BS 4376-2-1996 Electrically operated blood storage refrigerators - Specification for cabinets for the storage of frozen plasma《电动血液冷藏箱规范 第2部分 冷冻血浆储藏柜规范》.pdf

1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS 4376 : Part 2 : 1996 I

2、CS 11.140 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Electrically operated blood storage refrigerators Part 2. Specification for cabinets for the storage of frozen plasmaThis British Standard, having been prepared under the direction of the Engineering Sector Board, was p

3、ublished under the authority of the Standards Board and comes into effect on 15 November 1996 BSI 1996 The following BSI references relate to the work on this standard: Committee reference RHE/19 Draft for comment 91/81704 DC ISBN 0 580 25838 6 BS 4376 : Part 2 : 1996 Amendments issued since publica

4、tion Amd. No. Date Text affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee RHE/19, Commercial refrigerated food cabinets (Cold room and display cases), upon which the following bodies were represented: British Refri

5、geration Association British Retail Consortium Chartered Institute of Environmental Health Co-operative Union Ice Cream Federation Limited Insititute of Refrigeration Institution of Grocery Distribution London Refrigeration Society Ministry of Agriculture, Fisheries and Food United Kingdom Associati

6、on of Frozen Food Producers Department of Health The following bodies were also represented in the drafting of the standard, through subcommittees and panels: BLWA Ltd. (The Association of the Laboratory Supply Industry) British Blood Transfusion Society Co-opted Members Institute of Biomedical Scie

7、nce Department of HealthBS 4376 : Part 2 : 1996 BSI 1996 i Contents Page Committees responsible Inside front cover Foreword ii Specification 1 Scope 1 2 References 2 3 Definitions 2 4 Classification 2 5 Materials and design 2 6 Performance 3 7 Tests 3 8 Marking and information 4 Annexes A (normative

8、) Methods of test 5 B (informative) Care and maintenance 6 List of references Inside back coverii BSI 1996 BS 4376 : Part 2 : 1996 Foreword This Part of BS 4376 has been prepared by Technical Committee RHE/9. It covers all sizes of closed reach-in type cabinets designed and equipped for the storage

9、of prefrozen plasma components that need to be kept within specified limits of temperature. The cabinets are intended for use in hospitals and blood transfusion centres. Some users of cabinets may wish to make use of centralized data logging and alarm systems rather than local alarm and temperature

10、recording devices, so a type B cabinet is specified which allows the user to provide separate alarm systems. It is intended and recommended that type B cabinets are provided with separate temperature recording and alarm functions equivalent to those of type A cabinets. For safe operation of refriger

11、ating appliances and systems, reference should be made to BS 4434. It is recommended that the user should ensure that segregation and suitable access is provided where different types of product are stored in the same facility. Compliance with a British Standard does not of itself confer immunity fr

12、om legal obligations. BSI 1996 1 BS 4376 : Part 2 : 1996 Specification 1 Scope This Part of BS 4376 specifies performance, testing and marking for cabinets of the closed reach-in type, constructed in accordance with BS 2501, which are intended for the storage of prefrozen plasma and plasma products

13、at temperatures of230 C or below. The cabinets are for use in climates having dry bulb temperatures and relative humidities respectively from 16 C and 80 % r.h. to 40 C and 40 % r.h. This Part of BS 4376 does not apply to the following: a) cabinets for the storage of blood grouping reagents; b) refr

14、igerated vehicle mounted blood storage facilities. 2 References 2.1 Normative references This Part of BS 4376 incorporates, by dated or undated reference, provisions from other publications. These normative references are made at the appropriate places in the text and the cited publications are list

15、ed on the inside back cover. For dated references, only the edition cited applies; any subsequent amendments to, or revisions of the cited publication apply to this Part of BS 4376 only when incorporated in the reference by amendment or revision. For undated references, the latest edition of the cit

16、ed publication applies, together with any amendments. 2.2 Informative references This Part of BS 4376 refers to other publications that provide information or guidance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference sho

17、uld be made to the latest editions. 3 Definitions For the purpose of this British Standard the definitions given in BS 2501 apply, together with the following. 3.1 type A cabinet Cabinet fitted with alarm systems and thermograph. 3.2 type B cabinet Cabinet with no temperature alarm or thermograph fi

18、tted. This type is provided with positions for sensing elements only, so that when connected to a central alarm system the requirements of 5.10 can be provided remotely. NOTE. Type B cabinets should not be used without means of providing temperature record or alarm functions equivalent to those prov

19、ided by type A cabinets. 4 Classification The cabinet shall be classified type A or type B as defined in 3.1 and 3.2 respectively. (See 8.1d). 5 Materials and design 5.1 General Cabinets shall conform to BS 2501 and to 5.2 to 5.10 of this standard. NOTE 1. It is recommended that there should be a mi

20、nimum clearance of 150 mm of the cabinet body from the floor to allow access for cleaning. Except for bench mounted cabinets, levelling screws should be provided for adjusting the level of the cabinet and pass-through appliances. NOTE 2. It is recommended that castors, with facilities for braking, a

21、re provided for ease of movement. 5.2 Internal finish The interior lining shall be scratch, stain and corrosion resistant under normal conditions and when used in accordance with the manufacturers instructions, of robust construction and capable of being easily cleaned. Any seams shall be sealed. Ma

22、terials used for construction and sealing shall not be degraded by commonly used sterilizing agents, or adversely affected by the operating temperature of the cabinet. 5.3 Thermal insulation The thermal insulation of cabinets shall have a thermal transfer coefficient not greater than 0.35 W/m 2 K. T

23、he insulation shall be vapour sealed. NOTE. The preferred type of insulation is that which is foamed in place. If slab type insulation is used it shall be bonded at joints and to both external and internal linings. A thermal break shall be provided between the inner and outer surfaces. Loose insulat

24、ion shall not be used. 5.4 Shelves, drawers and/or partitions These shall be capable of sustaining a loading of 100 kg/m 2 without permanent deformation. Fittings which are intended to be removed for cleaning shall be readily removable. In forced-air-circulation models there shall be sufficient spac

25、e to allow for full-air-circulation, equivalent to the capacity of the air-circulating fan. NOTE. The cabinet should be loaded in accordance with the manufacturers instructions to prevent intrusion of product packages into air ducts. Movable shelves shall be capable of being moved to their full exte

26、nt when loaded.2 BSI 1996 BS 4376 : Part 2 : 1996 5.5 Doors When tested in accordance with BS 2501, door sealing gaskets shall have an effective seal over their entire length. Where chest type cabinets are fitted with a hinged lid, which shall be spring balanced, insulated and fitted with a gasket s

27、eal. The hinges shall hold the lid open to allow easy access to contents. When the lid is closed the gasket shall ensure an airtight seal. Means shall be provided for locking the doors or the lids which shall include duplicate keys. Where a latching or locking device is fitted a warning label shall

28、be permanently fitted to the cabinet near to the latch or lock advising that, for safety, the latch or lock should be removed on disposal of the cabinet. 5.6 Stability For appliances fitted with extendable drawers or shelves, the cabinet shall be stable when fully loaded and mounted in accordance wi

29、th the manufacturers instructions, with the door(s) open at 90 and with 50 % of the complement of drawers/shelves in their fully extended position. Where an odd number of drawers/shelves are provided, the cabinet shall be stable when 50 % plus an extra half of a drawer/shelf are fully extended. For

30、example, a cabinet with six drawers shall be stable when three are fully extended and a cabinet with seven drawers shall 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 on the cabinet indicating that not mor

31、e than one drawer or shelf should be extended at any one time. NOTE. Additional stability may be provided by means of 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.

32、5.7 Refrigerating system 5.7.1 General Refrigerating systems shall conform to BS 2501, together with 5.7.2 and 5.7.3. NOTE. The refrigerating system should not produce undue noise or vibration. It is recommended that the sound pressure level should not exceed 65d BA when measured 1.5 m from the nois

33、e source in an anechoic space. 5.7.2 Defrosting Where automatic defrosting is provided the refrigerating system shall be designed to ensure that the evaporator, drip tray and adjacent cold surfaces are automatically defrosted with sufficient regularity to maintain the performance requirements of cla

34、use 6. 5.7.3 Air circulation Where air circulation within the refrigerated space is provided by a motor-driven-fan, or if a forced-air cooling-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 cl

35、osed. 5.8 Electrical equipment Electrical equipment shall conform to BS 7671. NOTE. Electrical installation should be carried out in accordance with the current edition of BS 7671. 5.9 Instruments and control equipment 5.9.1 General Type A cabinets shall conform to 5.9.2 and 5.9.3. Type B cabinets s

36、hall conform to 5.9.2 and shall be provided with a position for the sensing element as specified in 5.9.3.2. NOTE. It is recognized that purchasers may wish to use a data logging system. If such a system is to be used the purchaser should consider the following factors. a) temperature range; b) accu

37、racy; c) sampling rate; d) transfer of data to hard copy records. Suggested values for these parameters are: i) temperature range resolution, 2 C; ii) accuracy, 1 C; iii) sampling frequency, 20 min; iv) frequency of transfer of data, weekly. 5.9.2 Indicating thermometer Each cabinet shall be supplie

38、d and fitted with an indicating thermometer having the following characteristics. a) Read out The read out shall be either analogue or digital and shall be clearly readable from outside the cabinet with the door closed. b) Scale The scale, which shall be graduated in degrees Celsius, and shall inclu

39、de the range +20 C to 240 C. NOTE 1. The sensing element of the thermometer should be located in air in a position such that it responds to the temperature of the air surrounding the frozen plasma containers without being immediately affected by warm air entering when a door is opened. NOTE 2. The t

40、hermometer should indicate the air temperature to an accuracy of within 1 C over the range + 20 C to2 40 C. BSI 1996 3 BS 4376 : Part 2 : 1996 5.9.3 Recording thermograph 5.9.3.1 Chart drive Each type A cabinet shall be supplied with a recording thermograph having a chart or print-out and with the f

41、ollowing characteristics. a) Drive. The recording systems shall be capable of operating for 24 h on interruption of the mains power supply. b) Chart. The access door to the chart shall be provided with a lock and keys. The chart shall include the temperature range between 0 C and250 C and shall be c

42、apable of recording temperature for at least 7 days. It shall be graduated in degrees celsius with a maximum increment of 2 C. The marking system shall be capable of marking a continuous record for at least 7 days. NOTE. A 7 day temperature record should be visible externally. The distance between i

43、ndividual increments of 2 C should be not less than 1 mm. The marking system should be of fibre tip or pressure sensitive types. c) Accuracy. The recording thermograph shall record the temperature to within an accuracy of 1 C over the range 0 C to250 C (see A.1). d) The thermograph shall record the

44、temperature measured at the sensing element as specified in 5.9.3.2. 5.9.3.2 Sensing element The sensing element shall be attached to a container. The heat absorbent capacity of the container shall be equivalent to the thermal capacity of 100 ml of water. The container shall be placed inside the cab

45、inet 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, without being immediately effected by warm air entering when a door or lid is opened. NOTE. It is important that the sensing element is constructed

46、 of corrosion resistant material. 5.10 Alarm systems 5.10.1 General Alarm systems shall be provided as follows. a) Type A cabinets shall conform to 5.10.2 to 5.10.6. b) Type B cabinets shall be provided with sensors to provide remote operation of alarms conforming to 5.10.3 and 5.10.4 and a position

47、 for fitting a sensor equivalent to 5.10.2. NOTE. It is recommended that any switching and/or muting device should incorporate a reactivating mechanism which will ensure that the audible alarm is automatically re-energized after a predetermined period (not exceeding approximately 15 min). 5.10.2 Tem

48、perature drift An audible and visual alarm shall operate if the simulated product temperature measured using the sensing element at the sensor position defined in 5.9.3.2 rises above 232 1 C. 5.10.3 Interruption of electricity supply A battery operated audible and visual alarm shall operate in the e

49、vent of interruption of the electricity supply to the cabinet. This alarm system shall be provided with a manual or interrupted muting device for the audible alarm only. NOTE. It is recommended that provision should be made for checking the ability of the batteries to hold an effective charge and that the battery system for the alarm should be separate from that for the thermograph. 5.10.4 Door alarm An alarm shall be fitted to indicate if the door is left ajar. When tested in accordance with A.4 the alarm shall energize after a predetermined time. 5.