SANS 584-2008 Soda-lime granules (with indicator) for use during anaesthesia for carbon dioxide absorption《在麻醉过程中所用的用于吸收二氧化碳的碱石灰颗粒剂(带指示剂)》.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 987-0-626-21429-6 SANS 584:2008Edition 1 SOUTH AFRICAN NATIONAL STANDARD Soda-lime granules (with indicator) for use during anaesthesia for carbon d

4、ioxide absorption Published by Standards South Africa 1 dr lategan road groenkloof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 584:2008 Edition 1 Table of changes Change No. Date Scope Foreword This South

5、African standard was approved by National Committee StanSA SC 5140.37C, Medical devices Anaesthetic and respiratory equipment, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This document was published in June 2008. Annex B forms an inte

6、gral part of this document. Annexes A, C and D are for information only. SANS 584:2008 Edition 1 1 Contents Page Foreword 1 Scope . 3 2 Normative references 3 3 Definitions . 3 4 General 4 5 Requirements . 4 5.1 Indicator. 4 5.2 Identification 4 5.3 Loss on drying. 5 5.4 Moisture absorption. 5 5.5 C

7、arbon dioxide absorption and colour change . 5 5.6 Hardness of granules 5 5.7 Size of granules 5 6 Methods of test 5 6.1 General 5 6.2 Identification tests . 5 6.3 Loss on drying. 6 6.4 Moisture absorption. 7 6.5 Carbon dioxide absorption 7 6.6 Hardness of granules 8 6.7 Size of granules 9 7 Packing

8、 and marking. 9 Annex A (informative) Colour change of indicators typically used with soda lime. 11 Annex B (normative) Precautionary measures to be implemented when using soda-lime granules . 11 Annex C (informative) Equivalent mesh designations for sieves with nominal aperture sizes expressed in i

9、nches, millimetres and microns 12 Annex D (informative) Quality verification of soda-lime granule (with indicator) for use during anaesthesia for carbon dioxide absorption 12 Bibliography. 13 SANS 584:2008 Edition 1 2 This page is intentionally left blank SANS 584:2008 Edition 1 3 Soda-lime granules

10、 (with indicator) for use during anaesthesia for carbon dioxide absorption 1 Scope This standard specifies the requirements for soda-lime granules with indicator for use in closed and semi-closed breathing circuits. Soda lime allows for rebreathing of volatile anaesthetics by absorbing carbon dioxid

11、e. 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 latest edition of the referenced document (including any amendments) applies. Information on currentl

12、y valid national and international standards can be obtained from Standards South Africa. SANS 3310-1/ISO 3310-1, Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth. 3 Definitions For the purposes of this document, the following definitions apply. 3.1 acceptable a

13、cceptable to the authority administering this standard, or to the parties concluding the purchase contract, as relevant 3.2 aperture size dimension defining an opening in a sieving medium ISO 2395:1990 3.3 batch that quantity of soda-lime granules with the same physical characteristics and compositi

14、on, that is manufactured and packed in the same cycle of operations 3.4 capnograph instrument used during anaesthesia to measure the carbon dioxide content in inspired and expired gases SANS 584:2008 Edition 1 4 3.5 mesh number of openings per linear inch in the woven wire cloth of a sieving medium

15、3.6 nest of test sieves set of two or more test sieves assembled in accordance with increasing aperture size from bottom to top, and with a lid and a receiver ISO 2395:1990 3.7 sieving medium surface containing regularly arranged apertures of uniform size and shape 3.8 woven wire cloth sieving mediu

16、m produced by a wire weaving process to form square apertures of uniform size 4 General 4.1 Soda lime consists predominantly of calcium hydroxide with varying amounts of sodium hydroxide, usually less than 4 % by mass. Small amounts of potassium hydroxide can also be present. 4.2 Soda lime used for

17、carbon dioxide absorption can contain additional components that are inert towards anaesthetic gases, such as kieselguhr, to increase hardness, promote binding and prevent dust formation, and to increase the porosity and absorptivity of the granules. 5 Requirements 5.1 Indicator The soda-lime granul

18、es shall contain an indicator that is inert towards anaesthetic gases and changes colour when the soda lime can no longer absorb carbon dioxide. NOTE 1 The colour change of indicators typically used with soda lime is given in annex A. NOTE 2 Precautionary measures to be implemented when using soda-l

19、ime granules in the anaesthetic environment are given in annex B. 5.2 Identification 5.2.1 Alkalinity When tested in accordance with 6.2.1, the litmus paper shall turn blue immediately. 5.2.2 Calcium When tested in accordance with 6.2.2, the granules shall give a positive reaction for calcium. 5.2.3

20、 Sodium When tested in accordance with 6.2.3, the granules shall give a positive reaction for sodium. SANS 584:2008 Edition 1 5 5.3 Loss on drying When tested in accordance with 6.3, the loss on drying represented by the loss in mass shall not be less than 12,0 g/100 g and not more than 19,0 g/100 g

21、. 5.4 Moisture absorption When tested in accordance with 6.4, the moisture absorption represented by the increase in mass shall not exceed 7,5 g/100 g. 5.5 Carbon dioxide absorption and colour change When tested in accordance with 6.5, the carbon dioxide absorbed, represented by the increase in mass

22、, shall be at least 19,0 g/100 g and the soda-lime granules used in the test shall change to the colour specified by the manufacturer and as indicated on the container (see 7.2(i). 5.6 Hardness of granules When tested in accordance with 6.6, the mass of the granules retained on the sieve with a nomi

23、nal aperture size of 2,00 mm shall be at least 37,5 g. 5.7 Size of granules When tested in accordance with 6.7, a) all the granules shall pass through the sieve of nominal aperture size 9,5 mm; b) not more than 7 g/100 g of the granules shall be retained on the large aperture sieve; c) not more than

24、 15 g/100 g of the granules shall pass through the small aperture sieve; and d) not more than 2 g/100 g of the granules shall pass through the sieve of nominal aperture size 425 m. 6 Methods of test 6.1 General Unless otherwise specified, only use reagents of analytical reagent grade or of the pures

25、t grade available. 6.2 Identification tests 6.2.1 Alkalinity 6.2.1.1 Place a granule on a piece of red litmus paper moistened with purified water and observe whether the paper turns blue immediately. 6.2.1.2 Check for compliance with 5.2.1. SANS 584:2008 Edition 1 6 6.2.2 Calcium 6.2.2.1 Reagents 6.

26、2.2.1.1 Acetic acid, c(CH3COOH) = 6 mol/L Dilute 34 mL of glacial acetic acid to 100 mL with purified water. 6.2.2.1.2 Ammonium hydroxide solution, c(NH4OH) = 6 mol/L Dilute 40 mL of ammonium hydroxide (about 13,5 M) to 100 mL with purified water. 6.2.2.1.3 Ammonium oxalate solution, 3,5 g/100 mL Di

27、ssolve 3,5 g of ammonium oxalate (NH4)2C2O4) in 100 mL of purified water. 6.2.2.1.4 Hydrochloric acid solution, c(HCl) = 3 mol/L Dilute 26 mL of concentrated hydrochloric acid to 100 mL with purified water. 6.2.2.1.5 Methyl red indicator solution Dissolve 100 mg of methyl red in 100 mL of ethanol, a

28、nd filter if necessary. 6.2.2.2 Procedure 6.2.2.2.1 Dissolve a few granules in the acetic acid solution. 6.2.2.2.2 Add two drops of methyl red indicator solution and neutralize the solution with the ammonium hydroxide solution, i.e. until the first distinct colour change is visible. 6.2.2.2.3 Add th

29、e hydrochloric acid solution dropwise until the solution is acid to the indicator, i.e. until the solution turns red. 6.2.2.2.4 Add the ammonium oxalate solution dropwise and mix. A white precipitate that is insoluble in the acetic acid solution, but dissolves in the hydrochloric acid, indicates the

30、 presence of calcium. 6.2.2.2.5 Check for compliance with 5.2.2 6.2.3 Sodium 6.2.3.1 Moisten a granule with hydrochloric acid and introduce it on a platinum wire into the flame of a bunsen burner. A yellow colour imparted to the flame indicates the presence of sodium. 6.2.3.2 Check for compliance wi

31、th 5.2.3. 6.3 Loss on drying 6.3.1 Accurately determine the mass of about 10 g of the granules in a tared weighing dish. 6.3.2 Dry at (105 2) C for 2 h. 6.3.3 Redetermine the mass and express the decrease in mass as a percentage of the original mass. SANS 584:2008 Edition 1 7 6.3.4 Check for complia

32、nce with 5.3. 6.4 Moisture absorption 6.4.1 Reagent Sulfuric acid solution, 14 g/100 mL Cautiously add 8 mL of concentrated sulfuric acid to 50 mL of cooled purified water. Cool and dilute to 100 mL with purified water. 6.4.2 Procedure 6.4.2.1 Accurately determine the mass of about 10 g of the granu

33、les in a tared weighing dish of approximate diameter 50 mm and height 30 mm. 6.4.2.2 Place the dish, with the cover removed, over the sulfuric acid solution in a desiccator for 24 h. 6.4.2.3 Redetermine the mass and express the increase in mass as a percentage of the original mass. 6.4.2.4 Check for

34、 compliance with 5.4. 6.5 Carbon dioxide absorption 6.5.1 Apparatus 6.5.1.1 U-shaped drying tubes with side arms, of height approximately 150 mm and internal diameter approximately 15 mm. 6.5.1.2 Carbon dioxide, suitable source of medical grade carbon dioxide. NOTE Commercially available cylinders o

35、f medical grade carbon dioxide are recommended. 6.5.2 Procedure 6.5.2.1 Fill the lower transverse section of the U-tube with loosely packed glass wool. 6.5.2.2 Place about 5 g of anhydrous calcium chloride in one arm of the U-tube and accurately determine the mass of the U-tube with contents (m1). 6

36、.5.2.3 Place 9,5 g to 10,5 g of the granules in the other arm of the U-tube and redetermine the mass of the U-tube with contents (m2). 6.5.2.4 Insert stoppers in the open arms of the U-tube. Connect the side tube of the arm of the U-tube containing the granules to a drying tube containing anhydrous

37、calcium chloride. 6.5.2.5 Connect the drying tube to the supply of carbon dioxide. 6.5.2.6 Pass carbon dioxide through the U-tube at a rate of 75 mL/min for exactly 20 min. 6.5.2.7 Disconnect the U-tube. Allow to cool to ambient temperature. Remove the stoppers and redetermine the mass (m3). SANS 58

38、4:2008 Edition 1 8 6.5.2.8 Calculate the percentage increase in mass (M) using the following formula: M = 1223mmmm 100 where m3 is the numerical value of the mass of the U-tube, anhydrous calcium chloride and the granules after absorption by carbon dioxide, in grams; m2 is the numerical value of the

39、 mass of the U-tube, anhydrous calcium chloride and the granules, in grams ; m1 is the numerical value of the mass of the U-tube and anhydrous calcium chloride, in grams. Express the result to one decimal place. 6.5.2.9 Check for compliance with 5.5. 6.6 Hardness of granules NOTE The equivalent mesh

40、 designation of sieves with nominal aperture sizes expressed in inches, millimetres and microns is given in annex C. 6.6.1 Apparatus 6.6.1.1 Mechanical sieve shaker, with a frequency of oscillation of (285 3) cycles per minute. 6.6.1.2 Hardness pan, of diameter 200 mm and a concave brass bottom 7,9

41、mm thick at the circumference and 3,2 mm thick at the centre with an internal spherical radius of curvature of 109 cm. 6.6.1.3 Sieve, with a nominal aperture size of 2,00 mm that complies with SANS 3310-1. 6.6.2 Procedure 6.6.2.1 Screen 200 g of the granules on the sieve for 3 min using the mechanic

42、al sieve shaker. 6.6.2.2 Weigh 50,0 g of the granules retained on the sieve and place them in the hardness pan. 6.6.2.3 Add 15 steel balls, 7,9 mm in diameter, to the hardness pan and shake in the mechanical sieve shaker for 30 min. 6.6.2.4 Remove the steel balls and transfer the contents of the har

43、dness pan to the sieve and shake using the mechanical sieve shaker for 3 min. 6.6.2.5 Determine the mass of the granules retained on the sieve. 6.6.2.6 Check for compliance with 5.6. SANS 584:2008 Edition 1 9 6.7 Size of granules 6.7.1 Apparatus Sieves, that comply with the requirements of SANS 3310

44、-1, of nominal aperture size 9,5 mm, 425 m and of the small and large aperture sizes corresponding to the granular size range stated on the label (see 7.2(h). 6.7.2 Procedure 6.7.2.1 Assemble the nest of sieves in descending order of coarseness. 6.7.2.2 Screen 100 g of the granules for 5 min using t

45、he mechanical sieve shaker (see 6.6.1.1). 6.7.2.3 Determine the mass of the granules retained on each of the sieves and the mass of granules that pass through the sieve with a nominal aperture size of 425 m. 6.7.2.4 Check for compliance with 5.7. 7 Packing and marking 7.1 Packing 7.1.1 The soda-lime

46、 granules shall be packed in air-tight, vapour-proof containers of material that does not affect or will not be affected by the contents. 7.1.2 Soda lime packed in resealable multidose 4 kg or 5 kg canisters shall be provided with a wide dispensing port for free granule outflow. 7.1.3 The soda-lime

47、granules shall be packed so as to avoid granule disintegration and dust formation during handling and transportation. 7.1.4 The containers shall be of sufficient strength to withstand normal handling, transportation and storage. 7.1.5 The nominal mass of soda lime in a container shall be 500 g, 4 kg

48、, 5 kg or any other acceptable nominal mass as requested by the purchaser. 7.2 Marking The following information shall appear in legible and indelible marking on each container in at least English: a) the chemical composition of the soda lime, expressed as a percentage mass fraction; b) the trade na

49、me or trademark of the manufacturer; c) the address of the manufacturer; d) the batch designation prefixed by the word “LOT“; e) the words “Soda lime with indicator“; SANS 584:2008 Edition 1 10 f) the words “For carbon dioxide absorption“ (or equivalent); g) the words “High moisture“; h) the granular size range in terms of nominal aperture sieve sizes; NOTE Standard mesh designations may also be given. i) the colour change with absorption of carbon dioxide; j) the nominal mass of the contents; k) an instruction to “discard immediately after use when the colour c