SANS 5730-2009 Antibacterial efficacy of solid and semi-solid antiseptics《固体和半固体防腐剂的抗菌效果》.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-978-0-626-22308-3 SANS 5730:2009 Edition 2SOUTH AFRICAN NATIONAL STANDARD Antibacterial efficacy of solid and semi-solid antiseptics Published by SA

4、BS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001 Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 5730:2009 Edition 2 Table of changes Change No.

5、 Date Scope Foreword This South African standard was approved by National Committee SABS TC 1022, Antiseptics, disinfectants and detergent-disinfectants, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in

6、April 2009. This document supersedes SABS SM 730:1975 (first edition as modified by amdt 1:1977). This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 5730:2009 Edition 2 1Antibacterial efficacy of solid and semi-solid antiseptics 1 Scope The s

7、tandard describes a method to determine the antibacterial efficacy of solid and semi-solid antiseptics. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the

8、latest edition of the referenced document (including any amendments) applies. Information on currently valid national and international standards can be obtained from the SABS Standards Division. SANS 636 (SABS 636), Disinfectants based on quaternary ammonium compounds. 3 General The general require

9、ments laid down for glassware, media, and test organisms in the latest issue of SANS 636 shall apply. Sampling and testing shall be performed aseptically by personnel trained in microbiological techniques. 4 Test organisms and media 4.1 Organisms Staphylococcus aureus Sta 10 ATCC 6538; Escherichia c

10、oli. Esc 20 ATCC 8739; and Pseudomonas aeruginosa Pse 16 ATCC 15442. 4.2 Preparation of test organism suspensions Maintain the test organisms and prepare the cultures for test suspensions as described in SANS 636. Using sterile water as the diluent, prepare suspensions as described in SANS 636, but

11、containing (10 7 10) % living cells per millilitre. This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 5730:2009 Edition 2 2 4.3 Media 4.3.1 Antibiotic medium No.1 Ingredients: agar 15,0 g beef extract 1,5 g glucose 1,0 g pancreatic digest of

12、 casein 4,0 g peptone 6,0 g yeast extract 3,0 g Dissolve the ingredients in approximately 900 mL of water, so adjust the pH value that it will be 6,6 0,05 after sterilization, and dilute to 1 000 mL. Dispense in (20 0,2) mL volumes, and sterilize by autoclaving for (15 0,5) min at (121 2) C. 4.3.2 S

13、terile inactivated horse serum free from preservatives. 5 Procedure 5.1 Melt the contents of a bottle of the antibiotic medium No. 1 (see 4.3.1), and temper to (45 2) C. Add to the melted medium 1 mL of the sterile inactivated horse serum (see 4.3.2) and 1 mL of the S. aureus test organism suspensio

14、n (see 4.2). Mix well, avoiding the formation of air bubbles, pour the mixture into a Petri dish of diameter 90 mm and allow to solidify. 5.2 Using a sterile cutter that produces cylindrical holes of diameter 8 mm, make five evenly- spaced straight cylindrical holes in the medium in the Petri dish.

15、Remove and discard the plugs of medium. Seal the bottom of each hole using two drops of the molten medium (see 4.3.1) and allow to solidify. 5.3 Introduce the test sample into the holes in such a way that each hole is completely filled with the sample, and no air bubbles are formed. When the test sa

16、mple is in tablet, pellet, or granular form, grind, using a sterile pestle and mortar, a sufficient number of tablets, pellets, or granules to a fine powder and introduce the powder into the holes. When the test sample is in the form of an ointment, it may be heated to a temperature of not more than

17、 50 C for not longer than 30 min before being introduced into the holes. In each case, ensure that no antiseptic encroaches on to the surface of the medium around the hole. 5.4 Incubate the Petri dish at (37 2) C for (18 to 24) h. 5.5 At the end of this period remove the Petri dish from the incubato

18、r and around the five holes containing the antiseptic. Measure to the nearest millimetre the diameters of the zones of inhibition of growth of the test organism. 5.6 Take the average of the five diameters and record this to the nearest millimetre. 5.7 Repeat the procedure described in 5.4 to 5.6 (in

19、clusive) using, successively, the E.coli, and P. aeruginosa test organism suspensions to prepare the test medium in 5.1. SABS This standard may only be used and printed by approved subscription and freemailing clients of the SABS. SABS Standards Division The objective of the SABS Standards Division

20、is to develop, promote and maintain South African National Standards. This objective is incorporated in the Standards Act, 2008 (Act No. 8 of 2008). Amendments and Revisions South African National Standards are updated by amendment or revision. Users of South African National Standards should ensure

21、 that they possess the latest amendments or editions. The SABS continuously strives to improve the quality of its products and services and would therefore be grateful if anyone finding an inaccuracy or ambiguity while using this standard would inform the secretary of the technical committee respons

22、ible, the identity of which can be found in the foreword. Tel: +27 (0) 12 428 6666 Fax: +27 (0) 12 428 6928 The SABS offers an individual notification service, which ensures that subscribers automatically receive notification regarding amendments and revisions to South African National Standards. Te

23、l: +27 (0) 12 428 6883 Fax: +27 (0) 12 428 6928 E-mail: salessabs.co.za Buying Standards Contact the Sales Office for South African and international standards, which are available in both electronic and hardcopy format. Tel: +27 (0) 12 428 6883 Fax: +27 (0) 12 428 6928 E-mail: salessabs.co.za South

24、 African National Standards are also available online from the SABS website http:/www.sabs.co.za Information on Standards The Standards Information Centre provides a wide range of standards-related information on both national and international standards, and is the official WTO/TBT enquiry point fo

25、r South Africa. The Centre also offers an individual updating service called INFOPLUS, which ensures that subscribers automatically receive notification regarding amendments to, and revisions of, international standards. Tel: +27 (0) 12 428 6666 Fax: +27 (0) 12 428 6928 E-mail: infosabs.co.za Copyri

26、ght The copyright in a South African National Standard or any other publication published by the SABS Standards Division vests in the SABS. Unless exemption has been granted, no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means without prior written p

27、ermission from the SABS Standards Division. This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any purpose other than implementation, prior written permission must be obtained. Details and advice can be obtained from the Senior Manager. Tel: +27 (0) 12 428 6666 Fax: +27 (0) 12 428 6928 E-mail: infosabs.co.za This standard may only be used and printed by approved subscription and freemailing clients of the SABS.