This document directs the reader to OECD standards.
OECD 414 http://www.oecd-ilibrary.org/docserver/download/9741401e.pdf?expires=1465237113&id=id&accname=guest&checksum=98F76117DDEB0FAE06C8B8CBACB0BE9A
OECD 415 http://www.oecd-ilibrary.org/docserver/download/9741501e.pdf?expires=1465237174&id=id&accname=guest&checksum=A94F6B9C220AC0F3D032D68911136501
OECD 416 http://www.oecd-ilibrary.org/docserver/download/9741601e.pdf?expires=1465351143&id=id&accname=guest&checksum=6E62FE6D35EAC524E914985FC5492413
OECD 421 http://www.oecd.org/chemicalsafety/risk-assessment/1948474.pdf
OECD 451 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745101e.pdf?expires=1465236964&id=id&accname=guest&checksum=B232266A151EA20354D82D1088553DEB
OECD 453 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745301e.pdf?expires=1465237013&id=id&accname=guest&checksum=31427D06039676195EFC0FEF7E875EB9
OECD 471 http://www.oecd.org/chemicalsafety/risk-assessment/1948418.pdf
OECD 473 http://www.oecd.org/chemicalsafety/risk-assessment/1948434.pdf
OECD 476 http://www.oecd.org/chemicalsafety/risk-assessment/1948426.pdf
A few quick definitions
Carcinogenicity test means a test that determines the tumorigenic potential of devices, materials or extracts to either single or multiple exposures over the lifespan of an animal.
OECD 414 http://www.oecd-ilibrary.org/docserver/download/9741401e.pdf?expires=1465237113&id=id&accname=guest&checksum=98F76117DDEB0FAE06C8B8CBACB0BE9A
OECD 415 http://www.oecd-ilibrary.org/docserver/download/9741501e.pdf?expires=1465237174&id=id&accname=guest&checksum=A94F6B9C220AC0F3D032D68911136501
OECD 416 http://www.oecd-ilibrary.org/docserver/download/9741601e.pdf?expires=1465351143&id=id&accname=guest&checksum=6E62FE6D35EAC524E914985FC5492413
OECD 421 http://www.oecd.org/chemicalsafety/risk-assessment/1948474.pdf
OECD 451 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745101e.pdf?expires=1465236964&id=id&accname=guest&checksum=B232266A151EA20354D82D1088553DEB
OECD 453 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745301e.pdf?expires=1465237013&id=id&accname=guest&checksum=31427D06039676195EFC0FEF7E875EB9
OECD 471 http://www.oecd.org/chemicalsafety/risk-assessment/1948418.pdf
OECD 473 http://www.oecd.org/chemicalsafety/risk-assessment/1948434.pdf
OECD 476 http://www.oecd.org/chemicalsafety/risk-assessment/1948426.pdf
A few quick definitions
Carcinogenicity test means a test that determines the tumorigenic potential of devices, materials or extracts to either single or multiple exposures over the lifespan of an animal.
Energy depositing devices exert their therapeutic or diagnostic effects by the absorption of electromagnetic, ionic, or ultrasonic radiation.
Genotoxicity test means a test that will determine gene mutations, changes in chromosome stucture or change to the DNA.
Maximum tolerated dose is the largest dose an animal can tolerate without any adverse effects
Reproductive and developmental tests evaluate the potential of devices, materials, or extracts to affect reproductive function, embryonic development and prenatal and postnatal development.
Test sample preparation residual, extractables, leachables or biodegradable device materials that are resuspended in a vehicle compatible with the test system.
General Genotoxicity
The strategy is directed to an all in vitro approach with two options, the first which constitutes OECD 471, 473, and 476. Or the second option that is OECD 471 and OECD 476 expanded to address gene mutagenicity and chromosome damage.
If In Vivo genotoxicity tests are conducted these are suggested
OECD 474 http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf
OECD 475 http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf
OECD 486 http://www.oecd-ilibrary.org/docserver/download/9748601e.pdf?expires=1465351982&id=id&accname=guest&checksum=D79DFEF9BCF0504B5A0B9F298AC61CE2
The final finished product should be tested and 2 extracts should be used, one a physiologic medium and one a solvent which is compatible with the test system.
General Carcinogenicity
Conditions that may suggest the need for carcinogenicity include; resorbable materials, when there has been positive genotoxicity tests, permanent internal implants.
The final finished devce should be tested, with 2 dose levels. A maximum implantable dose and half that.
General Reproductive toxicity
Conditions that suggest the need for reproductive toxicity tests include, intrauterine devices, energy depositing devices and permanent reproductive contacting implants. Also unknown resorbable or leachable products.
Informative annexes B and C are very informative and should be read prior to designing these types of studies even today.
Genotoxicity test means a test that will determine gene mutations, changes in chromosome stucture or change to the DNA.
Maximum tolerated dose is the largest dose an animal can tolerate without any adverse effects
Reproductive and developmental tests evaluate the potential of devices, materials, or extracts to affect reproductive function, embryonic development and prenatal and postnatal development.
Test sample preparation residual, extractables, leachables or biodegradable device materials that are resuspended in a vehicle compatible with the test system.
General Genotoxicity
The strategy is directed to an all in vitro approach with two options, the first which constitutes OECD 471, 473, and 476. Or the second option that is OECD 471 and OECD 476 expanded to address gene mutagenicity and chromosome damage.
If In Vivo genotoxicity tests are conducted these are suggested
OECD 474 http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf
OECD 475 http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf
OECD 486 http://www.oecd-ilibrary.org/docserver/download/9748601e.pdf?expires=1465351982&id=id&accname=guest&checksum=D79DFEF9BCF0504B5A0B9F298AC61CE2
The final finished product should be tested and 2 extracts should be used, one a physiologic medium and one a solvent which is compatible with the test system.
General Carcinogenicity
Conditions that may suggest the need for carcinogenicity include; resorbable materials, when there has been positive genotoxicity tests, permanent internal implants.
The final finished devce should be tested, with 2 dose levels. A maximum implantable dose and half that.
General Reproductive toxicity
Conditions that suggest the need for reproductive toxicity tests include, intrauterine devices, energy depositing devices and permanent reproductive contacting implants. Also unknown resorbable or leachable products.
Informative annexes B and C are very informative and should be read prior to designing these types of studies even today.
