ISO 5834-4:2019 pdf free
ISO 5834-4:2019 pdf free.Implants for surgery一Ultra-high-molecular-weight polyethylene
Other modes of collection [i.e. percent reflection, attenuated total reflection (ATR), etc.], and aperture and increment sizes may be used to generate the sample’s absorption spectrum provided they can be demonstrated to produce equivalent results. Too large an aperture can result in a loss of profile accuracy.
When a Fourier transform infrared (FTIR) spectrometer is used, a minimum of 32 scans shall be collected per spectrum unless the reproducibility of the results can be justified as described in ASTM F2102, in which case a minimum of 8 scans shall be collected. The FTIR instrument and sample compartment should be purged with a moisture- and carbon-dioxide-free inert gas (e.g. nitrogen,helium, or argon) to minimize spectral interference from these components.
Using a microtome, or other appropriate device, prepare a thin slice of the sample 150 μm to 250 μm thick. The slice shall typically be taken near the centre of the sample’s articular surface or the surface of interest. The orientation of the slice shall typically be perpendicular to the articular surface or the surface of interest.
If the samples have been taken from retrieved devices or in-vitro specimens which have been exposed to lipids, the retrieved devices shall be submerged in a reagent (heptane or hexane) to extract lipids from the polymer that interfere with the carbonyl peak absorptions.
The test film (slice) shall be first configured in the spectrometer (after an appropriate background spectrum has been collected) so that the aperture is positioned over the first 200 um of the film starting at the articular surface. Subsequent spectra shall be collected sequentially at about 200 μum increments from the articular surface across the width of the film to the opposite surface. Larger increment sizes may be used, however too large an increment size can result in a loss of profile accuracy.
Prepare the infrared spectrometer for collection of a transmission absorption spectrum according to the manufacturer’s recommendations and the conditions described in 5.2.1. Collect the sequence of spectra according to 7.2.ISO 5834-4 pdf free download.