Definitions:
Acute toxicity: single or multiple doses in 24 hours.
Subacute: single or multiple doses from 14 to 28 days.
Subchronic: single or multiple doses usually 90 days, not more than 10% of lifespan
Testing should be performed on the final product. Occasionally, investigate individual parts of the finished product.
Much discussion on how to test materials as they exist or in dilutions or suspensions.
Method of extraction contained in the main body of the document.
A full page and a half on extraction specifics.
Thickness less than 0.5 mm uses 6cm2 per 1 ml
Thickness greater than 0.5 mm uses 3cm2 per 1 ml
Test article should be tested subdivided, or intact. Should follow suggested ratios, or not.
Extract vessels should not adulterate the extract.
Use an extraction vehicle, that represents the extremes of solubility ranging from saline thru refined oil to DMSO or alcohol or polyethylene glycol 400 (PEG).
Extraction conditions :
37 +/- 2 oC for 72 +/- 2 hours
50 +/- 2 oC for 72 +/- 2 hours
70 +/- 2 oC for 24 +/- 2 hours
121 +/- 2 oC for 1 +/- 0.2 hours
A statement that 37 +/- 2 oC for 72 +/- 2 hours is suitable for most devices. But higher temperatures for shorter times could be considered.
Conditions should mimic clinical expectations. The conditions should not cause physical change to the device.
Test conduct
No methods directly specified. Instead this guidance references; ASTM, Official journal of European Communities, OECD, USP, US FDA and US EPA, for Acute, Subacute, and Subchronic toxicities of the Oral, Dermal, Inhalation, Intravenous and Intraperitoneal applications.
A statement that chronic toxicity and carcinogenicity are rarely a concern for medical devices.
Pyrogenicity
For endotoxin and non-endotoxin sources of pyrogenicity follow USP XXII rabbit pyrogen.
For endotoxin only sources of pyrogenicity follow USP XXII Bacterial endotoxin or EP Part V.2.1.9 Pyrogens.
Acute toxicity: single or multiple doses in 24 hours.
Subacute: single or multiple doses from 14 to 28 days.
Subchronic: single or multiple doses usually 90 days, not more than 10% of lifespan
Testing should be performed on the final product. Occasionally, investigate individual parts of the finished product.
Much discussion on how to test materials as they exist or in dilutions or suspensions.
Method of extraction contained in the main body of the document.
A full page and a half on extraction specifics.
Thickness less than 0.5 mm uses 6cm2 per 1 ml
Thickness greater than 0.5 mm uses 3cm2 per 1 ml
Test article should be tested subdivided, or intact. Should follow suggested ratios, or not.
Extract vessels should not adulterate the extract.
Use an extraction vehicle, that represents the extremes of solubility ranging from saline thru refined oil to DMSO or alcohol or polyethylene glycol 400 (PEG).
Extraction conditions :
37 +/- 2 oC for 72 +/- 2 hours
50 +/- 2 oC for 72 +/- 2 hours
70 +/- 2 oC for 24 +/- 2 hours
121 +/- 2 oC for 1 +/- 0.2 hours
A statement that 37 +/- 2 oC for 72 +/- 2 hours is suitable for most devices. But higher temperatures for shorter times could be considered.
Conditions should mimic clinical expectations. The conditions should not cause physical change to the device.
Test conduct
No methods directly specified. Instead this guidance references; ASTM, Official journal of European Communities, OECD, USP, US FDA and US EPA, for Acute, Subacute, and Subchronic toxicities of the Oral, Dermal, Inhalation, Intravenous and Intraperitoneal applications.
A statement that chronic toxicity and carcinogenicity are rarely a concern for medical devices.
Pyrogenicity
For endotoxin and non-endotoxin sources of pyrogenicity follow USP XXII rabbit pyrogen.
For endotoxin only sources of pyrogenicity follow USP XXII Bacterial endotoxin or EP Part V.2.1.9 Pyrogens.
