Summary - Using ISO 10993
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Using ISO 10993 – Aside: There are 20 different parts of ISO 10993 To preview most ISO’s: https://www.iso.org/obp/ui/#home . Note that much of the article is on human/biological harm. I will skip these but can revisit these topics if desired. Eg. The three goals are that materials should not (i) produce adverse local or systemic effects, (ii) be carcinogenic, (iii) produce adverse reproductive and developmental effects. This entails cyto-, geno- toxicity, implantation, etc. . For devices involved in extracting body material, the operation testing methods are stated in ISO 10993-12: ( 37 ℃for 72 hrs; 50 ℃ for 72 hrs; 70 ℃ for 24 hrs ; 121 ℃ for 1 hr). There may need to be temperature and time adjustments with respect to prolonged contact. For example, permanent implants. Individual components may also need different, separate tests in addition to as a whole. . From the LLNA (Local Lymph Node Assay) and other tests, they all test for *biological effect*. Thus, a possible mode of qualification could speculatively be that if such an effect exists, then it’s chemically reactive, leaking, or having some failure mode? For example, pg 18, using a stimulation index ≥1.6, those are sensitizers. Thus, if doing some negative
description
Extracted out the more significant implications on the devices themselves than biological things.
Transcript of Summary - Using ISO 10993
Using ISO 10993 – Aside: There are 20 different parts of ISO 10993
To preview most ISO’s: https://www.iso.org/obp/ui/#home
. Note that much of the article is on human/biological harm. I will skip these but can revisit these topics if desired.
Eg. The three goals are that materials should not (i) produce adverse local or systemic effects, (ii) be carcinogenic, (iii) produce adverse reproductive and developmental effects. This entails cyto-, geno- toxicity, implantation, etc.
. For devices involved in extracting body material, the operation testing methods are stated in ISO 10993-12: (37℃ for 72hrs;50℃ for 72hrs ;70℃ for24 hrs;121℃ for 1hr).
There may need to be temperature and time adjustments with respect to prolonged contact. For example, permanent implants. Individual components may also need different, separate tests in addition to as a whole.
. From the LLNA (Local Lymph Node Assay) and other tests, they all test for *biological effect*. Thus, a possible mode of qualification could speculatively be that if such an effect exists, then it’s chemically reactive, leaking, or having some failure mode? For example, pg 18, using a stimulation index ≥1.6, those are sensitizers. Thus, if doing some negative checking, one could verify that there is no stimulation of index over 1.6?
. Biodegradation Testing is … I’m not sure if its in ISO 10993-1 because it says that the parameters affecting degradation should be described and documented. It doesn’t read in the manner that the methods of degradation are themselves described and documented in ISO 10993-1. But, it notes that in Secion 9, there are recommended elements, so ISO 10993-9 may be one of choice. (And a further note, ISO 10993-9 is a general form of ISO 10993-13,14,15, each of those is on a specific material, polymers, metals, ceramics. Also, I think 10993-12 may also be the next most useful. I used the ISO previewer linked at the top).
. The remainder of the article is just guides on how to conduct testing rather than details on what tests should be done.
