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
OECD 478 http://www.oecd.org/env/ehs/testing/TG487%20Oct%202012%20updated%2029oct.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.
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
OECD 478 http://www.oecd.org/env/ehs/testing/TG487%20Oct%202012%20updated%2029oct.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 address two major classes of genetic damage, gene mutations and chromosomal damage. A test battery should consiste of OECD 471, and 473, or 476, or OECD 487.
If In Vivo genotoxicity tests are conducted these are suggested to be performed on two extracts polar dosed intravenously and nonpolar which is dosed intraperitoneally.
OECD 474 http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf
OECD 475 http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf
OECD 488 Now deleted
General Carcinogenicity
Conditions that may suggest the need for carcinogenicity include; resorbable materials, when there has been positive genotoxicity tests, permanent internal implants. And tests should not be conducted if there is adequate human data, the materials are expected to give rise to solid state carcinogenesis, or if the data can be expected to be suspect. The test methods should be OECD 451 or 453.
The dose should be a 100 fold safety factor.
A discussion about the benefits of the transgenic mouse model which ends before the onset of solid state carcinogenesis.
General Reproductive toxicity
Conditions that suggest the need for reproductive toxicity tests include, intrauterine devices, energy depositing devices and prolonged or permanent reproductive contacting implants. Also unknown resorbable or leachable products.
Informative annex A is a lengthy one which includes a decision try on how to prepare the sample and 3 different decisions in the tree.
Informative annex B is a flowchart for follow up evaluation.
Informative annexes C, D, E and F are just informative.
The strategy is directed to address two major classes of genetic damage, gene mutations and chromosomal damage. A test battery should consiste of OECD 471, and 473, or 476, or OECD 487.
If In Vivo genotoxicity tests are conducted these are suggested to be performed on two extracts polar dosed intravenously and nonpolar which is dosed intraperitoneally.
OECD 474 http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf
OECD 475 http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf
OECD 488 Now deleted
General Carcinogenicity
Conditions that may suggest the need for carcinogenicity include; resorbable materials, when there has been positive genotoxicity tests, permanent internal implants. And tests should not be conducted if there is adequate human data, the materials are expected to give rise to solid state carcinogenesis, or if the data can be expected to be suspect. The test methods should be OECD 451 or 453.
The dose should be a 100 fold safety factor.
A discussion about the benefits of the transgenic mouse model which ends before the onset of solid state carcinogenesis.
General Reproductive toxicity
Conditions that suggest the need for reproductive toxicity tests include, intrauterine devices, energy depositing devices and prolonged or permanent reproductive contacting implants. Also unknown resorbable or leachable products.
Informative annex A is a lengthy one which includes a decision try on how to prepare the sample and 3 different decisions in the tree.
Informative annex B is a flowchart for follow up evaluation.
Informative annexes C, D, E and F are just informative.
