1、BRITISH STANDARD BS 4376-1: 1991 Electrically operated blood storage refrigerators Part 1: Specification for closed reach-in typesBS4376-1:1991 This British Standard, having been prepared under the directionof the Refrigeration, Heating and Air Conditioning Standards Policy Committee, waspublished u
2、nder the authorityof the Standards Boardand comes into effect on 29 March1991 BSI 07-1999 The following BSI references relate to the work on this standard: Committee reference RHE/19 Draft for comment 89/72861 DC ISBN 0 580 19313 6 Committees responsible for this British Standard The preparation of
3、this British Standard was entrusted by the Refrigeration, Heating and Air Conditioning Standards Policy Committee (RHE/-) to Technical Committee RHE/19, upon which the following bodies were represented: Agricultural and Food Research Council British Refrigeration Association British Retailers Associ
4、ation Co-operative Union Department of Health Ice Cream Federation Limited Institute of Refrigeration Institution of Electrical Engineers Institution of Environmental Health Officers Institution of Grocery Distribution London Refrigeration Society Ministry of Agriculture, Fisheries and Food Retail C
5、onsortium United Kingdom Association of Frozen Food Producers The following bodies were also represented in the drafting of the standard, through subcommittees and panels: Association of Manufacturers of Domestic Electrical Appliances British Blood Transfusion Society British Laboratory Ware Associa
6、tion Institute of Medical Laboratory Sciences Amendments issued since publication Amd. No. Date CommentsBS4376-1:1991 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Definitions 1 3 Classification 1 4 Materials and design 1 5 Performance 3 6 Tests 4 7 Ma
7、rking and information 4 Appendix A Methods of test 5 Appendix B Care and maintenance 5 Table 1 Capacity of blood storage refrigerators 1 Publication(s) referred to Inside back coverBS4376-1:1991 ii BSI 07-1999 Foreword This Part of BS4376 has been prepared under the direction of the Refrigeration, H
8、eating and Air Conditioning Standards Policy Committee. It is a partial revision of BS4376:1982. This Part of BS4376 covers all sizes of closed reach-in type refrigerators designed and equipped for the storage of whole blood and red cell components that need to be kept within specified limits of tem
9、perature. The refrigerators are intended for use in hospitals and blood collecting centres. Facilities for the storage of frozen blood products are excluded. The requirements specified in this Part supersede the requirements of BS4376:1982 for closed reach-in type refrigerators, which is amended to
10、delete those requirements. This Part of BS4376 specifies particular requirements for the proper storage of unfrozen blood when in refrigerators complying with BS2501. It is envisaged that further Parts will be published to cover other types of blood product storage facilities. Appendix B describes t
11、he routine care and maintenance which should be carried out in order to ensure that the refrigerators operate effectively in use. For safe operation of refrigeration appliances and systems, reference should be made to BS4434. A British Standard does not purport to include all the necessary provision
12、s 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 legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 to6, an inside
13、back cover and a back cover. This 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.BS4376-1:1991 BSI 07-1999 1 1 Scope This Part of BS4376 specifies particular requirements for performance
14、, testing and marking for refrigerators of the closed reach-in type, constructed in accordance with BS2501, which are intended for the storage of whole blood and red cell components at a temperature of4 2 C 1) . The refrigerators are for use in climates having dry bulb temperatures and relative humi
15、dities, respectively, from16C and80% r.h. to40C and40% r.h. This Part of BS4376 does not apply to the storage of blood grouping reagents. This Part of BS4376 does not apply to refrigerated vehicle mounted blood storage facilities. NOTE 1It is recommended that, except for very small storage capacity
16、requirements, separate refrigerators should be provided for stock blood and for cross-matched blood reserved for particular individuals. NOTE 2It is important that refrigerators for storage of whole blood and red cell components should be used exclusively for that purpose. NOTE 3The titles of the pu
17、blications referred to in this standard are listed on the inside back cover. 2 Definitions For the purposes of this British Standard the definitions given in BS2501 apply, together with the following. 2.1 type1 refrigerator refrigerator fitted with a single refrigeration system 2.2 type2 refrigerato
18、r refrigerator fitted with two independent refrigerating systems with manually operated or automatic change-over control so that, in the event of failure of any part of one system, the other may be brought into operation 3 Classification 3.1 Capacity The capacity of refrigerator cabinets in units of
19、 blood shall be classified in accordance with Table 1. Table 1 Capacity of blood storage refrigerators 3.2 Refrigerator type The refrigerator type shall be classified type1 or type2 as defined in2.1 or2.2. NOTEThe purchaser should recognize that cases arise where a second independent refrigeration s
20、ystem is required, and it is recommended that in these cases a standby system should be provided where practicable. 4 Materials and design 4.1 General Blood storage refrigerators shall comply with BS2501 and4.2 to4.11 of this standard. NOTE 1It is recommended that there should be a minimum of150mm c
21、learance of the cabinet body from the floor to allow access for cleaning. Levelling screws should be provided for adjusting the level of the cabinet, except for bench mounted and pass through appliances. NOTE 2It is recommended that castors, with facilities for braking, are provided for ease of move
22、ment. 4.2 External and internal finish The exterior and interior of the cabinet shall be of any of the following materials: a) stainless steel sheet complying with BS1449-2; b) aluminium sheet complying with BS1470; c) glass reinforced plastics; d) primed carbon steel with a corrosion resistant coat
23、ing. NOTEThe interior lining should be smooth. It should be scratch, stain and corrosion resistant, of robust construction and capable of being easily cleaned. Any seams should be sealed. Materials used for construction and sealing should not be degraded by commonly used sterilizing agents. 4.3 Ther
24、mal insulation The thermal insulation of refrigerators shall have a thermal transfer coefficient not greater than0.35W/(m 2 K). The insulation shall be vapour sealed. NOTEThe preferred type of insulation is that which is foamed in place. If slab type insulation is used it shall be bonded at joints a
25、nd to both external and internal linings. 1) The storage temperature range is consistent with that specified in the publication on the Council of Europe “Quality Control in Blood Transfusion Services1986” and the United Kingdom Health Departments “Handbook of Transfusion Medicine1989”. Both publicat
26、ions are available from HMSO, PO BOX276, London SW8 5ET. Class Capacity (units of blood) a 1 2 3 up to50 50 to150 over150 a For comparison purposes capacities are based on units of red cell components of450mL.BS4376-1:1991 2 BSI 07-1999 A thermal break shall be provided between the inner and outer s
27、urfaces. Loose insulation shall not be used. 4.4 Shelves, drawers, and/or partitions These shall be capable of sustaining a loading of100kg/m 2without permanent deformation. They shall be fabricated from either stainless steel or carbon steel coated with durable food grade plastics material. To allo
28、w cleansing of surfaces, they shall be readily removable. Shelves, drawers and partitions including ancillary fittings such as baskets, drawers and hooks shall be designed to allow circulation of air and to prevent the intrusion of blood packs into those areas required for air circulation. Blood pac
29、ks shall also be prevented from coming into contact with the inner walls of the cabinets. Shelves, drawers, and partitions shall be arranged to maintain a minimum air space of30mm from the inner cabinet base and side walls. NOTEDrawers should be adjustable and smooth with no sharp edges, corners or
30、burrs. Shelf supports should be durable, corrosion resistant, adequately supported and able to withstand continuous use. Sliding or rotary shelves shall be capable of being moved to their full extent when loaded. 4.5 Lighting Refrigerators shall be provided with at least one light fixed in a positio
31、n where the contents of the storage cabinet can be seen without reliance on external lighting. The lighting circuit shall be controlled either by a door operated switch fitted to each opening or by a separate switch. NOTE 1It is recommended that a low thermal output fluorescent lighting luminaire is
32、 used to minimize heat input to the refrigerated area. NOTE 2It is important that any light incorporated in a cabinet is so designed, guarded or located as to be protected against mechanical damage which may arise during normal use of the refrigerator. NOTE 3Lamp holders and fittings should be prote
33、cted against mechanical damage and moisture accumulation. 4.6 Doors Doors shall be of self-closing type each fitted with a device for holding the door open at an angle permitting free opening of all inner doors or flaps and the removal of shelves, trays, etc. Door sealing gaskets shall have an effec
34、tive seal over their entire length which shall be tested in accordance with BS2501. The entry of ambient air to the compartment when the main door is open shall be restricted by either or both of the following means: a) inner doors or flaps; b) where sliding shelves or trays are fitted, a solid faci
35、ng extending across the full width and the full height between adjacent shelves at the front of the cabinet. NOTEIt is recommended that provision is made in inner doors, flaps or solid facings to allow visual examination of the contents of shelves, when closed. Means shall be provided for locking th
36、e outer door(s) including duplicate keys. 4.7 Stability For appliances fitted with extendable drawers or shelves, the cabinet shall be stable when fully loaded and mounted in accordance with the manufacturers instructions, with the door(s) open at90 and with50% of the complement of drawers/shelves i
37、n their fully extended position. Where an odd number of drawers/shelves are provided, the cabinet shall be stable when50% plus an extra half of a drawer/shelf are fully extended. For example, a cabinet with six drawers shall be stable when three are fully extended and a cabinet with seven drawers sh
38、all be stable when three and a half plus an extra half, i.e.four, are fully extended. A permanent label shall be fitted in a prominent position within the cabinet indicating that not more than one drawer or shelf shall be extended at any one time. NOTEAdditional stability may be provided by means of
39、 a bracket fitted to the unit and anchored to the wall or floor, provided that the manufacturer supplies clear instructions and the unit can be readily removed for cleaning purposes. 4.8 Refrigerating system 4.8.1 General Refrigerating systems shall comply with BS2501, together with 4.8.2 to4.8.4. 4
40、.8.2 Noise The refrigerating system shall not produce undue noise or vibration. NOTEIt is recommended that the sound pressure level should not exceed65dBA when measured1.5m from the noise source in an anechoic space. 4.8.3 Defrosting The refrigerating system shall be designed to ensure that the evap
41、orator, drip tray and adjacent cold surfaces are automatically defrosted with sufficient regularity to maintain the performance requirements of this standard (see5.1). 4.8.4 Air circulation Where air circulation within the refrigerated space is provided by a motor driven fan, or if a forced air cool
42、ing unit is employed, a door operated switch shall be fitted to each external door so that the fan motor circuit is energized only when all external doors are closed.BS4376-1:1991 BSI 07-1999 3 4.9 Electrical equipment Electrical equipment shall comply with BS2501. NOTEElectrical installation should
43、 be carried out in accordance with the current edition of the IEE regulations published by the Institution of Electrical Engineers. 4.10 Instruments and control equipment 4.10.1 Indicating thermometer Each refrigerator shall be supplied and fitted with an indicating thermometer having the following
44、characteristics. a) Read out. The read out shall be either analogue or digital and shall be clearly readable from outside the refrigerator with the door closed. b) Scale. The scale, which shall be graduated in degrees Celsius, shall include the range between 5C and +20C. NOTE 1Sensing element. The s
45、ensing element of the thermometer should be located in air in a position such that it responds to the temperature of the air surrounding the blood containers without being immediately affected by warm air entering when a door is opened. NOTE 2Accuracy. The thermometer should indicate the air tempera
46、ture to an accuracy of within +0.5C over the range0C to10C. 4.10.2 Recording thermograph Each refrigerator shall be supplied with a recording thermograph having a chart or print-out and with the following characteristics. a) Drive. The recording systems shall be capable of operating for24h on interr
47、uption of the mains power supply. b) Chart. The access door to the chart shall be provided with a keyed lock. The chart shall include the temperature span between 5C and +20C and be capable of recording temperature for at least7 days. It shall be graduated in degrees Celsius with a maximum increment
48、 of1C. The chart marking system shall be capable of marking a continuous record for at least7 days. NOTEIt is desirable that the7 day temperature record be visible externally. The distance between individual increments of1C should be not less than1mm. The marking system should be of fibre tip or pre
49、ssure sensitive types. c) Sensing element. The heat absorbent capacity of the sensing element plus container shall be equivalent to the thermal capacity of200mL of water. The container shall be placed inside the refrigerator working space at one of the least favourable high temperature positions determined by the method in A.3 and as practicable to the appliance design. NOTE 1The sensing element should be readily accessible for testing. NOTE 2It is important that the sensing element is constructed of corrosion resistant material such as stainless steel. d)
