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 978-0-626-21783-9 SANS 451:2008Edition 1SOUTH AFRICAN NATIONAL STANDARD Spirometry Generation of acceptable and repeatable spirograms Published by S
4、ABS 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 451:2008 Edition 1 Table of changes Change No. Date Scope Acknowledgement The SABS Standards Division wishes to acknowledge the valuable assistance der
5、ived from publications of the National Institute for Occupational Safety and Health, the American Thoracic Society and the European Respiratory Society. Foreword This South African standard was approved by National Committee SABS SC 1039G, Medical devices Spirometry, in accordance with procedures of
6、 the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in November 2008. A reference is made in 6.1 and 10.1.3 to occupational and medical spirometry surveillance being conducted in compliance with and records being kept for the period specifie
7、d in “the current relevant national legislation“, respectively. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993) and the Mine Health and Safety Act, 1996 (Act No. 29 of 1996). Annex A forms an integral part of this document. Annexes B to F are for informat
8、ion only. SANS 451:2008 Edition 1 1 Contents Page Acknowledgement Foreword 1 Scope . 3 2 Normative references 3 3 Definitions and abbreviations 3 4 Types of spirometers. 7 4.1 Volume displacement spirometers 7 4.2 Flow-sensing spirometers . 8 5 Requirements 9 5.1 Equipment . 9 5.2 Spirometers. 10 5.
9、3 Calibration and accuracy checks 12 5.4 Test areas where spirometry is performed . 16 5.5 Hygiene and infection control 16 6 The subjects 17 6.1 Indications for spirometry 17 6.2 Contraindications for spirometry . 18 6.3 Procedure before each manoeuvre 18 7 Performance of the manoeuvres 20 7.1 Slow
10、 vital capacity (VC) manoeuvres . 20 7.2 Forced vital capacity (FVC) manoeuvres 22 7.3 Evaluation of each manoeuvre 23 8 Evaluation of the spirograms 24 8.1 Acceptability criteria 24 8.2 Repeatability criteria 27 8.3 Usability criteria. 27 9 Numerical results 28 9.1 FVC and VC 28 9.2 FEV128 9.3 FEV1
11、/FVC and FEV1/VC percentage ratios 29 9.4 Selection of the best test. 29 10 Records . 29 10.1 Test records 29 10.2 Equipment records 29 SANS 451:2008 Edition 1 2 Contents (concluded) Page Annex A (normative) Information to be supplied by the manufacturer. 30 Annex B (informative) Conversion of gas v
12、olumes from ATPS to BTPS. 31 Annex C (informative) Prediction equations used in spirometry 32 Annex D (informative) Example of a pre-pulmonary function report of a flow-sensing spirometer. 34 Annex E (informative) Test for bronchodilator response . 36 Annex F (informative) Flow diagram to illustrate
13、 the sequence of an FVC manoeuvre 37 Bibliography. 38 SANS 451:2008 Edition 1 3 Spirometry Generation of acceptable and repeatable spirograms 1 Scope 1.1 This standard covers the procedure to be followed for the generation of acceptable and repeatable spirograms for the purpose of occupational and m
14、edical surveillance of respiratory function in humans. 1.2 It covers the performance requirements and the calibration of the equipment used, hygiene and infection control where spirometry is performed, and the acceptability, repeatability and usability criteria applied to spirograms. 1.3 It does not
15、 cover the reproducibility criteria applied to manoeuvres, and the interpretation or grading of spirometry results nor the diagnosis or treatment of respiratory conditions or related diseases. 2 Normative references The following referenced documents are indispensable for the application of this doc
16、ument. For dated references, only the edition cited applies. For undated references, the 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 10248-1, M
17、anagement of healthcare waste Part 1: Management of healthcare risk waste from a healthcare facility. 3 Definitions and abbreviations 3.1 Definitions For the purposes of this document, the following definitions and abbreviations apply. 3.1.1 acceptable blow manoeuvre that complies with predetermined
18、 criteria SANS 451:2008 Edition 1 4 3.1.2 accessory additional part for use with the spirometer in order to achieve the intended use, adapt it to some special use, facilitate its use, and enable its functions to be integrated with those of other equipment NOTE A breathing system filter is considered
19、 an accessory. ISO/DIS 26782:2008 3.1.3 accuracy closeness of agreement between the result of a measurement and the conventional true value Miller, MR et al. (2005a:154) 3.1.4 adult person older than eighteen years 3.1.5 calibration procedure for establishing the relationship between sensor-determin
20、ed values of flow or volume and the actual flow or volume NOTE Adapted from Miller, MR et al. (2005a:154). 3.1.6 calibration check procedure used to validate that the device is within calibration limits (for example, the volume of a 3 L syringe shall be 3,5 % of the conventional true value of 3,0 L)
21、 NOTE Adapted from Miller, MR et al. (2005a:154). 3.1.7 dyspnoea difficult or laboured breathing 3.1.8 expiratory reserve volume maximal volume of air that can be expelled after normal tidal expiration and that is not measured by spirometry, expressed in litres at BTPS 3.1.9 forced expiratory flow F
22、EFX %average flow in litres per second when X % of the FVC has been expired NOTE The values for X commonly used are 25, 50 and 75. FEF(25 to 75) %average flow in litres per second between 25 % and 75 % of the FVC SANS 451:2008 Edition 1 5 3.1.10 forced expiratory volume in 1 s maximal volume of air
23、exhaled in the first second of the FVC manoeuvre, expressed in litres at BTPS 3.1.11 forced vital capacity maximal volume of air exhaled after maximal inspiration by means of a rapid, maximally forced expiratory effort, expressed in litres at BTPS 3.1.12 forced vital capacity manoeuvre spirometry te
24、st used to determine the FVC 3.1.13 functional residual capacity volume of air left in the lungs after a tidal expiration and that is not measured by spirometry, expressed in litres at BTPS 3.1.14 inspiratory capacity volume of air that can be inhaled after a tidal expiration, expressed in litres at
25、 BTPS 3.1.15 peak expiratory flow maximum flow generated with an FVC manoeuvre, expressed in litres per second (or litres per minute) at BTPS 3.1.16 precision closeness of agreement between results of successive measurements in relation to the mean value of the measurements 3.1.17 real-time spirogra
26、m graphic display generated as a manoeuvre is executed 3.1.18 repeatability closeness of agreement between results of successive measurements of the same item carried out under the same conditions and repeated over a short period of time NOTE Adapted from Miller, MR et al. (2005b:154). 3.1.19 reprod
27、ucibility closeness of agreement between results of successive measurements of the same item where at least one of the conditions of measurement is changed (for example, the method of measurement, the date, time, spirometer, spirometer operator, or the location) NOTE Adapted from Miller, MR et al. (
28、2005b:154). 3.1.20 residual volume volume of air left in the lungs after maximal expiration and that is not measured by spirometry, expressed in litres at BTPS SANS 451:2008 Edition 1 6 3.1.21 spirogram graphic display produced by a spirometer that includes waveform tracings of expiration and inspir
29、ation, volume-time curves and flow-volume loops 3.1.22 spirometer instrument used to measure inspiratory and expiratory volumes and flows 3.1.23 spirometer operator person performing spirometry 3.1.24 spirometry physiological test that measures how an individual inhales or exhales volumes of air as
30、a function of time 3.1.25 subject person undergoing a spirometry test 3.1.26 tidal breathing normal respiration at rest 3.1.27 time zero point selected in the measurement of the FEV1 as the start of the test and is obtained by using back extrapolation 3.1.28 total lung capacity volume of air contain
31、ed in the lung at the end of maximal inspiration and that is not measured by spirometry, expressed in litres at BTPS 3.1.29 vital capacity maximum volume of air that can be inhaled after maximum expiration (IVC) or the maximum volume of air exhaled after maximal inspiration (EVC), expressed in litre
32、s at BTPS 3.2 Abbreviations ATPS ambient temperature, ambient pressure, saturated with water vapour BTPS body temperature (37 C), ambient pressure, saturated with water vapour ERV expiratory reserve volume EV extrapolated volume EVC expiratory vital capacity FEF forced expiratory flow SANS 451:2008
33、Edition 1 7 FEV1 forced expiratory volume in 1 s FRC functional residual capacity FVC forced vital capacity IC inspiratory capacity IVC inspiratory vital capacity PEF peak expiratory flow RV residual volume TLC total lung capacity VC vital capacity 4 Types of spirometers 4.1 Volume displacement spir
34、ometers 4.1.1 Volume displacement spirometers record the volume of air exhaled directly within a certain time and produce volume-time curves. In conjunction with an appropriate potentiometer and associated computer software, flow-volume loops can be generated. An example of a volume-time curve and o
35、f an expiration flow-volume loop are given in figure 1(a) and figure 1(b), respectively. 4.1.2 Examples of volume displacement spirometers are the water-sealed type, the dry-rolling seal type, and the bellows type instruments. Figure 1(a) Volume-time curve SANS 451:2008 Edition 1 8 Figure 1(b) Flow-
36、volume loop of expiration NOTE The tracings are illustrative only and are not intended to represent graphical output that complies with the scale factor requirements given in 5.2.3. Figure 1 Spirograms generated by volume displacement spirometers 4.2 Flow-sensing spirometers 4.2.1 Flow-sensing spiro
37、meters use a flow sensor or a pneumotachometer to measure flow directly and to derive volumes. Flow-sensing spirometers also produce flow-volume loops and volume-time curves. An example of a flow-volume loop is given in figure 2. Figure 2 Flow-volume loop 4.2.2 Examples of flow sensor spirometers or
38、 pneumotachometer spirometers are the pressure differential types, the Fleisch type, the Lilly type, the hot wire anemometers, the Pitot tube types, and the ultrasonic and turbine pneumotachs. SANS 451:2008 Edition 1 9 5 Requirements 5.1 Equipment 5.1.1 General 5.1.1.1 The spirometer operator shall
39、ensure that the accuracy of the following equipment can be verified: a) the medical height rod (stadiometer); b) the medical weight scale; c) the barometer; d) the hygrometer; e) the thermometer; and f) the calibrated 3 L syringe. 5.1.1.2 The accuracy of the equipment can be verified through referen
40、ce to documentation provided by the supplier certifying the accuracy thereof, or through calibration of the equipment by an accredited test facility at intervals recommended by the manufacturer of the equipment. Damaged equipment that has been sent for repairs, or when there is reason to suspect the
41、 accuracy of the data produced, shall be recalibrated. 5.1.1.3 Unless a manufacturer states that the equipment will operate accurately at extended ambient conditions, the limits for the accuracy of measurements apply under the following environmental conditions: a) ambient temperature of (17 to 35)
42、C; b) relative humidity of (30 to 75) % RH; and c) ambient pressure of (600 to 1100) hPa or (450 to 825) mm Hg or (60 to 110) kPa. NOTE Millimetres mercury (mm Hg) can be converted to hectoPascals (hPa) by multiplying with 1,33322 and to kiloPascals (kPa) by dividing by 7,5. 5.1.2 Calibrated 3 L syr
43、inge 5.1.2.1 A calibrated 3 L syringe, identifiable by its serial number, shall be used to carry out the calibration check of the volume of the spirometer. The syringe shall have an accuracy of 0,5 % or 15 mL of full scale, whichever is greater. 5.1.2.2 The syringe shall be leak tested periodically
44、(for example, monthly, or more frequently when large numbers of manoeuvres are performed, or when there is reason to suspect the accuracy of the data produced), at more than one volume up to its maximum. The leak test shall be performed by applying pressure to the extended plunger with the outlet oc
45、cluded, and with the components that are going to be used with the syringe attached. Any movement of the plunger indicates a leak. 5.1.2.3 A syringe that has been accidentally dropped, has loose components, or has a leak shall be returned to the manufacturer for repair and recalibration or shall be
46、replaced. SANS 451:2008 Edition 1 10 5.1.3 Accessories used in-line with the spirometer 5.1.3.1 The airflow resistance of the spirometer, including its accessories and detachable parts, with flows up to 14 L/s, shall not exceed 0,15 kPa (L/s) (See A.1). 5.1.3.2 The manufacturer or supplier of the ac
47、cessories and detachable parts, as relevant, shall supply the information specified in A.2. 5.2 Spirometers 5.2.1 General 5.2.1.1 The spirometer shall include a facility a) able to convert the volume of gas exhaled, measured at ATPS to BTPS, to reflect conditions inside the lung. Without this facili
48、ty, mathematical correction of volumes can be done manually using the formula given in annex B, b) whereby the appropriate predicted reference values for children, Caucasians or non-Caucasian, can be selected and entered (see annex C), c) able to generate real-time spirograms in order to recognize t
49、est performance errors, d) with a monitor large enough to display numerical values and all spirograms clearly, e) able to provide a summary of the quality of the manoeuvres performed, f) able to alert the spirometer operator when pre-selected performance criteria have not been met, g) able to select the best test either automatically or manually, h) able to enter the ambient temperature, barometric pressure and humidity readings. Without this facility, data shall be recorded manually (see 5.2.1.1(a), i) able to save adequate data points
