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 978-0-626-22713-5 SANS 981:2009Edition 2.3Any reference to SABS 981 is deemed to be a reference to this standard (Government Notice No. 1373 of 8 No
4、vember 2002) SOUTH AFRICAN NATIONAL STANDARD High-pressure down-draught steam sterilizers (autoclaves) (with independent steam supply) 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 98
5、1:2009 Edition 2.3 Table of changes Change No. Date Scope Amdt 1 1975 The requirements for the centre line height from the floor of doors, the door ring of sliding doors, the graduations on pressure gauges, and the finish on frames have been amended. Amdt 2 1977 The requirement for the thickness of
6、the aluminium casing for the thermal insulating material of sterilizers has been amended. Amdt 3 2009 Amended to change the designation of SABS standards to SANS standards, to delete the reference to national legislation from the text, to update referenced standards and the definition of “acceptable
7、“, to change requirements for steel tubes and for paint, and to change language marking requirements for sterilizers, operating controls and instruction booklets. Foreword This South African standard was approved by National Committee SABS TC 1048, Hospital equipment and supplies, in accordance with
8、 procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement This document was published in June 2009. This document supersedes SABS 981:1973 (edition 2 as modified by amdt 1:1975 and amdt 2:1977). A reference is made in 1.1 NOTE (a) to regulations governing pressu
9、re 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 5.11 to the compliance of electrical equipment with the requirements of the relevant specifications declar
10、ed 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 981:2009 Edition 2.3 1 Contents Page Foreword 1 Scope. 3 2 Definiti
11、ons 3 3 Operating requirements . 4 4 Materials. 4 5 Constructional requirements 5 6 Marking . 10 7 Sampling and compliance with the specification 10 8 Inspection and methods of test. 11 8.1 Inspection. 11 8.2 Methods of test 11 Appendix A Applicable standards 12 Appendix B Notes to purchasers. 13 SA
12、NS 981:2009 Edition 2.3 2 This page is intentionally left blank SANS 981:2009 Edition 2.3 3 High-pressure down-draught steam sterilizers (autoclaves) (with independent steam supply) 1 Scope 1.1 This specification covers dimensional, constructional, and safety requirements for high-pressure down-drau
13、ght automatic steam sterilizers (autoclaves) of the horizontal rectangular or cylindrical type for the sterilization of unwrapped instruments and utensils in hospitals and other institutions. NOTE a) The manufacture of the sterilizing chamber of all pressure-type sterilizers is governed by regulatio
14、ns covering pressure vessels framed under the current relevant national legislation (see foreword). Amdt 3 The specification does not purport to supersede or overrule any of the requirements laid down in the Act. b) Sterilizers made to this specification should not be installed in zones of risk asso
15、ciated with the use of flammable anaesthetics unless special precautions are taken in respect of the explosion-proofness of electrical equipment. Amdt 3 c) The titles of standards referred to by number in the specification are given in appendix A. d) Requirements that must be specified by the purcha
16、ser and those that must be agreed upon between supplier and purchaser are listed in appendix B. 2 Definitions 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 pu
17、rchase contract, as relevant Amdt 3 defective sterilizer that fails in one or more respects to comply with the appropriate requirements of the specification lot not more than 20 sterilizers of the same size and construction, from one manufacturer, submitted at any one time for inspection and testing
18、 SANS 981:2009 Edition 2.3 4 3 Operating requirements 3.1 Unless otherwise specified by the purchaser, the sterilizers shall be capable of operating at a temperature of up to 138 C and at a pressure of 240 kPa (gauge), using saturated dry steam supplied at a pressure of not less than 275 kPa and not
19、 more than 420 kPa (gauge) from an independent source. 3.2 The mechanical and electrical controls shall be automatically operated and shall permit the following complete cycle of sterilization: Expulsion of air by the admission of steam, raising of steam pressure to give the pre-set temperature, mai
20、ntaining of steam pressure for the pre-set sterilizing time, exhausting of steam. A separate manually operated valve, and an air filter, shall be fitted to the sterilizer to relieve any vacuum that may form within the chamber. The sterilizer shall also be fitted with a separate manually operated con
21、trol to enable a complete cycle of sterilization to be carried out. 4 Materials 4.1 General Components that are joined or are used as fasteners (e.g. rivets, bolts, nuts, hinges, and fittings) or any other components shall be made of material, that is such that electrolytic corrosion will not occur
22、between abutting surfaces. All materials used for welding shall have mechanical properties and corrosion and erosion 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 sterilize
23、r with which it is in contact. 4.2 Sterilizing chamber, door, and door ring The material used for the chamber, the door, and the door ring shall be in accordance with one of the combinations given in table 1. The quality of the materials and the construction of the sterilizing chamber shall be as la
24、id down in the code of practice for the construction of pressure vessels approved by the Chief Inspector of Factories or other appropriate statutory authority. Table 1 Materials I 2 3 Chamber Door ring Door Stainless steel a) Gun-metal, or b) stainless steel a) Gun-metal, or b) stainless steel Nicke
25、l-clad mild steel a) Mild steel, b) gun-metal, or c) copper nickel alloy a) Mild steel, nickel-clad on internal face, b) gun-metal, or c) copper nickel alloy SANS 981:2009 Edition 2.3 5 4.3 Non-pressure parts 4.3.1 Mild steel sheet and angle sections Mild steel sheet and angle sections shall be of a
26、cceptable quality. 4.3.2 Steel tubes Steel tubes used in the framework shall comply with the requirements for grade 230 or grade 250 of SANS 657-4. Amdt 3 4.3.3 Castings and forgings Castings and forgings shall be free from cracks, blowholes, and other defects. 4.3.4 Paint Paint used on mounting sta
27、nds shall be an enamel or a system comprising a primer and an enamel. Amdt 3 4.3.5 Stainless steel for trays, bottle racks, and supports The stainless steel used for trays, bottle racks, supports and, when relevant, shelves and loading carriages (see 5.9.2) shall comply with the requirements for AIS
28、I Type 316, 321, or 304L steel. 5 Constructional requirements 5.1 General The sterilizer shall have a horizontal sterilizing chamber of cylindrical or rectangular cross-section, as specified by the purchaser, having a door at one end or a door at each end, as specified by the purchaser. The chamber
29、shall be enclosed in an insulated casing. The sterilizer shall be provided with all necessary controls and 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 s
30、uitable panel to close the front of the recess, as specified by the purchaser. Unless otherwise specified by the purchaser, the height of the centre line of the door at the front of the sterilizer, when closed, shall be 1 070 25 mm from the floor, and the overall dimensions of the sterilizer shall n
31、ot exceed the values given in columns 6 11 (inclusive) of table 2, appropriate to the size of chamber specified by the purchaser. Amdt 1 Sterilizing chambers having a door at each end shall be such as to permit operation only when both doors are closed and locked. The operating controls (see 5.8.7)
32、shall be operable from one end only. An illuminated indicating device shall be provided at each end of the sterilizer, indicating “doors locked“ (in at least English) when both doors are closed and locked. Electric lamps used for this purpose shall be wired in series. Amdt 3 5.2 Welds on non-pressur
33、e 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 spot welds and there shall be proper fusion between the parts welde
34、d. 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. SANS 981:2009 Edition 2.3 6 NOTE Requirements for welds on the pressure parts are covered in the code of practice for
35、 the construction of pressure vessels in accordance with which the sterilizer is made. 5.3 Sterilizing chamber 5.3.1 Dimensions The inside dimensions of the sterilizing chamber shall conform to the appropriate set of values given in columns 1 5 (inclusive) of table 2, as specified by the purchaser.
36、Table 2 Dimensions for sterilizers 1 2 3 4 5 6 7 8 9 10 11 Dimensions mm Sterilizing chamber Overall size of sterilizers Cylindrical Rectangular With cylindrical chamber With rectangular chamber Inside diameter* Inside length* Inside height* Inside length* Inside width* Height max. Length max. Width
37、max. Height max. Length max. Widthmax. 305 510 405 610 405 1 780 690 610 1 780 1 070 740 405 610 460 610 460 1 780 915 735 1 780 1 070 740 455 610 1 780 915 735 455 760 1 780 1 070 735 * Subject to a tolerance of 6 mm. 5.3.2 Design The design shall be such that condensate cannot fall on to a load in
38、 the chamber. The steam inlet shall be in the centre of the back of the chamber except that in the case of sterilizing chambers having a door at each end, it shall be at the top of the back. A condensate drain shall be provided in the lowest part of the front of the chamber. This drain (which also s
39、erves as an exhaust) shall be fitted with a removable strainer and the inlet to the drain shall be recessed. The chamber shall be so mounted as to slope slightly downwards towards the drain. In the case of the sterilizing chambers having one door, the rear inner wall shall be fitted with a steam baf
40、fle that provides a steam space of width at least 5 mm. The clear distance between the outer edges of the baffle and the inner surface of the chamber shall not exceed 65 mm. 5.4 Door rings The door ring shall be welded to the body of the chamber and shall incorporate means for deflecting emitted ste
41、am away from the operator. A recessed drain shall be fitted in the lowest part of the door ring. In the case of hinged doors, the door ring shall have acceptable cast-on or separately fitted self-aligning (compensating) hinges to suspend the door. In the case of sliding doors, the door ring shall ha
42、ve acceptable machined grooves or a fabricated groove ring to accommodate the door and the sealing gasket. Amdt 1 SANS 981:2009 Edition 2.3 7 5.5 Doors Doors shall be of the hinged or sliding type. The hinged type shall be fitted with an acceptable hand-operated opening and closing mechanism having
43、a hand wheel or hand levers made of stainless steel, nickel-chromium-plated mild steel, or other acceptable metal. The sliding type shall be fitted with an acceptable power-operated opening and closing mechanism. Door operating fittings normally touched by hand shall be effectively heat insulated. A
44、ll door opening and closing mechanisms shall be such that a) the door cannot be opened while the steam pressure in the sterilizing chamber exceeds the pressure of the atmosphere by more than 15 kPa; b) steam is prevented from entering the chamber before the door is completely closed; c) power-operat
45、ed doors will not close or will stop closing if obstructed; d) a closed sliding door can be safely and easily opened by hand if the power fails during any phase of the sterlizing cycle; e) the steam supply to the chamber is closed off and a ventilation valve simultaneously opened at commencement of
46、the door opening operation; f) they do not permit more than slight opening of the door (cracking of the door seal) until steam has completely escaped; and g) after the steam pressure in the chamber has been reduced to the value specified in (a) above, the force required on the hand wheel or hand lev
47、ers to open the door does not exceed 50 N. 5.6 Door joints 5.6.1 General The joint between the door and the door ring shall be made by a heat-resistant gasket1)of acceptable silicone rubber or other acceptable material. The gasket shall be fitted in such a manner that it does not become displaced or
48、 damaged by the operation of the door. When tested in accordance with 8.2.1, the joint shall not leak under steam pressure. 5.6.2 Position of gaskets Gaskets for hinged doors shall be fitted into the door, and those for sliding doors shall be fitted into the door ring. 5.7 Thermal insulation The ext
49、erior of the sterilizer shall be lagged with acceptable thermal insulating material of such thickness that the coefficient of heat transfer of the insulating layer shall not exceed 1,75 W/m2/C . The insulation shall be covered with a 0,9 mm thick casing of polished aluminium or with an 0,7 mm thick casing of polished stainless steel. Where practicable, steam supply pipes shall be lagged in a similar manner. The insulation shall be easily removable for inspection of the unit. Condensate and air vent pipes need not be lagged. Amdt 2 1)The free unsecured f
