ISO 18562-2 pdf download – Biocompatibility evaluation of breathing gas pathways in healthcare applications 一 Part 2: Tests for emissions of particulate matter.
NOTE 2 The evaluation olsorne 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 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 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.
lithe RISK MANAGEMENT PROCESS determines that testing is required, the testing according to 5.5. 5.6, or 5.Z shall be performed. For testing according to £5. use the setup according to either 5.3 or SA. The MANUFACTURER may choose the appropriate test method,
compliance is checked by RISI MANAGMNT plan and RISK MA NAGEMMT 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 £3) is to use a single particle filter to trap everything with a DIAMETER over 0.2 pm, and consider the limit to be 12 pg/rn3 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 tube able to measure it or prove that the total mass of PARTICULATE MATTER is below the allowed amount.
lithe MANUFACTURER wishes to test for the different particle sizes, with the different limits as detailed from the US EPA 40 CFR Part 50Il, then a full test using inertial particle separators and filters following the general principles described in 40 § CFR Pan 50 is required. This is described in more detail in 5.
A third alternative is to use a particle counter. The particle count measured by these instruments needs to be converted Into an estimate of pg/rn3. A method Is suggested In £2
5.3 Single filter test setup
This 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 measured is considered to have come from the MEDICAL DEVICE itself as indicated in Figure 1. For a simple, low flow MEDICAL DEVICE, this maybe 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 uset
The Input gas stream may be cleaned by passing all the Input air through a 0,2 pm fIlter before the MEDICAL DEVICE. Then the measuring filter on the output only measures PARTICULATE MATTER that originates from the MEDICAL DEVICE itself.
ISO 18562-2 pdf download – Biocompatibility evaluation of breathing gas pathways in healthcare applications 一 Part 2: Tests for emissions of particulate matter
