1、BS ISO 18562-2:2017Biocompatibility evaluation of breathing gas pathways in healthcare applicationsPart 2: Tests for emissions of particulate matterBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18562-2:2017 BRITISH STANDARDNational forewordThis British Stand
2、ard is the UK implementation of ISO 18562-2:2017. The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/9, Lung Ventilators informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a sm
3、aller type; test specifications: italic type; terms defined in Clause 3 of this document or as noted: small capitals type.In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.The verbal forms used in this document con
4、form to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this document; “should” means that compliance with a requirement or a test is recom
5、mended but is not mandatory for compliance with this document; “may” is used to describe a permissible way to achieve compliance with a requirement or test.An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rational
6、e related to that item in Annex A. ISO 2017 All rights reserved vBS ISO 18562-2:2017ISO 18562-2:2017(E)The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised ISO publ
7、ication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of pub
8、lication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.vi ISO 2017 All rights reservedBS ISO 18562-2:2017INTERNATIONAL STANDARD ISO 18562-2:2017(E)Biocompatibility evaluation of breathing gas pathways in healthcare applicat
9、ions Part 2: Tests for emissions of particulate matter1 ScopeThis document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a p
10、atient in all environments. The tests of this document are intended to quantify particles from 0,2 m diameter to 10 m diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document
11、 does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 m in diameter.NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements
12、of some authorities having jurisdiction.This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.This document addresses potential contamination of the gas stream arising from the gas path
13、ways, which is then conducted to the patient.This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.This document does not address biological evaluation of the surfaces of gas pathways tha
14、t are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (includi
15、ng gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-p
16、ieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.This document does not address contamination alr
17、eady present in the gas supplied from the gas sources while medical devices are in normal use.EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected
18、 or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B. ISO 2017 All rights reserved 1BS ISO 1856
19、2-2:2017ISO 18562-2:2017(E)2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the refe
20、renced document (including any amendments) applies.ISO 7396-1:2016, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuumISO 14971:2007, Medical devices Application of risk management to medical devicesISO 18562-1:2017, Biocompatibility evaluation of breathing
21、 gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 7396-1, ISO 14971, ISO 18562-1 and the following apply.ISO and IEC maintain terminological database
22、s for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obpNOTE For convenience, an alphabetized index of all defined terms and their sources used in this document
23、is given in Annex C.3.1diameteraerodynamic diameterdiameter of a sphere of density 1 g/cm3with the same terminal velocity due to gravitational force in calm air as the particle of interest, regardless of its geometric size, shape and true density, under the prevailing conditions of temperature, pres
24、sure and relative humiditySOURCE: ISO 7708:1995, 2.2, modified added “of interest, regardless of its geometric size, shape and true density”4 General principles4.1 Type testsThe tests described in this document are type tests. Type tests are performed on the final medical device, a component of the
25、medical device or a representative sample of the medical device, part or accessory being evaluated. If representative samples are used (i.e. manufactured and processed by equivalent methods), consideration should be given to whether or not the differences between the representative sample and the fi
26、nal medical device or component could affect the results of the test. Testing of representative samples (manufactured and processed by equivalent methods) instead of the final medical device should be supported by a description of any differences between the representative sample and the final medic
27、al device, and a detailed rationale for why each difference is not expected to impact the biocompatibility of the final medical device.NOTE Some authorities having jurisdiction evaluate these differences and rationales.4.2 GeneralAll gas pathways from which the patient inspires gas shall be evaluate
28、d using the strategy detailed in ISO 18562-1.2 ISO 2017 All rights reservedBS ISO 18562-2:2017ISO 18562-2:2017(E)5 * Particulate matter emissions5.1 GeneralA medical device, part or accessory shall not add to the gas that could be inspired by the patient levels of particulate matter: less than or eq
29、ual to 2,5 m diameter, in excess of 12 g/m3; less than or equal to 10 m diameter, in excess of 150 g/m3.NOTE 1 The allowable limits are taken from the US EPA 40 CFR Part 505.All gas pathways from which the patient inspires gas shall be evaluated for particulate matter emissions. The evaluation shoul
30、d use the risk management process to assess if testing is required.NOTE 2 The evaluation of some components, which are identical in formulation, processing and preparation for use to an existing component of a medical device that has been previously tested, might conclude that no further testing is
31、required. Refer to ISO 18562-1:2017, Figure 2.Evaluation and, if required, testing shall take in to account: the expected service life; the effects of any intended processing or reprocessing; the worst-case patient exposure.The manufacturer shall document this evaluation as well as the criteria for
32、selection of test articles and methodologies, including component parts to be tested, duration of testing in relation to the intended duration of clinical use.NOTE 3 Some authorities having jurisdiction evaluate these rationales.If the risk management process determines that testing is required, the
33、 testing according to 5.5, 5.6, or 5.7 shall be performed. For testing according to 5.5, use the setup according to either 5.3 or 5.4. The manufacturer may choose the appropriate test method.Compliance is checked by risk management plan and risk management file.5.2 Testing methods overviewThere is a
34、 great variety of components and medical devices within the scope of this document, and so several different methods are proposed. The manufacturer should select the most appropriate method for their particular application. A simple component such as a connector with minimal area exposed to the pati
35、ent breathing gas stream is very unlikely to need testing for particulate matter, while a mechanical medical device with moving parts such as a ventilator could well require thorough testing.The simplest method (described in 5.3) is to use a single particle filter to trap everything with a diameter
36、over 0,2 m, and consider the limit to be 12 g/m3for all trapped particles. This is a quick simple test that does not differentiate particle sizes. It may be sufficient for simple medical devices. It is very difficult to measure very small amounts of particulate matter captured using a barrier filter
37、 test method since the mass of the filter is substantially more than that of the particulate matter. The volume of gas used in the test should therefore be large enough to capture a sufficiently large amount of particulate matter to be able to measure it or prove that the total mass of particulate m
38、atter is below the allowed amount.If the manufacturer wishes to test for the different particle sizes, with the different limits as detailed from the US EPA 40 CFR Part 505, then a full test using inertial particle separators and filters ISO 2017 All rights reserved 3BS ISO 18562-2:2017ISO 18562-2:2
39、017(E)following the general principles described in 40 CFR Part 50 is required. This is described in more detail in 5.6.A third alternative is to use a particle counter. The particle count measured by these instruments needs to be converted into an estimate of g/m3. A method is suggested in 5.7.5.3
40、Single filter test setupThis is a simple method suitable for suspected low levels of particulate matter.In principle, if sufficiently clean input gas is available, then a single measurement of particulate matter contamination in the output gas stream is sufficient. All of the particulate matter meas
41、ured is considered to have come from the medical device itself as indicated in Figure 1. For a simple, low flow medical device, this may be sufficient.NOTE It is important to ensure that the filter is validated for filtration of particles in airstreams, and that it is suitable for the airflow being
42、used.The input gas stream may be cleaned by passing all the input air through a 0,2 m filter before the medical device. Then the measuring filter on the output only measures particulate matter that originates from the medical device itself.Key1 clean input airstream, filtered if necessary2 one or mo
43、re medical devices under test3 0,2 m filterTo produce a meaningful result, more than one medical device may be required to be placed in series or measured sequentially.Figure 1 Example test setup for full flowIf the medical device operates with a flowrate, in excess of that which reasonably dimensio
44、ned filters can handle, then a different approach may be utilized. For these flowrates, it is not feasible to have the full flow pass through the 0,2 m filter, so a fractional sampling method is used as indicated in Figure 2. A subatmospheric pressure (partial vacuum) source may be used to draw the
45、sample volume through the measurement filter.4 ISO 2017 All rights reservedBS ISO 18562-2:2017ISO 18562-2:2017(E)Key1 clean input airstream2 one or more medical devices under test3 output airstream4 sampled airstream5 0,2 m filterTo produce a meaningful result, more than one medical device may be re
46、quired to be placed in series or measured sequentially.Figure 2 Example single filter test setup for a sampled flow5.4 Double filter test setupIf sufficiently clean input air is not available for a medical device, then a double sampling technique may be used. The principle is to measure the amount o
47、f particulate matter in the airstream entering the medical device (measurement 1) and simultaneously measure the amount of particulate matter in the airstream leaving the medical device (measurement 2), and then subtract the first from the second to get the amount of particulate matter added to the
48、airstream by the medical device itself. This method is indicated in Figure 3. A subatmospheric pressure (partial vacuum) source may be used to draw the sample volume through the measurement filters. ISO 2017 All rights reserved 5BS ISO 18562-2:2017ISO 18562-2:2017(E)Key1 input airstream2 Medical dev
49、ice under test3 output airstream4 sampled airstream 15 0,2 m filter, measurement 16 sampled airstream 27 0,2 m filter, measurement 2To produce a meaningful result, more than one medical device may be required to be placed in series or measured sequentially.Figure 3 Example double filter test setup for a sampled flow5.5 Test methodPerform filter method particulate matter emission testing as follows.a) Choose filters that are suitable for the flowrates passing through them.b) Weigh the 0,2 m rated filter.c) O
