where these are planned. 3.7.2 Operator access Where carriage and trolley loading is required the minimum clearance for access to the autoclave should be2000mm or t

38、wice the length of the carriage loading system, whichever is the greater. Shelves for the storage of empty discard-containers should not impede door or trolley movement or restrict access to autoclaves. 4 Heating and ventilation 4.1 General Autoclaves can be expected to produce heat, some steam and

39、foul odours particularly on unloading after a make-safe cycle. Mechanical ventilation is therefore necessary to maintain the desired air flow pattern in the vicinity of the autoclaves; this should be by a total loss system. 4.2 Ventilation design Ventilation design should take particular note of the

40、 energy output of the autoclave(s) and its effect on the working environment. 4.3 Separate plant room Where the laboratory and plant room are separated by the autoclave(s) (in the case of front loading autoclaves) the loading area should be at a lower pressure than a main laboratory corridor and at

41、a higher pressure than the plant room. There will be air movement past the autoclave door mechanisms into the plant room. The discharge to the outside should not be sited where the extracted air will be drawn into the building via windows or ventilation inlets. Frost protection should be provided to

42、 the plant room, e.g. by the use of thermostatically controlled background heating. 5 Noise transmission The room in which the autoclave is installed should be planned and designed so that the noise transmitted does not give rise to excessive noise levels in the autoclave room or adjoining rooms. As

43、sessment of noise levels should take into consideration the room conditions which will exist after installation of the autoclave. NOTEFor autoclaves installed in the laboratory room, large air compressors or vacuum pumps installed within the autoclave frame or alongside the autoclave are likely to c

44、reate a level of noise which is unacceptable.BS2646-2:1990 BSI 03-1999 3 6 Services to autoclaves and associated areas 6.1 Steam service 6.1.1 General A supply of saturated steam from an external source is required for autoclaves of typeI of BS2646-1. The steam can be generated within the laboratory

45、 building or generated elsewhere and piped to the laboratory. Where it is not possible to maintain a continuous steam supply with the properties recommended in6.1.2 to6.1.4, one of the following should be used: a) an autoclave which generates its own steam (types II or III of BS2646-1); b) an autocl

46、ave in which steam is generated within the autoclave chamber (type IV of BS2646-1). See also 3.5. 6.1.2 Steam supply Where steam is supplied from elsewhere, the pipeline which supplies the steam should be fitted with a pressure gauge inside the plant room (or laboratory room) and terminated within2m

47、 of the autoclave installation by means of an isolation valve. The pressure gauge should be an industrial gauge of the bourdon type and complying with BS1780. Adequate trapping, straining and venting of the steam supply system, good installation practice to remove condensate and non-condensable gase

48、s, together with efficient thermal insulation are important to the operation of laboratory autoclaves. 6.1.3 Steam supply pressure Steam pressure at the isolation valve at the end of the steam supply should be not less than3bar 2) . A reducing valve or other automatic device should be fitted to redu

49、ce the pressure of the steam delivered to the autoclave to not more than the maximum working pressure of the autoclave (see2.2 of BS2646-1:1988). 6.1.4 Dryness value Autoclaves in laboratories are not intended for the sterilization of fabrics which are required to be dry at the end of the cycle. For this reason and because of the nature of the loads, dryness values of steam supplied to laboratory autoclaves need comply only with the following. a) The need to minimize condensate in the supply line to the autoclave which would affect the efficient and reliable operatio