ISO 18562-2:2017 pdf – Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter.
This 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 PATIENT in all environments. The tests of this document are intended to quantify particles from 0,2 μm DIAMETER to 10 μm 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 does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 μm 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 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 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 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 series.
2 Normative references The 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 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 14971:2007, Medical devices – Application of risk management to medical devices ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process 3 Terms and definitions For 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 http://www.electropedia.org/ – – ISO Online browsing platform: available at http://www.iso.org/obp NOTE For convenience, an alphabetized index of all defined terms and their sources used in this document is given in Annex C. 3.1 DIAMETER AERODYNAMIC DIAM ETER diameter of a sphere of density 1 g/cm3 with 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, pressure and relative humidity [SOURCE: ISO 7708:1995, 2.2, modified – added“of interest, regardless of its geometric size, shape and true density”]
If the RISK MANAGEMENT PROCESS determines that testing is required, the 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 overview There is a 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 PATIENT 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 over 0,2 μum, and consider the limit to be 12 μg/m3 for 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 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 MATTER is below the allowed amount.