SANS 982-2009 High-pressure high-vacuum steam sterilizers (autoclaves)《高压高真空蒸汽灭菌器（高压锅）》.pdf

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 978-0-626-23408-9 SANS 982:2009Edition 3.1Any reference to SABS 982 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 high-vacuum steam 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 982:2009 Edition 3.1 Table of chang

5、es Change No. Date Scope Amdt 1 2009 Amended to change the designation of SABS standards to SANS standards, to delete the reference to national legislation from the text, to update language marking requirements on operating controls, on double doors and on instruction booklets, to update referenced

6、standards, to delete a footnote regarding the obtainability of suitable autoclave indicator tape from the SABS, to update the quality verification appendix (appendix C), and to add a bibliography. Foreword This South African standard was approved by National Committee SABS TC 1048, Hospital equipmen

7、t and supplies, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement This document was published in September 2009. This document supersedes SABS 982:1990 (edition 3). A reference is made in NOTE (a) to 1.1 and in a NOTE to 5.7.4 to regula

8、tions governing pressure vessels and boilers promulgated in terms of “the current relevant national legislation“. In South Africa this means the Factories, Machinery and Building Work Act, 1941 (Act No. 22 of 1941). A vertical line in the margin shows where the text has been technically modified by

9、amendment No. 1. SANS 982:2009 Edition 3.1 1 Contents Page Foreword 1 Scope 3 2 Definitions . 3 3 Types 4 4 Functional requirements . 4 5 Constructional requirements . 7 6 Electrical equipment (general) and steam generator (type B sterilizers only) . 11 7 Marking and instructions 12 8 Inspection and

10、 methods of test 13 8.1 Inspection 13 8.2 Test sequence 13 8.3 Automatic operation tests . 13 8.4 Air removal test . 14 8.5 Leak test 14 8.6 Sterility test (Bowie and Dick autoclave tape test) 14 8.7 Tests on electrical equipment (type B sterilizers only) 16 Appendix A Applicable standards . 17 Appe

11、ndix B Notes to purchasers 17 Appendix C Quality verification of sterilizers 18 Amdt 1 Bibliography . 18 Amdt 1 SANS 982:2009 Edition 3.1 2 This page is intentionally left blank SANS 982:2009 Edition 3.1 3 High-pressure high-vacuum steam sterilizers (autoclaves) 1 Scope 1.1 This specification covers

12、 functional and constructional requirements for automatic sterilizers (vacuum and steam type) that may be used in hospitals, in conjunction with an independent or a dedicated steam supply, for sterilizing unwrapped utensils, instruments, hollow ware, wrapped goods (packs), porous loads and, when so

13、required (by special modification to the sterilizer), fluids. NOTE a) The manufacture of 1) the sterilizing chamber; 2) the steam jacket of pressure-type sterilizers; and 3) the steam generator of a sterilizer having a dedicated steam supply is governed by regulations covering pressure vessels and b

14、oilers, as relevant, promulgated in terms of the current relevant national legislation (see foreword). The specification does not purport to supersede or overrule any of the requirements laid down in the Act. Amdt 1b) The standards referred to in the specification are listed in appendix A. c) Requir

15、ements that must be specified by the purchaser and information that should be sought from the supplier are given in appendix B. d) Guidance on the verification of the quality of sterilizers is given in appendix C. 2 Definitions 2.1 For the purposes of this specification the following definitions sha

16、ll apply: absolute pressure pressure measured from absolute vacuum chamber that part of the sterilizer that accommodates the items undergoing sterilization cycle the operating cycle SANS 982:2009 Edition 3.1 4 gauge pressure pressure measured from ambient atmospheric pressure high vacuum descriptive

17、 of an absolute pressure not exceeding 20 kPa 3 Types 3.1 The sterilizers shall be of the following types: Type A Sterilizers operating with steam from an independent source. Type B Sterilizers operating with steam generated in a built-in electric steam generator. 4 Functional requirements 4.1 Steam

18、 control and pressure 4.1.1 Pressure reducing valve A sterilizer shall be provided with a pressure reducing valve or an equivalent device to enable the required steam pressure in the chamber and jacket to be maintained. 4.1.2 Steam separator When the sterilizer chamber steam is not drawn from the st

19、eam jacket, a steam separator (to remove steam condensate) shall be fitted on the inlet steam side of the steam circuit before the pressure reducing valve is fitted. 4.1.3 Operating steam pressure The chamber and jacket of a sterilizer shall be capable of operating at an internal gauge pressure of a

20、t least 240 kPa. 4.2 Air removal system A sterilizer shall have an air removal system such that, when the sterilizer is tested in accordance with 8.4, the pressure in the unloaded chamber is reduced, within 3 min, from ambient atmospheric pressure (i.e. zero gauge pressure) to an absolute pressure n

21、ot exceeding 20 kPa (which may be taken to be a gauge pressure of 80 kPa at sea level). 4.3 Operator controls 4.3.1 General All controls shall be clearly visible and clearly and permanently marked in at least English or, in the case of valve controls and microprocessors, by symbols, to indicate thei

22、r function. Where necessary, the controls shall be suitably extended to a position where they are readily accessible to the operator. Amdt 1 SANS 982:2009 Edition 3.1 5 4.3.2 Handles and handwheels When a sterilizer is tested in accordance with 8.3.3(a), the surface temperature of handles and handwh

23、eels shall not exceed 50 C. 4.4 Cycle and stage controls 4.4.1 Automatic control A sterilizer shall be so designed that once an operating cycle is started on automatic mode, it is completed automatically. 4.4.2 Operating cycle An operating cycle shall consist of the following stages: a) Preliminary

24、stage (for type B sterilizers only) The electric steam generator shall build up steam pressure to a regulated pressure of 240 kPa. b) Stage 1 Air removal Repeated cycles (pulses) of admission of steam into the chamber and evacuation of steam and air from the chamber (using the air removal system) to

25、 remove sufficient air from the chamber and its load to allow the continuing sterilization process to be effective. c) Stage 2 Steam admission Admission of steam into the chamber to achieve the pre-selected sterilization temperature in the range 134 C 138 C. d) Stage 3 Sterilization Maintaining the

26、sterilization temperature in the chamber for a minimum period of 4 min. e) Stage 4 Drying Drying the load by subjecting it to an absolute pressure not exceeding 20 kPa and to radiated heat (from the walls of the chamber heated by the steam jacket) for a minimum period of 4 min. f) Stage 5 Air admiss

27、ion Admission of filtered air into the chamber to bring it up to atmospheric pressure. 4.4.3 Stage control settings It shall be possible to adjust the settings (pre-select) in the automatic control cycle, for the following: a) The number of pulses in stage 1 (with a minimum of 4 pulses); b) the temp

28、erature and pressure of the sterilization stage; c) the duration of the sterilization stage (with a minimum time period of 4 min, and a maximum of at least 20 min); and d) the duration of the drying stage. SANS 982:2009 Edition 3.1 6 4.4.4 Conversion to fluid sterilization When so required, a steril

29、izer shall be capable of being switched over for the sterilization of fluids on the downdraught principle. The sterilization temperature shall be at least 120 C and shall be maintained for at least 30 min. 4.4.5 Manual control When so required, a sterilizer shall be fitted with a manually operated c

30、ontrol that can override the automatic control and with which it is possible to carry out a complete operating cycle. 4.4.6 Cycle progress indicators Indicators shall be installed in a prominent position to indicate the stage of the operating cycle reached, and to indicate the completion of the cycl

31、e. 4.4.7 Indication of sterilization failure 4.4.7.1 If a sterilizer fails to fulfil the conditions (see 4.4.7.2) required for sterilization, the sterilizer shall a) illuminate a visual display with the words “NON-STERILE“; b) sound an audible alarm; and c) complete the automatic cycle. 4.4.7.2 A st

32、erilizer shall react as given in 4.4.7.1(a) (c) if, a) in the case of a sterilizer with a chamber of size not exceeding 0,50 m3, the sterilizing temperature is not achieved within 6 min of the start of stage 2 or is not maintained during stage 3 of the operating cycle (see 4.4.2); and b) in the case

33、 of a sterilizer with a chamber of size exceeding 0,50 m3, the sterilizing temperature is not achieved during stage 2 (within a pre-selected period) or is not maintained during stage 3 of the operating cycle. 4.4.8 Leak test facility1)a) A sterilizer shall include an automatic leak test control such

34、 that when the control is set to the “test“ position and stage 4 (drying stage) of the operating cycle is reached (see 4.4.2), the chamber is automatically isolated and the vacuum pump stopped. b) Provision shall be made on the chamber for the connection of an absolute pressure gauge to indicate the

35、 internal pressure in the chamber. The connection shall be of such design that when an absolute pressure gauge is fitted, the gauge is automatically isolated at all times except during the static vacuum phase described in (a) above. c) When a sterilizer is tested in accordance with 8.5, the increase

36、 in the chamber pressure recorded over a 10 min period shall not exceed 1 330 Pa. 1) A leak test should be carried out by a suitably trained technician only. SANS 982:2009 Edition 3.1 7 4.5 Sterilizing efficiency When a sterilizer is tested in accordance with 8.6, a) the duration of the operating cy

37、cle shall not exceed 20 min (excluding the preliminary stage for a type B sterilizer (see 4.4.2(a); b) the increase in the mass of the test pack shall not exceed 6 %; and c) the indicator tape shall show the same colour change along the length of the tape. NOTE 1) When interpreting the results of th

38、e test, it is important to place the end of the test tape adjacent to its centre in order to make a direct comparison of the colour of the tape at the edge and in the centre of the test pack. 2) If there is any discernible difference in the colour change along the tape, record the sterilizer as havi

39、ng failed the test. 5 Constructional requirements 5.1 General a) A sterilizer shall have a horizontal chamber of circular or rectangular cross-section (see 5.2). The chamber (excluding the door(s) shall be surrounded by a steam jacket with a minimum steam space of 15 mm at all points (i.e. measured

40、between the steam-jacket shell and the chamber). b) The design of the chamber shall be such that condensate is not likely to fall or to be sprayed (with the incoming steam) onto a load in the chamber. c) The chamber walls shall be smooth enough to facilitate cleaning. d) The chamber floor shall slop

41、e slightly towards a drain hole, which shall be recessed and of diameter at least 20 mm. e) The sterilizer shall be mounted on an open steel frame or enclosed in a cabinet or designed to be built in, as required. If the sterilizer is to be built in, it shall be provided with a suitable panel and arc

42、hitrave to close the recess. 5.2 Size The minimum size and the shape (either cylindrical or rectangular) of the inside of the chamber shall be as required. 5.3 Doors 5.3.1 Provision of doors A door shall be provided at one end or at both ends of the chamber, as required. 5.3.2 Double doors A sterili

43、zer fitted with a door at both ends of the chamber shall be such as to permit operation only SANS 982:2009 Edition 3.1 8 when both doors are closed and locked. A visual display with the words “doors locked“ shall illuminate at both ends of the sterilizer when both doors are closed and locked. Amdt 1

44、5.3.3 Door interlocks All door opening and closing mechanisms shall be such that a) steam is prevented from entering the chamber before the door is completely closed and locked; b) a power-operated door will not close or will stop closing if obstructed; c) a closed and locked door can be safely and

45、easily opened by manual operation if the power fails during any phase of the operating cycle. 5.3.4 Door gaskets Doors shall be fitted with pressure sealing gaskets of silicon rubber. 5.4 Thermal insulation The exterior of the steam jacket shall be lagged with thermal insulating material of such des

46、ign that the rate of heat transfer through the lagging does not exceed 1,75 W/(m2K). Where practicable, steam supply pipes shall be lagged in a similar manner. The insulation shall be easily removable and replaceable for the inspection of the unit. Condensate pipes and vent pipes shall not be lagged

47、. 5.5 Thermostatic steam trap and steam/condensate discharge The drain from the sterilizer chamber shall be piped through a dedicated non-return valve and balanced thermostatic steam trap. The drain from the steam jacket shall be piped to a dedicated balanced thermostatic steam trap. NOTE A non-retu

48、rn valve shall not be fitted between the steam jacket and the thermostatic steam trap. Where the vacuum pump runs continuously for the full duration of the cycle (continuous vacuum system), the chamber drain may be connected into the air removal system. The traps shall be of the near-to-steam type,

49、capable of passing the air and condensate expelled from the chamber, and closing against steam. The steam traps shall be intended for working at any gauge pressure in the range 100 kPa 275 kPa and shall be designed to start to open before the temperature difference between the condensate and the saturated steam at the same pressure exceeds 6 C. All steam shall be condensed before being discharged from the sterilizer. 5.6 Air filter Air introduced into a chamber following a vacuum condition in the chamber shall be filtered. The air filter shall a) include