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ISO 10993-3 1993
Genetox, Carcinogenicity and Reproductive Toxicity

The Basic Study design requirements
This document directs the reader to OECD standards.

Typical In Vitro genotoxicity tests are listed

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

And others that have since been deleted

Typical In Vivo Genotoxicity tests are listed

OECD 474 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf

OECD 475 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf

OECD 478 was updated after the ISO document was published  http://www.oecd.org/env/ehs/testing/OECD_TG478_Revision_Sept_2013.pdf

OECD 483  was updated after the ISO document was published http://www.oecd.org/chemicalsafety/testing/TG-483-Mammalian-Spermatogonial-Chromosomal-Aberrations-Revision-Sep-23-2013-CLEAN-FM-bis.pdf

OECD 484  was updated after the ISO document was published http://www.oecd.org/env/ehs/testing/TG487%20Oct%202012%20updated%2029oct.pdf

OECD 485 http://www.oecd-ilibrary.org/docserver/download/9748501e.pdf?expires=1465236843&id=id&accname=guest&checksum=2CE62F9561F95CE93AB3BB6B38B2E7DD

Typical Carcinogenicity tests are listed

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

Typical Reproductive toxicity tests are listed

OECD 414 was updated after the ISO document was published 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

A few quick definitions 

Genotoxicity test means a test that will determine gene mutations, changes in chromosome stucture or change to the DNA.

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.

Reproductive and developmental tests evaluate the potential of devices, materials, or extracts to affect reproductive function, embryonic development and prenatal and postnatal development.

Maximum implantable dose is the largest dose an animal can tolerate without it causing physical or mechanical effects.

Energy depositing devices exert their therapeutic or diagnostic effects by the absorption of electromagnetic, ionic, or ultrasonic radiation.

General Genotoxicity

The battery of tests should contain 3 tests that should cover the 3 levels of genetic mateirals, DNA, gene mutation, and chromosome aberration.

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.
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search