1、BSI Standards PublicationBS EN ISO 23747:2015Anaesthetic and respiratoryequipment Peak expiratoryflow meters for the assessmentof pulmonary function inspontaneously breathinghumansBS EN ISO 23747:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO23747:2015
2、. It supersedes BS EN ISO 23747:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/9, Lung Ventilators b) the name or trade name and address of the manufacturer, and where the manufacturer does not have an address within the locale, an authoriz
3、ed representative within the locale, to which the responsible organization can refer;c) where appropriate, an identification reference to the batch code, preceded by the word LOT, or serial number, or symbol 5.1.5 or 5.1.7 from ISO 15223-1:2012;d) indications with regard to proper disposal, as appro
4、priate.Check compliance by inspection.5.2.2 Marking of the pefm packagingThe following shall be marked on the packaging:a) details to enable the user to identify the pefm and the contents of the packaging;b) for a sterile pefm, the word “STERILE” or the appropriate symbol 5.2.1, 5.2.2, 5.2.3, 5.2.4
5、or 5.2.5 from ISO 15223-1:2012;c) for a pefm with an expiration date, symbol 5.1.4 from ISO 15223-1:2012;d) for a single use pefm, the words “single use only” or “do not re-use” or symbol 5.4.2 from ISO 15223-1:2012 (for a specific model or type reference, the indication of single use shall be consi
6、stent for the model or type reference);e) any special storage and/or handling instructions;f) any special operating instructions; g) the intended purpose of the pefm.Check compliance by inspection.4 ISO 2015 All rights reservedBS EN ISO 23747:2015ISO 23747:2015(E)5.3 Instructions for useThe accompan
7、ying documentations shall include the following:a) the intended purpose of the pefm including any restrictions on its use;b) the name or trade name and address of the manufacturer, and where the manufacturer does not have an address within the locale, an authorized representative within the locale,
8、to which the responsible organization can refer;c) a statement, if applicable, that the performance of the pefm can be affected by the patient spitting or coughing into the pefm or by extremes of temperature, humidity and altitude;d) if the pefm is intended to be dismantled by the user, the correct
9、method of reassembly;e) details of what the user should do if unusual readings are obtained;f) recommended storage conditions;g) details about cleaning and disinfection or cleaning and sterilization methods that can be used and a list of the applicable parameters such as temperature, pressure, humid
10、ity, time limits and number of cycles that the pefm parts can tolerate;h) the highest resistance to flow within the measurement range of the pefm and the flowrate at which this occurs;i) details of the nature and frequency of any maintenance and/or calibration needed to ensure that the pefm operates
11、 properly and safely;j) error of the measured value (see 7.1);k) information concerning the disposal of the pefm and its components (e.g. a battery);l) a unique version identifier such as the date of issue.Check compliance by inspection.5.4 Technical descriptionThe technical description shall includ
12、e the following:a) specification of the signal input/output part, if applicable;b) a statement to the effect that the values displayed by the instrument are expressed as btps values;c) any correction factors to be applied for changes in ambient conditions.Check compliance by inspection.6 pefm measur
13、ement rangeThe measurement range shall, as a minimum, be marked from 60 l/min (1,00 l/s) to 800 l/min (13,33 l/s) and shall be expressed at btps conditions. The marked measurement range may be wider than the minimum required range.Check compliance by inspection. ISO 2015 All rights reserved 5BS EN I
14、SO 23747:2015ISO 23747:2015(E)7 Performance requirements7.1 Error of measurementThe maximum permissible error for flowrate in the measurement range shall be 10 l/min (0,17 l/s) or 10 % of the reading, whichever is greater. This applies under the following environmental conditions: ambient temperatur
15、e from 10 C to 35 C; relative humidity from 30 % RH to 75 % RH; altitude from 0 m to 1 400 m (atmospheric pressure range from 1 060 hPa to 850 hPa).Check compliance by the tests of Annex B.7.2 LinearityThe difference between the mean error at any two consecutive test flowrates (see Annex B) shall no
16、t exceed 5 % of the larger of the two test flowrates.Under ambient conditions, the pefm reading at any peak flowrate in the measurement range shall not vary by more than 10 l/min (0,17 l/s) or 5 % of the mean of the readings, whichever is greater.Check compliance by the tests of Annex B.7.3 Resistan
17、ce to flowThe resistance to flow across the measurement range of the pefm shall not exceed 0,36 kPa/l/s (0,006 kPa/l/min).Check compliance by the tests of Annex B.7.4 Frequency responseThe difference between the indicated pef value of the pefm for profiles A and B (see B.2.1, C.2.1, C.2.2, and Figur
18、e C.1) shall, for an identical reference pef, not exceed 15 l/min (0,25 l/s), or 12 %, whichever is greater.Check compliance by the tests of Annex C.8 Dismantling and reassembly8.1 If intended for dismantling by the user, the pefm shall be designed or marked to indicate correct reassembly when all p
19、arts are mated.Check compliance by inspection.8.2 After dismantling and reassembly in accordance with the instructions for use, the pefm shall meet the requirements of Clause 7 and its readings shall not have changed by more than 10 % or 10 l/min (0,17 l/s), whichever is greater.Check compliance by
20、the tests of Annex D.9 Effects of mechanical ageingIf the pefm has moving parts as part of the flowrate sensing/indicating means, then after being tested in accordance with Annex D, the pefm shall meet the requirements of Clause 7 and its readings shall not have changed by more than 10 % or 10 l/min
21、 (0,17 l/s), whichever is greater.6 ISO 2015 All rights reservedBS EN ISO 23747:2015ISO 23747:2015(E)10 Effects of dropping a hand-held pefmA hand-held pefm shall meet the requirements of Clause 7 and its readings shall not have changed by more than 10 % or 10 l/min (0,17 l/s), whichever is greater,
22、 following the 1 m drop test of IEC 60601-1:2005 + A1:2012, 15.3.4.1.Check compliance by the tests of Annex D.11 Cleaning, sterilization, and disinfection11.1 Reusable pefm and partsAll components specified in the accompanying documentations for reuse and which come into contact with the patient or
23、breathing gases shall be capable of being cleaned and disinfected or cleaned and sterilized.Compliance is checked by a review of the accompanying documentations for methods of cleaning and disinfection or cleaning and sterilization see 5.3, f) and by inspection of the relevant validation reports.11.
24、2 pefm and parts delivered sterileA pefm or accessories labelled “sterile” shall have been sterilized using an appropriate, validated method as described in ISO 14937.Compliance is checked by inspection of the relevant validation reports.12 Compatibility with substancesA pefm and parts thereof shall
25、 be designed and manufactured to minimize health risks due to substances leached from the pefm or its components during operation, including routine inspection and adjustments by the user, in accordance with the instructions for use.Particular attention should be paid to the toxicity of materials an
26、d their compatibility with substances and gases with which they come into contact during use, including routine inspection and adjustments by the user, in accordance with the instructions for use.Compliance is checked by inspection of the relevant validation reports.13 BiocompatibilityA pefm and par
27、ts thereof intended to come into contact with biological tissues, cells, body fluids, or breathing gases shall be assessed and documented according to the guidance and principles given in ISO 10993-1.Compliance is checked by inspection of the relevant validation reports. ISO 2015 All rights reserved
28、 7BS EN ISO 23747:2015ISO 23747:2015(E)Annex A (informative) Rationale for tests and examples of test apparatusA.1 Test ProfilesSee also Annexes B and C. The reason for using test profiles is to ensure that a pefm can record the pef accurately for a defined group of patients who are likely to use th
29、ese instruments (the intended patient population). The 26 ATS profiles were chosen to be “representative” profiles that should be used to test a pefm. However, there is no evidence supplied with these profiles to show that they truly reflect the range of pefm characteristics found in the intended pa
30、tient population. The rt and dt characteristics for pefs in a large population of normal subjects and patients with airflow limitation have been published 21. For the whole population of 912 subjects (normal and those with airflow limitation) the centiles for rt and dt are shown in Table A.1.Table A
31、.1 Centiles for rt and dtValues in millisecondsCentile RT DT2,5 th24 115 th29 1450 th62 3595 th128 10697, 5 th155 138From these data it was evident that the 26 ATS profiles do not cover the full range of pef characteristics in the intended patient population and there can be some redundancy when tes
32、ting with all 26. This International Standard tests a pefm with profiles that span the 90 % confidence limits for the defining characteristics relating to pef measurement using just two profiles. Profile A (Figure C.1) has rt and dt at the upper 95thcentile and profile B has rt and dt at the lower 5
33、thcentile so they cover 90 % of the intended patient population characteristics.Where possible, this International Standard takes steps to reduce the number of individual tests required to ensure that the pefm has been adequately tested.The profiles have been derived from a single subjects recorded
34、flowrate time profile. The segment from the start of the blow (start of expiration) to pef is adjusted in the time domain to derive the desired rt, and the segment after pef is then similarly adjusted to give the desired dt. If the resulting profile lasts longer than 0,8 s, the flowrate is linearly
35、reduced to zero flowrate at 1,0 s. Since the shape of the profile at this point is not relevant to measuring pef, the profiles are capped at 1 000 data points at 1 ms intervals.Profile A has rt and dt at the upper 95thcentile for a population including normal subjects and patients with airflow limit
36、ation. Profile B has rt and dt at the 5thcentile for such a population. The range of rt and dt specified allows for possible error in producing output profiles with these shapes.8 ISO 2015 All rights reservedBS EN ISO 23747:2015ISO 23747:2015(E)A.2 PerformanceA.2.1 GeneralThe performance of a pefm i
37、nvolves three aspects: error, linearity and repeatability; frequency response; resistance.A.2.2 Error, linearity, and repeatabilityError, linearity, and repeatability can be tested using a simple profile that has an rt and dt at the upper 95thcentile. Pump systems can produce such a profile very acc
38、urately. Profile A is such a profile, i.e. smooth and without artefact.An apparatus suitable for this purpose (see Figure A.1) could be a mechanical syringe or piston pump. This type of apparatus can be manufactured with sufficient accuracy that can be verified by independent measurement. The motor
39、and drive to the piston should be sufficient to deliver a pef of 720 l/min (12,00 l/s) within 50 ms. The motor should incorporate an independent means for verifying its position, for example by the use of an optical shaft encoder or similar apparatus. The seal to the piston should allow a chamber pr
40、essure of 8 kPa with a leak of less than 3 l/min. Such equipment should not be used to deliver profiles with a short rt or a short dt since complex interactions within the chamber affect the true output flowrate.Key1 syringe or piston pump2 motor3 profile4 computerFigure A.1 Schematic diagram of tes
41、t apparatusA.2.3 Frequency responseThe frequency response is more difficult to test since many pefms do not have an analogue waveform output for recording. For a pefm to have adequate frequency response, it should be able to record a given pef to the same parameters whether it is from a profile with
42、 a short rt and a long dt (profile A) ISO 2015 All rights reserved 9BS EN ISO 23747:2015ISO 23747:2015(E)or from a profile with a short rt and a short dt (profile B). It is thus proposed that this aspect of pefm performance be tested using profiles A and B at the same delivered flowrate, and the rea
43、dings from the pefm be compared. They should agree within the accuracy limits in this International Standard.A.2.4 ResistanceFor reflecting the real use of a pefm, a dynamic test is more appropriate than a test using steady flow conditions. A concurrent test of linearity, accuracy, and repeatability
44、 using profile A and the test method described in Annex B is utilized. Under these conditions, all aspects of the profiles delivery can be ensured so that the resistance can be accurately determined across the measurement range of the pefm.A.3 ApparatusPump systems of differing design (see Reference
45、 17) and an explosive decompression apparatus (see Reference 22) have all been proposed for the testing of a pefm. Pump systems have the advantage that their output can be traced back to a standard. The relevant components such as the piston, the chamber drive mechanism, and the performance of the m
46、otor can all be verified. The timing of movement, which relates to the accuracy of oscillations and the pump position in relation to time, can be checked by optical shaft encoders. Pump systems have been used to test pefms with a wide range of profiles but until recently, their output did not accura
47、tely follow the input when profiles with a short dt and, to a lesser extent, a short rt, were delivered without the use of an independent flowmeter (see Reference 20).Recent developments by some pump manufacturers 1)have overcome these restrictions and are producing pump systems that are able to del
48、iver short rt and short dt profiles. Explosive decompression equipment is able to deliver short rt and short dt profiles. One limitation in this context is that their output cannot be traced back to a standard without the use of an independent flow meter. However, for testing frequency response, it
49、is not necessary for the output of this type of apparatus to be accurately calibrated; the only requirement is that the output is the same for the two types of profile. An explosive decompression apparatus fitted with a fast response solenoid whose position can be varied in real time can deliver the same output to a given pefm if the discharge pressure and solenoid opening aperture are kept the same. An independent flow meter with adequate frequency response of its analogue waveform output is needed only to verify that the shape of the p
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