Biomedical Engineering Reference
In-Depth Information
Table 4.1 International Organization for Standardization ISO 10993: Biological
Evaluation of Medical Devices Standard, by Parts
Part Title (publication year: status)
Focus
1
Evaluation and testing within a risk
management process (2009)
General instruction on how to use the
standard
2
Animal welfare requirements (2006)
General instruction on proper and
ethical use of animals in testing
3
Tests for genotoxicity (G),
carcinogenicity (C), and reproductive
toxicity (RT) (2003: CD)
In vitro and in vivo tests to assess the
materials capacity to cause G, C, and
RT
4
Selection of tests for interactions with
blood (2006: to be revised)
In vitro and in vivo tests to assess the
material/device interactions with
blood
5
Tests for in vitro cytotoxicity (1999:
under revision)
In vitro tests to assess the potential for
the material to cause a cytotoxic
response
6
Tests for local effects after
implantation (2007)
In vivo tests for general implantation
response
7
Ethylene oxide (ETO) sterilization
residuals (1995: under revision)
General instruction on safe ETO
sterilization practice
8 Withdrawn standard
NA
9
Framework for identification and
quantification of potential degradation
products (1999: under revision)
General instruction on chemical
characterization for material
degradation products
10
Tests for irritation and delayed-type
hypersensitivity (DTH) (2006: to be
revised)
In vivo tests for material-related
irritation and DTH
11
Tests for systemic toxicity (2006)
In vivo tests for material tissue toxicity
12
Sample preparation and reference
materials (2002: under revision)
General instruction on proper controls
and preparation of material samples
13
Identification and quantification of
degradation products from polymeric
medical devices (1998: under
revision)
In vitro analytical tests for chemical
characterization of polymeric materials
14
Identification and quantification of
degradation products from ceramics
(2001)
In vitro analytical tests for chemical
characterization of ceramic materials
15
Identification and quantification of
degradation products frommetals and
alloys (2000)
In vitro analytical tests for chemical
characterization of metallic materials
16
Toxicokinetic study design for
degradation products and leachables
(1997: to be revised)
In vivo tests for toxicokenetic
assessment of material degradation
products and leachables
17
Establishment of allowable limits for
leachable substances (2002)
Instruction on allowable limits of
leachable materials
18
Chemical characterization of materials
(2005)
In vitro analytical tests for chemical
characterization of materials
19
Physicochemical, morphological, and
topographical characterization of
materials (2006)
In vitro analytical tests for surface
analysis of materials
20
Principles and methods for
immunotoxicology testing of medical
devices (2006)
In vivo tests to assess material/device
immunotoxicity
