ISO 80601-2-69 Figure 21.101 Standard Resistance For Test Equipment

Product Description

ISO 80601-2-69 figure 21.101 standard resistance

201.9.6.2.1.101 Additional requirements for audible acoustic energy
a) The A-weighted sound pressure level emitted by the oxygen concentrator, when tested in accordance with the method in this subclause, shall be disclosed in the instructions for use:
1) for an oxygen concentrator with a continuous flow mode,
i) at a flowrate setting of 3 l/min, or
ii) the maximum flowrate setting if this is less than 3 l/min,
iii) as well as for the maximum flowrate setting if this setting is greater than or equal to 4 l/min;
and
2) for an oxygen concentrator with integrated oxygen conserving equipment function, at the maximum demand flow rate setting of normal use.
b) The instructions for use shall disclose:
1) the sound power level; and
2) the tested flowrates.

Check conformance with the following test:
c) For an oxygen concentrator with a continuous flow mode, place the oxygen concentrator on a sound-reflecting plane and attach 10 m ± 1 m of oxygen tubing.
d) Attach the standard resistance (as indicated in Figure 201.101) to the patient end of the oxygen tubing.
Set the oxygen concentrator to a flowrate of approximately 3 l/min or the maximum flowrate setting if this is less than 3 l/min.

Key
D is the internal diameter: (4 ± 0,1) mm
L is the length: (40 ± 1) mm
A is the angle (45 ± 1) °
Break all edges with 0,15 mm to 0,20 mm radius or 45° chamfer. Drawing is not to scale.

ISO 80601-2-69 Figure 21.101 Standard Resistance For Test Equipment. ISO 80601-2-69 — Medical electrical equipment — Part 2-69: particular requirements for basic safety and essential performance of oxygen concentrator equipment. This item is the Figure 21.101 gauge of that standard. Kingpo machines reference connectors and gauges in-house from hardened steel, inspects them against the figure before despatch and supplies them with a calibration certificate.

What it is used for

• Dimensional and mechanical checks on the connector under test
• Repeatable mating with the sample so results are comparable between laboratories

ISO 80601-2-69 Figure 21.101 defines the standard resistance used for testing.

Specification

How the test is run

1. Condition the reference connector and the sample together at the test temperature stated in the standard.
2. Mate the sample to the reference connector with the axial force or torque the standard specifies — never by hand feel alone.
3. Apply the test medium. Leakage tests use liquid under positive pressure or air under sub-atmospheric pressure; mechanical tests use a tensile or compressive load at a controlled rate.
4. Hold for the dwell time in the standard and record the reading.
5. Repeat for the number of samples the protocol calls for and report the worst case, not the average.

Reference connectors are inspection tools. Overriding tests and repeated axial-load tests wear them by design — plan replacement against test cycles.

Choosing the right figure

Annex C (and the equivalent annexes in the other parts) assigns one figure per reference connector, and each figure is certified for a specific set of tests. Picking the wrong one is the most common specification error in this category: the connectors look almost identical, but a figure that is certified for leakage is not the one you use for separation from axial load. Order against the figure number in your test protocol, not against the photograph.

What this is not

A reference connector is not a complete test system. Leakage, sub-atmospheric air leakage and separation-force tests need pressure, vacuum or force applied through ISO 80369-20 test apparatus. It is also not a simple go/no-go dimensional gauge: for a quick fit check on a conical fitting you want a plug gauge or a ring gauge, not a reference connector.

Frequently asked questions

Can I use one reference connector for several tests?

Only the tests the figure is certified for. Different figures are machined to different limits and, in some cases, to different materials, because the test loads differ.

Do you supply the test apparatus as well?

Yes. Kingpo builds the ISO 80369-20 apparatus — leakage, sub-atmospheric air leakage, separation force and unscrewing torque — alongside the reference connectors.

Is a calibration certificate included?

Yes, and we re-calibrate reference connectors you already hold.

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Send the standard, figure number and quantity to Kingpo technical sales for a quotation and delivery date.