BS 2646-5-1993 Autoclaves for sterilization in laboratories Methods of test for function and performance《实验室高压灭菌釜 功能和性能试验方法》.pdf

1、BRITISH STANDARD BS 2646-5: 1993 Autoclaves for sterilization in laboratories Part 5: Methods of test for function and performanceBS2646-5:1993 This British Standard, having been prepared under the directionof the Laboratory Apparatus Standards Policy Committee, was published underthe authority of t

2、he Standards Board and comes intoeffect on 15 March 1993 BSI 01-1999 The following BSI references relate to the work on this standard: Committee reference LBC/35 Draft for comment 91/53016 DC ISBN 0 580 21337 4 Committees responsible for this British Standard The preparation of this British Standard

3、 was entrusted by the Laboratory Apparatus Standards Policy Committee (LBC/-) to Technical Committee LBC/35, upon which the following bodies were represented: Association of British Health Care Industries Association of National Health Service Supplies Officers Association of Sterilizer and Disinfec

4、tor Equipment Manufacturers British Dental Trade Association Central Sterilising Club Department of Health Health and Safety Executive Infection Control Nurses Association Institute of Hospital Engineering Institute of Purchasing and Supply Institute of Sterile Services Management Joint Committee of

5、 Professional Nursing, Midwifery and Health Visiting Associations (England) Medical Sterile Products Association National Blood Transfusion Service Public Health Laboratory Service Regional Hospital Boards Engineers Association Royal College of Pathologists Royal Pharmaceutical Society of Great Brit

6、ain 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 and panels: Association of Clinical Pathologists British Glass Manufacturers Confederation British Laborator

7、y Ware Association Copper Development Association Institute of Medical Laboratory Sciences Manufacturing Science Finance Ministry of Agriculture, Fisheries and Food Royal Association of British Dairy Farmers Society for Applied Bacteriology Amendments issued since publication Amd. No. Date CommentsB

8、S2646-5:1993 BSI 01-1999 i Contents Page Committees responsible Inside front cover Foreword ii Section 1. General 1.1 Scope 1 1.2 References 1 1.3 Definitions 1 1.4 Test instruments and gauges 1 Section 2. Tests for safe function 2.1 Safety valves 3 2.2 Tests on door interlocks 3 2.3 Tests on discha

9、rge of chamber contents 3 2.4 Tests on double door autoclaves 3 Section 3. Tests for performance 3.1 Instrument accuracy, steady state and operating cycle controls: performance tests 4 3.2 Liquids sterilization: performance test 4 3.3 Make-safe: performance tests 5 3.4 Equipment and glassware steril

10、ization performance tests 8 List of references Inside back coverBS2646-5:1993 ii BSI 01-1999 Foreword This Part of BS 2646 has been prepared under the direction of the Laboratory Apparatus Standards Policy Committee. It describes methods of testing the function and performance of laboratory autoclav

11、es specified in Part 1 of this standard. BS 2646 comprises several separate Parts. The other Parts of the standard are as follows. Part 1: Specification for design, construction, safety and performance; Part 2: Guide to planning and installation; Part 3: Guide to safe use and operation 1) ; Part 4:

12、Guide to maintenance. It is anticipated that autoclaves to which this standard applies will be used for the following processes: a) liquids sterilization; b) make-safe; c) equipment and glassware sterilization; and methods of test are described for each process. BS 2646-3 will describe the stages of

13、 each operating cycle, together with recommended times and temperatures for various processes and safety procedures. 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. Compliance with a

14、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, pages1 to 10, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendme

15、nts incorporated. This will be indicated in the amendment table on theinside front cover. 1) In preparation.BS 2646-5:1993 BSI 01-1999 1 Section 1 Section 1. General 1.1 Scope This Part of BS 2646 describes the methods of test used to verify compliance with the requirements for design, construction,

16、 safety and performance specified in BS 2646-1:1993. This standard covers laboratory autoclaves for the sterilization of goods and material which could be infected with organisms categorized as Hazard Group 1,2 or 3 2) . It does not cover autoclaves for use with material infected with organisms in H

17、azard Group 4, for which complete containment and sterilization of infected condensate is considered to be essential. This standard does not apply to sterilizers or disinfectors used for medical, dental, pharmaceutical or veterinary purposes which are directly concerned with patient care, or those u

18、sed for fabrics subjected to sterilization which are required to be dry at the end of the cycle. These are covered by BS 3970. 1.2 References 1.2.1 Normative references This Part of BS 2646 incorporates, by reference, provisions from specific editions of other publications. These normative reference

19、s are cited at the appropriate points in the text and the publications are listed on the inside back cover. Subsequent amendments to, or revisions of, any of these publications apply to this Part of BS 2646 only when incorporated in it by updating or revision. 1.2.2 Informative references This Part

20、of BS 2646 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 should be made to the latest edition. 1.3 Definitions For the purposes of this Part of BS 2646

21、, the definitions given in BS 2646-1:1993 apply. 1.4 Test instruments and gauges 1.4.1 General Test instruments shall be used to check the accuracy of the autoclave instruments to the requirements of BS 2646-1:1993. They shall also be used to indicate or record pressure and temperatures at specified

22、 locations within the chamber during performance tests. Test gauges shall be used to check the accuracy of autoclave pressure and temperature gauges to the requirements of BS 1780:1985 and BS 5235:1975 respectively. 1.4.2 Calibration and verification of test instruments and gauges 1.4.2.1 Calibratio

23、n of test instruments shall be carried out as follows. a) A temperature reference standard shall be used (see 1.4.2.3). b) Test instruments shall be calibrated in accordance with the manufacturers instructions. 1.4.2.2 Test instruments with sensors connected shall be verified on-site using an indepe

24、ndent reference standard (see 1.4.2.3). NOTETest instruments should not be subjected to rapid variations in ambient temperature. 1.4.2.3 The temperature reference standard shall: a) incorporate a reference standard thermometer traceable to a national primary standard 3) . The thermometer shall inclu

25、de the range 0C to150C with minor mark intervals not exceeding 0.2C; b) incorporate a pocket to accommodate at least three temperature sensors. The temperature gradient through the effective length of each pocket shall not exceed 0.2C and the control accuracy shall be 0.1C in the range 100C to140C.

26、1.4.2.4 The test instrument shall have a manufacturers valid test certificate. 1.4.2.5 Calibration and verification of gauges shall be carried out in accordance with the manufacturers instructions. 1.4.3 Test recorders 1.4.3.1 Temperature test recorders shall have the following characteristics: a) a

27、 scale range which includes 0C to 150C; b) a chart width of not less than 100 mm; c) an accuracy of 0.5C between 120C and130C; d) be of a continuous recording type with a chart speed of not more than 5 mm/min and not less than 2 mm/min or of a dot recording type with print intervals not exceeding 0.

28、5 mm; e) be suitable for use with leads and sensors in accordance with 1.4.6.1. 2) The Hazard Groups of organisms referred to are listed in Categorization of pathogens according to hazard and categories of containment, Second Edition, 1990 1 produced by the Advisory Committee on Dangerous Pathogens,

29、 and published by HMSO. 3) Located at the National Physical Laboratory, Queens Road, Teddington, Middlesex TW 11 OLWBS2646-5:1993 2 BSI 01-1999 Section 1 1.4.4 Test pressure gauges Bourdon tube type test gauges shall be checked for accuracy in accordance with BS 1780:1985. 1.4.5 Test pressure transd

30、ucers Pressure transducers for use with recording instruments shall have a limit of error not exceeding0.2 % when tested in accordance with BS 6253-1:1982 within the range 0 bar to 3 bar 4) . 1.4.6 Temperature sensors 1.4.6.1 Sensor leads shall each be not less than twice the length of a horizontall

31、y mounted autoclave chamber (or the height of a vertically mounted autoclave chamber). 1.4.6.2 Thermocouple leads and sensors shall either conform to those requirements of BS 4937-5:1974 that relate to Tolerance class 1 (Type T), or to those requirements of BS 4937-4:1973 that relate to Tolerance cl

32、ass 1 (Type K). 1.4.6.3 Leads shall be twin core, single strand, twisted, unsheathed with a conductor diameter of0.2 mm to 0.5 mm. 1.4.6.4 Thermocouple hot junctions shall be arc welded or the wires shall be cleaned and twisted together. NOTE 1Twisting conductors together may produce an unreliable j

33、unction. NOTE 2Sensors are introduced into the autoclave chamber through a pressure-tight fitting directly connected to the R p threaded entry (see 11.6.4.3 of BS 2646-1:1993). 1.4.7 Timers Stopwatches used for timing shall be graduated in0.2 s, with an accuracy over a period of 15 min of1.0 s. 4) 1

34、 bar = 10 5N/m 2= 10 5Pa. Pressures referred to are measured from atmosphere and not on the absolute scale.BS 2646-5:1993 BSI 01-1999 3 Section 2 Section 2. Tests for safe function NOTEThe methods of test described in this section are used to check compliance with the requirements for safety devices

35、 specified in BS 2646-1:1993. 2.1 Safety valves (see 9.2 of BS 2646-1:1993) Gradually increase the pressure in the chamber and/or the generator by using steam, and check that the safety valve(s) lift(s) when the maximum permissible working pressure is reached. 2.2 Tests on door interlocks 2.2.1 Stea

36、m to chamber (See item a) of 9.4.2.1 of BS 2646-1:1993 and item a) of 9.4.2.2) With the door closed but not locked, check that steam does not enter the chamber when a cycle is initiated. 2.2.2 Door remains in position (quick-opening doors) (see 9.4.2.1 of BS 2646-1:1993) In turn disable each of the

37、service(s) used to power the door movement as follows: a) during each stage of a cycle; b) whilst the door is opening and closing; c) whilst the door is stationary between cycles. In each case check that the door stops moving or remains stationary. 2.2.3 Interlock switches (quick-opening doors) (see

38、 item h) of 9.4.2.1 of BS 2646-1:1993) Check that moving parts of switches have a positive movement as the door closes and is secured. 2.2.4 Thermal door interlocks (see 9.5.1 ofBS2646-1:1993) Where a thermal door interlock is fitted, check that the door securing mechanism is not released until the

39、load has cooled to the set temperature. 2.3 Tests on discharge of chamber contents (see 9.5.2 of BS 2646-1:1993) With all services connected, disable each service in turn and check that steam, vapour or fluid does not escape from the chamber during a cycle. 2.4 Tests on double door autoclaves For au

40、toclaves with two doors, check each door for compliance with the tests given in 2.2 above. In addition, after a fault (see 1.3.30 of BS 2646-1:1993), check that the unloading door cannot be released at the end of the cycle.BS2646-5:1993 4 BSI 01-1999 Section 3 Section 3. Tests for performance 3.1 In

41、strument accuracy, steady state and operating cycle controls: performance tests 3.1.1 Apparatus and materials Test recorder, which shall have the characteristics listed in 1.4.3.1, with three input channels, each connected to a theromocouple lead and sensor, which shall meet the requirements listed

42、in 1.4.6. 3.1.2 Preparation for the test If a load temperature probe is fitted, place it in the chamber, either in a pocket provided for the purpose or on the load support. Position the two or three thermocouples, as applicable, as follows: a) in the chamber drain (or vent), within 100 mm of its con

43、nection to the chamber; b) in the upper half of the chamber; c) attached to the load temperature probe, if fitted, within 20 mm of its tip. Ensure that thermocouple junctions are suspended and are not in contact with any surface. Set the autoclave controller to produce a sterilizing temperature of b

44、etween 121C and 124C for15min. If such a range is not provided, the nearest temperature to that range shall be used. 3.1.3 Test procedure Operate the autoclave in accordance with the manufacturers instructions for a complete operating cycle. During each stage of the operating cycle: a) monitor the t

45、emperatures recorded by the test recorder; b) monitor and record the autoclave instrument readings; c) measure, independently of the autoclave controller, and record: 1) the duration of the holding time; 2) the operating cycle time. 3.1.4 Test result The accuracy of the autoclave instruments shall b

46、e demonstrated to be within the limits specified in BS 2646-1:1993, by checking against the test recorder. 3.2 Liquids sterilization: performance test (see 12.1 of BS 2646-1:1993) 3.2.1 General The test measures the performance of the autoclave when processing a standard challenge load of bottled li

47、quid. Performance is measured in respect of the following. a) Temperature distribution within the load. b) Ability to maintain the selected temperature for the set time. c) Volume changes in the liquid being processed, whether arising from loss of water vapour or as a result of boiling over. d) The

48、rate of breakage of the specified glass bottles. e) Overall time taken to complete one operating cycle. f) The effectiveness of the thermal door interlocks. 3.2.2 Apparatus and materials 3.2.2.1 Test recorder(s), in accordance with 1.4.3, with twelve input channels each connected to a thermocouple l

49、ead and sensor in accordance with1.4.6. 3.2.2.2 Test containers, comprising glass bottles of nominal capacity 500 ml conforming toBS5928:1980, with a screw neck of thread conforming to DIN 168-1:1979 2. 3.2.2.3 Closures, being plastics caps made from inert, heat-resistant material moulded to a thread suitable for the test containers. 3.2.2.4 Test liquid, comprising bile-salt/agar (MacConkey Agar) solution containing 5 g/l bile salt and 12 g/l agar powder, dissolved in distilled water 5) . 3.2.2.5 Challenge load, comprising N test container