SANS 40-2009 Manually operated medium-vacuum sterilizers (autoclaves)《人工操作中等真空灭菌器（高压灭菌器）》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22714-2 SANS 40:2009Edition 2.3Any reference to SABS 40 is deemedto be a reference to this standard(Government Notice No. 1373 of 8 Novemb

4、er 2002)SOUTH AFRICAN NATIONAL STANDARD Manually operated medium-vacuum sterilizers (autoclaves) Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 40:2009 Edition 2.3 Table of changes Cha

5、nge No. Date Scope Amdt 1 1975 The requirements for the door ring of sliding doors, the centre line height from the floor of doors, the graduations on pressure gauges, and the finish on frames have been amended. Amdt 2 1977 The requirements for the thickness of the aluminium casing for the thermal i

6、nsulating material and for the maximum overall length of sterilizers with a rectangular chamber have been amended. Amdt 3 2009 Amended to change the designation of SABS standards to SANS standards, to delete reference to national legislation from the text, to update the definition of “acceptable“ an

7、d referenced standards, and to change requirements for steel tubes and for paint, as well as for language markings on operating controls, in instruction booklets and on sterilizers. Foreword This South African standard was approved by National Committee SABS TC 1048, Hospital equipment and supplies,

8、 in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in August 2009. This document supersedes SABS 40:1973 (edition 2, as amended by amdt 1:1975 and amdt 2:1977). A reference is made in Note (a) of 1.1 to regu

9、lations covering pressure vessels framed under “the current relevant national legislation“. In South Africa this means the Factories, Machinery and Building Work Act, 1941 (Act No. 22 of 1941). A reference is made in 6.12.1 to compliance of all electrical equipment with requirements of relevant spec

10、ifications declared under “the current relevant national legislation“. In South Africa this means the Standards Act, 1962 (Act No. 33 of 1962). A vertical line in the margin shows where the text has been technically modified by amendment No. 3. SANS 40:2009 Edition 2.3 1 Contents Page Foreword 1 Sco

11、pe . 3 2 Definitions 3 3 Types . 3 4 Operating requirements . 4 5 Materials . 4 6 Constructional requirements 6 6.1 General 6 6.2 Welds on non-pressure parts 6 6.3 Sterilizing chamber 6 6.4 Door rings 8 6.5 Doors . 8 6.6 Door joints . 9 6.7 Steam jacket . 9 6.8 Thermal insulation . 9 6.9 Fittings .

12、9 6.10 Accessories . 12 6.11 Nickel-plating . 12 6.12 Electrical equipment 13 6.13 Instruction booklets . 13 7 Marking 14 8 Sampling and compliance with the specification . 14 9 Inspection and methods of test 14 9.1 Inspection 14 9.2 Operational tests on sterilizers 14 9.3 Tests on electrical equipm

13、ent . 15 Appendix A Applicable standards 17 Appendix B Notes to purchasers . 18 SANS 40:2009 Edition 2.3 2 This page is intentionally left blank SANS 40:2009 Edition 2.3 3 Manually operated medium-vacuum sterilizers (autoclaves) 1 Scope 1.1 This specification covers dimensional, constructional, and

14、safety requirements for steam- and electrically heated, manually operated medium-vacuum sterilizers (autoclaves) for use in hospitals and other medical institutions. NOTE a) The manufacture of the sterilizing chamber and the steam jacket and, where relevant, the steam generator of all pressure-type

15、sterilizers is governed by regulations covering pressure vessels framed under the current relevant national legislation (see foreword), and the manufacture of the steam generator, if a separate unit, is governed by Regulations C90 C112 of this Act. Amdt 3 The specification does not purport to supers

16、ede or overrule any of the requirements laid down in the Act. b) The standards referred to in the specification are listed in appendix A. c) Requirements that must be specified by the purchaser and those that must be agreed upon between supplier and purchaser are listed in appendix B. 2 Definitions

17、2.1 For the purposes of this specification the following definitions shall apply: acceptable acceptable to the authority administering this specification, or to the parties concluding the purchase contract, as relevant Amdt 3 defective sterilizer that fails in one or more respects to comply with the

18、 appropriate requirements of the specification lot not more than 20 sterilizers of the same type and size, from one manufacturer, submitted at any one time for inspection and testing 3 Types 3.1 The sterilizers shall be of the following types: Type A. Sterilizers operating with steam from an indepen

19、dent source. Type B. Sterilizers operating with steam generated in a built-in electric steam generator. SANS 40:2009 Edition 2.3 4 3.2 The sterilizers shall consist of a horizontal steam-jacketed autoclave having an inner sterilizing chamber of cylindrical cross-section in the case of sizes b, c, d,

20、 e, and f, and in the case of size a (see table 2) of cylindrical or rectangular cross-sections, as specified by the purchaser. The sterilizing chamber shall have a door at one end. The steam jacket shall be enclosed in an insulated casing. Sterilizers shall be provided with all necessary controls a

21、nd instruments, and shall be mounted on an open steel frame, or enclosed in a cabinet, or built in, as specified by the purchaser. If the sterilizer is to be built-in, it shall be provided with a suitable panel (to close the front of the recess), as required by the purchaser. The overall dimensions

22、of the sterilizer shall not exceed the appropriate values given in columns 7 12 (inclusive) of table 2. 4 Operating requirements 4.1 The sterilizers shall be capable of operating at a temperature of up to 138 C and a pressure of up to 240 kPa (gauge) using saturated dry steam, supplied in the case o

23、f type A sterilizers, at a pressure of not less than 280 kPa and not more than 410 kPa (gauge). When so required by the purchaser, a pressure selector shall be provided to enable the sterilizer to be operated at either of two predetermined pressures. 4.2 4.2.1 Unless otherwise specified by the purch

24、aser, type A sterilizers shall have an ejector that is capable of producing and maintaining a vacuum corresponding to an absolute pressure of 27 kPa (i.e. a vacuum of -74 kPa at sea level). Type B sterilizers shall have a vacuum pump or a water- or a steam-operated ejector that is capable of produci

25、ng and maintaining a vacuum corresponding to an absolute pressure of 50 kPa (i.e. a vacuum of -51 kPa at sea level) and when the chamber is empty this vacuum shall be attained in not more than 5 min (see also footnote 6). 4.2.2 In type A sterilizers required by the purchaser (see 4.2.1) to be fitted

26、 with a vacuum pump, the vacuum shall be drawn by means of an electrically driven water-seal pump, with a condenser fitted between the chamber and the pump. The vacuum thus drawn shall correspond to an absolute pressure of not more than 15 kPa (i.e. a vacuum of at least -86 kPa at sea level) and whe

27、n the chamber is empty this vacuum shall be attained in not more than 5 min (see also footnote 6). 4.3 The mechanical and electrical controls shall be manually operated and shall permit one of the following complete cycles of sterilization: a) Admission of steam, evacuation of steam and air, second

28、admission of steam to give a pre-selected temperature, sterilizing for the appropriate time, exhausting of steam, drying by vacuum, and breaking of vacuum with filtered air, b) admission of steam, drawing of vacuum while a controlled flow of steam enters the sterilizing chamber to flush out the air,

29、 admission of steam to give a pre-selected temperature, sterilizing for the appropriate time, exhausting of steam, drying by vacuum, and breaking of vacuum with filtered air. 4.4 In the case of type B sterilizers, the heating time and the kilowatt loading shall be in accordance with the appropriate

30、values in columns 13 and 14 of table 2. 5 Materials 5.1 General Components that are joined or are used as fasteners (e.g. rivets, bolts, nuts, hinges, and fittings) shall be made of material that is such that electrolytic corrosion will not occur between the abutting surfaces. All materials used for

31、 welding shall have mechanical properties and corrosion and erosion SANS 40:2009 Edition 2.3 5 resistance of at least the same order as those of the parent metal. Thermal insulating material shall not deteriorate in use and shall not cause corrosion of any part of the sterilizer with which it is in

32、contact. 5.2 Sterilizing chamber, steam jacket, door, and door ring The materials used for the sterilizing chamber, the steam jacket, the door, and the door ring shall be in accordance with one of the combinations given in table 1. The quality of the materials shall be as laid down in the code of pr

33、actice for the construction of pressure vessels approved by the Chief Inspector of Factories or other statutory authority. Table 1 Materials 1 2 3 4 Chamber Jacket Door ring Door Stainless steel Stainless steel a) Forged steel, b) gun-metal, or c) stainless steel a) Mild steel, stainless-steel-clad

34、on internal face, b) gun-metal, or c) stainless steel Stainless-steel-clad mild steel Mild steel a) Forged steel, b) gun-metal, or c) stainless steel a) Mild steel, stainless-steel-clad on internal face, or b) gun-metal Nickel-clad mild steel Mild steel a) Forged steel, b) gun-metal, or c) copper ni

35、ckel alloy a) Mild steel, nickel-clad on internal face, b) gun-metal, or c) copper nickel alloy Mild steel (with or with- out a stainless steel liner) Mild steel a) Mild steel, b) forged steel, or c) gun-metal a) Mild steel, b) gun-metal, or c) mild steel with or without a stainless steel liner Copp

36、er Copper Gun-metal casting a) Gun-metal casting, or b) mild steel, copper-lined on internal face 5.3 Non-pressure parts 5.3.1 Mild steel sheet and angle sections Mild steel sheet and angle sections shall be of acceptable quality. 5.3.2 Steel tubes Steel tubes used in the framework shall comply with

37、 the requirements for grade 230 or grade 250 of SANS 657-4. Amdt 3 5.3.3 Castings and forgings Castings and forgings shall be free from cracks, blowholes, and other defects. 5.3.4 Paint Paint used on mounting stands and frames (see 6.9.12) shall be an enamel or a system comprising a primer and an en

38、amel. Amdt 3 SANS 40:2009 Edition 2.3 6 6 Constructional requirements 6.1 General The sterilizing chamber, the steam jacket, and, in the case of type B sterilizers, the steam generator shall be made in accordance with the requirements of a code of practice approved by the Chief Inspector of Factorie

39、s or other appropriate statutory authority. 6.2 Welds on non-pressure parts Fusion welds shall be acceptable and shall have mechanical properties and corrosion resistance of at least the same order as those of the parent metal. The weld faces shall be smooth and clean. Spot welds shall be resistance

40、 spot welds and there shall be proper fusion between the parts welded. The spots shall be spaced sufficiently close together to produce a strong joint. The indentation produced by the electrode on the outer (visible) side of a joint shall be minimal. NOTE Requirements for welds on the pressure parts

41、 are covered in the code of practice for the construction of pressure vessels in accordance with which the sterilizer is made. 6.3 Sterilizing chamber 6.3.1 Dimensions The inside dimensions of the sterilizing chamber shall conform to the values given in columns 2 6 (inclusive) of table 2, appropriat

42、e to the size designation specified by the purchaser. Table 2 Dimensions for sterilizers 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Dimensions mm Sterilizing chamber Overall size of sterilizers Cylindrical Rectangular With cylindrical chamber With rectangular chamber Size designationInside diameter+ Inside le

43、ngth+ Inside height+ Inside length+ Inside width+ Height max. Length max. Width max. Height max. Length max. Width max. Time (in minutes) taken from cold to get type B sterilizer ready to start sterilizing cycle max.*Loading of steam generators of type B sterilizers kW max. a 405 610 460 760 460 1 7

44、80 1 070 740 1 780 1 300 740 45 9 b 405 760 1 780 1 070 740 50 9 c 460 610 1 780 1 070 740 50 12d 460 760 1 780 1 070 740 50 12 e 460 915 1 780 1 200 740 50 12 f 510 915 1 780 1 200 740 50 12 * Except that where the local power supply is not capable of maintaining the maximum loading (see column 14)

45、, the heating time shall be as agreed upon between supplier and purchaser. The specified times apply to supply water at 21 C. +Subject to a tolerance of 6 mm. Amdt 2 7 SANS 40:2009 Edition 2.3 SANS 40:2009 Edition 2.3 8 6.3.2 Design The design shall be such that condensate cannot fall on to a load i

46、n the sterilizer. The steam inlet shall be in the centre of the back of the chamber and there shall be a condensate drain in the lowest part of the front of the chamber. This drain (which also serves as an exhaust) shall be fitted with a removable strainer and the inlet to the drain shall be recesse

47、d. The chamber shall be so mounted as to slope slightly towards the drain. The rear inner wall shall be fitted with a steam baffle that provides a steam space of width at least 5 mm. The clear distance between the outer edge(s) of the baffle and the inner surface of the chamber shall not exceed 65 m

48、m. The bottom of the chamber shall be provided with a stainless steel shelf of light construction, suitably reinforced, and so designed as to keep the load clear of the bottom of the chamber, drain condensate away to the sides or rear (clear of the load), and permit the access of steam to all parts

49、of the chamber. In the case of type B sterilizers, the outlet in the jacket (for condensate) shall drain directly back into the steam generator; the piping shall be as short as possible and shall have a slope of at least 45. An automatic air vent shall be fitted to the jacket in such a position that it will discharge the maximum volume of air when steam is admitted. All pipe work shall be so arranged as to facilitate maintenance. 6.4 Door rings The door ring shall be welded to the body of the chamber and shall inco