Hi Could someone help me converting ETO residual limits from PPM to mg please. Our overseas contract manufacturer (CM) utilises IS10150 (Indian Standard) that provides EO, ECH, EG limits in PPM. Where as ISO 10993-7: 2008 list the quantities in mg. Our CM states that Indian standard is more stringent and listed below rationale;
EO ECH EG
AS PER IS 10150 PPM 25 25 250
AS PER ISO 10993-7 MG 60 60 NA
EXTRACT 5 ML 12 12
0.1 % MG 1.2 1.2
MCG 1200 1200
PPM 1200 1200
i.e. the Indian standard far more stringent than ISO10993-7: 2008. However, I am unable to understand the logic. The questioned device is class IIa simple IV set that come in contact with patient for Prolonged Exposure (>24 hours to <30 days) hence the ISO 10993-7: 2008 limit taken as 60mg.
Any help would be much appreciated. Thanks
EO ECH EG
AS PER IS 10150 PPM 25 25 250
AS PER ISO 10993-7 MG 60 60 NA
EXTRACT 5 ML 12 12
0.1 % MG 1.2 1.2
MCG 1200 1200
PPM 1200 1200
i.e. the Indian standard far more stringent than ISO10993-7: 2008. However, I am unable to understand the logic. The questioned device is class IIa simple IV set that come in contact with patient for Prolonged Exposure (>24 hours to <30 days) hence the ISO 10993-7: 2008 limit taken as 60mg.
Any help would be much appreciated. Thanks
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