Biomedical Engineering Reference
In-Depth Information
Norm
number
Date/Up
dated/
amendment
Part
Object
Tests
ISO 10993-1
2009
1
Biological
evaluation of
medical devices
Evaluation and testing
in the risk management
process
ISO 10993-2
2006
2
Biological
evaluation of
medical devices
Animal welfare
requirements
ISO 10993-3
2003
3
Biological
evaluation of
medical devices
Tests for genotoxicity,
carcinogenicity and
reproductive toxicity
ISO 10993-4
2002
Amd
1:2006
4
Biological
evaluation of
medical devices
Selection of tests for
interactions with blood
ISO 10993-5
2009
5
Biological
evaluation of
medical devices
Tests for
in vitro
cytotoxicity
ISO 10993-6
2007
6
Biological
evaluation of
medical devices
Tests for local effects
after implantation
ISO 10993-7
2008
Biological
evaluation of
medical devices
Ethylene oxide
sterilization residuals
ISO 10993-8
2001
8
Biological
evaluation of
medical devices
Selection of reference
materials
ISO 10993-9
1999
9
Biological
evaluation of
medical devices
Framework for
identification and
quantification of
potential degradation
products
ISO 10993-
10
10:2010
Part 10:
Biological
evaluation of
medical devices
Tests for irritation and
delayed type
hypersensitivity
ISO 10993-
11
2006
11
Biological
evaluation of
medical devices
Tests for systemic
toxicity
Sample preparation and
reference materials
(available
in English only)
ISO 10993-
12
2012
12
Biological
evaluation of
medical devices
