Biomedical Engineering Reference
In-Depth Information
Device guidelines: FDA
FDA, Device Advice, Clinical Trials and IDE Guidance Documents, http://www.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfIDE/da_ide_topic.cfm
FDA, Device Advice, http://www.fda.gov/cdrh/devadvice/
FDA, Design Control Guidance for Medical Device Manufactures (1997), http://
www.fda.gov/cdrh/comp/designgd.html
FDA, Guidance for the Medical Device Industry on PMA Shell Development and
Modular Review (1998), http://www.fda.gov/ohrms/dockets/98fr/980896gd.pdf
FDA, Medical Device Reporting Guidance Documents, http://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfTopic/topicindex/guidance.cfm?topic=224
Device guidelines: ISO
AAMI TIR19:1998 and TIR 19/A1:1999, Guidance for ANSI/AAMI/ISO
10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide
sterilization residuals.
ANSI/AAMI BE78:2002, Biological evaluation of medical devices - Part 10: Tests
for irritation and delayed type hypersensitivity.
ANSI/AAMI/ISO 10993-1:1997, Biological evaluation of medical devices-Part 1:
Evaluation and testing.
ANSI/AAMI/ISO 10993-2:1993/(R)2001, Biological evaluation of medical
devices - Part 2: Animal protection requirements.
ANSI/AAMI/ISO 10993-3:1993, Biological evaluation of medical devices - Part 3:
Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
ANSI/AAMI/ISO 10993-4:2002, Biological evaluation of medical devices - Part 4:
Selection of tests for interaction with blood.
ANSI/AAMI/ISO 10993-5:1999, Biological evaluation of medical devices - Part 5:
Tests for cytotoxicity,
in vitro
methods.
ANSI/AAMI/ISO 10993-6:1995/(R)2001, Biological evaluation of medical
devices - Part 6: Tests for local effects after implantation
ANSI/AAMI/ISO 10993-7:1995/(R)2001, Biological evaluation of medical
devices - Part 7: Ethylene oxide sterilization residuals.
ANSI/AAMI/ISO 10993-8:2000, Biological evaluation of medical devices - Part 8:
Selection and qualifi cation of reference materials for biological tests.
ANSI/AAMI/ISO 10993-9:1999, Biological evaluation of medical devices - Part 9:
Framework for identifi cation and quantifi cation of potential degradation
products.
ANSI/AAMI/ISO 10993-11:1993, Biological evaluation of medical devices - Part 11:
Tests for systemic toxicity.
ANSI/AAMI/ISO 10993-12:2002, Biological evaluation of medical devices - Part 12:
Sample preparation and reference materials.
ANSI/AAMI/ISO 10993-13:1999, Biological evaluation of medical devices - Part 13:
Identifi cation and quantifi cation of degradation products from polymeric
devices.
ANSI/AAMI/ISO 10993-14:2001, Biological evaluation of medical devices - Part 14:
Identifi cation and quantifi cation of degradation products from ceramics.
