Biocompatibility Hub
  • 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

ISO 10993-3 2014
GENETOX, CARCINOGENICITY AND REPRODUCTIVE TOXICITY

The Basic Study design requirements
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.

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.
Powered by Create your own unique website with customizable templates.
  • 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