Biomedical Engineering Reference
In-Depth Information
Table 9.8
A summary of global device regulatory authorities and their internet
access sites
Organization or
publication
Web address
Sample main topics
CE marketing
www.sos.se/sose/nt/
medtekn/cemark.
htm
This is a Swedish government
site which provides specifi c
information regarding CE
marketing, which is necessary
to market medical devices in the
European Community member
nations
European
Union (EU)
http://europa.eu.int/
This is a multi-lingual gateway to
information about all activities
of the European Union.
Health Canada
www.hc-sc.gc.ca
Provides useful information about
the regulation of all medical
products in Canada, and other
Canadian government health
programs
Medical device
agency
www.
medical-devices.
gov.uk
Provides useful information
about the regulation of medical
devices in the United Kingdom
National
Institute of
Health
Sciences -
Japan
www.nihs.go.jp
Provides useful information
about the regulation of medical
devices and pharmaceutical
products in Japan
Therapeutic
Goods
Administration
www.health.gov.au/
tga
Provides useful information about
the regulation of medical devices
and pharmaceutical products in
Australia
Table 9.9
Sensitization test procedures required by ISO 10993-10
ISO 10993-10
Sample preparation:
Extraction in polar and/or non-polar solvents.
Extraction ratio:
Extraction ratio is dependent on thickness of device or representative portion.
Extract used for testing. If extraction is not possible, the adjuvant and patch test
can be utilized.
Acute systemic toxicity
: This estimates the harmful effects of either single
or multiple exposures to test materials and/or extracts, in an animal model,
during a period of less than 24 h. The ISO and ASTM procedures are pre-
sented in Table 9.13. It should be noted that the acute systemic toxicity assay
is generally no longer required.
