1、BS ISO 18562-3:2017Biocompatibility evaluation of breathing gas pathways in healthcare applicationsPart 3: Tests for emissions of volatile organic compounds (VOCs)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18562-3:2017 BRITISH STANDARDNational forewordThi
2、s British Standard is the UK implementation of ISO 18562-3:2017. 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
3、is also in a smaller 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 th
4、is document conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:a) “shall” means that compliance with a requirement or a test is mandatory for compliance with this document;b) “should” means that compliance with a requirement
5、 or a test is recommended but is not mandatory for compliance with this document;c) “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
6、 guidance or rationale related to that item in Annex A. ISO 2017 All rights reserved vBS ISO 18562-3:2017ISO 18562-3:2017(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, amende
7、d or revised ISO publication 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
8、 from the date of publication 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 18562-3:2017INTERNATIONAL STANDARD ISO 18562-3:2017(E)Biocompatibility evaluation of breathing gas pathways i
9、n healthcare applications Part 3: Tests for emissions of volatile organic compounds (VOCs)1 ScopeThis document specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or
10、 supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of vocs that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.This doc
11、ument addresses potential contamination of the gas stream arising from the gas pathways, 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
12、document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series1.Medical devices, parts or accessories containing gas pathways that are addressed by this docume
13、nt include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, m
14、asks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces 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
15、 also addressed by this document.This document does not address contamination already 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
16、-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series.This document is intended to be read in conjunction with ISO 18562-1.NOTE This document has been prep
17、ared to address the relevant essential principles of safety and performance as indicated in Annex B.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 edit
18、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 7396-1:2016, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 2017 All rights reserved 1BS ISO 18562-3:2017ISO 18562-3:2017
19、(E)ISO 14971:2007, Medical devices Application of risk management to medical devicesISO 16000-6:2011, Indoor air Part 6: Determination of volatile organic compounds in indoor and test chamber air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using MS or MS-FIDISO
20、18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management processASTM D5466-01, Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology)3 Terms and
21、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 databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia
22、 .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 are given in Annex C.3.1ratedterm referring to a value assigned by the manufacturer for a specified operating condit
23、ionSOURCE: IEC 60601-1:2005, 3.973.2thermal stabilitycondition under which the temperature of an object does not change by more than 2 C over a period of 1 hSOURCE: IEC 60601-1:2005, 3.125, modified “increase” has been changed to “change”.4 General principles4.1 Type testsThe tests described in this
24、 document are type tests. Type tests are performed on the final medical device, a component of the 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), consider
25、ation should be made regarding whether or not the differences between the representative sample and the final 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 sho
26、uld be supported by a description of any differences between the representative sample and the final medical 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 di
27、fferences and rationales.4.2 GeneralAll gas pathways from which the patient inspires gas shall be evaluated using the strategy detailed in ISO 18562-1.2 ISO 2017 All rights reservedBS ISO 18562-3:2017ISO 18562-3:2017(E)The fundamental consideration in assessing a substance is “what is the dose to th
28、e patient of this substance?”Limits for toxicological purposes are most often quoted in g/d (tolerable exposure). Limits for environmental purposes, and the quantity that is measured by test laboratories, are usually quoted as concentrations in g/m3. To calculate the permitted concentration of that
29、substance (in g/m3) in the breathing gas, the total volume of gas inhaled in a day is required. The dose to the patient depends on the concentration of the substance (in g/m3) multiplied by the volume (in m3) inhaled by the patient.Standard daily breathing volumes are found in ISO 18562-1:2017, 6.3.
30、5 * Voc emissions5.1 GeneralAll gas pathways from which the patient inspires gas shall be evaluated for voc emissions. The evaluation should use the risk management process to assess if testing is required.NOTE 1 The evaluation of some components, which are identical in formulation, processing and p
31、reparation for use to an existing component of a medical device that has been previously tested, might conclude that no further testing is required. Refer to ISO 18562-1:2017, Figure 2.A medical device, part or accessory shall not add to the gas that could be inspired by the patient vocs at levels t
32、hat create an unacceptable risk to the patient.NOTE 2 Parts downstream of the patient can be evaluated for voc emissions if there is a risk that the patient might inspire gas that has been in contact with them.If the risk management process determines that testing is required, the tests of 5.3 shall
33、 be performed.5.2 Acceptance criteriaThe dose-to-patient of any substance for which a TI is calculated shall be below that TI.The dose-to-patient of any substance for which a TI is not calculated shall be below the TTC for all values relevant to the exposure category as indicated in Table 1.When the
34、 “first 24-h test” returns a very low value, below that allowed for longer term use, then further tests need not be performed.EXAMPLE 1 Where the limited exposure dose-to-patient of a substance is below 120 g/d for a prolonged exposure medical device, further testing is not required as shown in Figu
35、re 1, green bar E.EXAMPLE 2 Where the limited exposure or prolonged exposure dose-to-patient of a substance is below 40 g/d for a permanent contact medical device, further testing is not required as shown in Figure 1, green bar D.Table 1 TTC limits by exposureExposure categoryLength of patient expos
36、ureTtc ug/dLimited exposure24 h 360 Prolonged exposure24 h and 24 h, 24 h, 30 d), use medical devices. For the first sample period, start at the beginning of gas flowing through the medical device. For the second sample period, sample after the first 24 h of gas flowing through the medical device. F
37、or the third sample period, start at the end of the duration of use of the medical device where the duration of use is the maximum permitted duration of use on a patient, as determined by the manufacturer or upon reaching a value below the ti limit for each substance or the ttc, as applicable.3) For
38、 a permanent exposure (30 d) ,use medical device. For the first sample period, start at the beginning of gas flowing through the medical device. For the second sample period, sample after the first 24 h of gas flowing through the medical device. For the third sample period, start at the end 29 d or
39、upon reaching a value below the ti limit for each substance or the ttc, as applicable.The sample flowrate shall be low enough so as to not disturb the normal operation of the medical device.6 ISO 2017 All rights reservedBS ISO 18562-3:2017ISO 18562-3:2017(E)Keyc concentrationt time1 start of test2 s
40、ample at start3 sample at 24 h4 sample at end of use or at steady stateFigure 2 Typical decay curve Concentration as a function of timeThe sampling duration may be extended to result in a large enough sample volume to allow quantification down to the required detection limit or reduced to prevent ov
41、erloading of the sampling system. Additional sampling points may then be needed.For small medical devices or others that only emit very low amounts of voc, it is possible to do a test only at the start. The values at the start are most likely to be higher than the value at the end, so extrapolating
42、this start value across the whole duration of use seriously overestimates the dose the patient receives. If this calculated dose is acceptable, then testing need not be performed throughout the expected duration of use and may be performed only at the start.Components made of materials that are know
43、n not to emit vocs, such as ceramics or metals, need not be tested for vocs.f) Perform analysis of the samples using the methods of ISO 16000-6 or ASTM D5466-01 or a demonstrably equivalent method.NOTE 2 If there is an indication that there are vvocs in the analysis according to ISO 16000-6, then fu
44、rther testing using ISO 16000-6:2011, Annex D might be necessary.g) If added vocs are detected, identify the compounds and determine the level of each compound present in the samples. Compounds at concentrations below 2 g/m3need not be identified.NOTE 3 ISO 16000-6 contains information regarding sat
45、isfactory levels of identification. Compounds are quantified using the response factor of toluene when individual references are not available or the compound is unidentified. ISO 2017 All rights reserved 7BS ISO 18562-3:2017ISO 18562-3:2017(E)NOTE 4 Required detection levels for a specific compound
46、 can vary, depending on the allowed tolerable exposure. If the tolerable exposure is high or the time of exposure is short, then there is no need to use the precise analysis methods necessary for more toxic substances or longer exposures.h) Calculate the dose that the patient could receive.1) For pr
47、olonged exposure or permanent contact, use medical devices by calculating the concentrations of each compound over time (as the concentrations decline with time, as shown in the graph in Figure 2) and combining that with the volumes of gas reaching the lungs of the patient, as specified in d). Calcu
48、late the dose the patient receives in the first 24-h period and the dose the patient receives in following 24-h periods.2) For limited exposure, use medical devices by calculating the dose the patient receives of each compound within a 24-h period.i) Using the method outlined in ISO 18562-1:2017, Cl
49、ause 7, confirm that the dose the patient receives of any individual voc does not exceed the daily tolerable exposure for that compound.NOTE 5 ISO 18562-1:2017, Clause 7, contains more guidance on calculating tolerable exposure levels and allowable limits for identified and unidentified compounds.NOTE 6 The tolerable exposure for the first 24-h period is higher than for the subsequent 24-h periods.j) If the dose to the patient of one or more compounds exceeds the tolerable exposure, then the materials and manufacture of
