BS EN ISO 10993-6:2009 specifies test methods for the assessment of the local effects after implantation of
biomaterials intended for use in medical devices.
BS EN ISO 10993-6:2009 applies to materials that are:
- solid and non-biodegradable;
- degradable and/or resorbable;
- non-solid, such as porous materials, liquids, pastes and particulates.
The test specimen is implanted into a site and animal species appropriate for the evaluation of the biological
safety of the material. These implantation tests are not intended to evaluate or determine the performance of
the test specimen in terms of mechanical or functional loading. This part of ISO 10993 may also be applied to
medical devices that are intended to be used topically in clinical indications where the surface or lining may
have been breached, in order to evaluate local tissue responses.
The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that
caused by control materials used in medical devices of which the clinical acceptability and biocompatibility
characteristics have been established. The objective of the test methods is to characterize the history and
evolution of the tissue response after implantation of a medical device/biomaterial including final integration or
resorption/degradation of the material. In particular for degradable/resorbable materials the degradation
characteristics of the material and the resulting tissue response should be determined.
BS EN ISO 10993-6:2009 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity.
However, the long-term implantation studies intended for evaluation of local biological effects may provide
insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the
requirements of BS EN ISO 10993-6:2009.
Cross References:ISO 10993-1:2003
ISO 10993-2
ISO 10993-11
ISO 10993-12
ISO 10993-16
ISO 5832-1
ISO 5832-2
ISO 5832-3
ISO 5832-4
ISO 5832-5
ISO 5832-6
ISO 5832-7
ISO 5832-8
ISO 5834-2
ISO 6474
ISO 7405
ISO 10993-9
ASTM F748
ASTM F763
ASTM F981
ASTM F1983
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 760 KB |
| ISBN(s) : | 9780580656620 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 32 |
| Product Code(s) : | 30194453, 30194453 |
| Published : | 06/30/2009 |
| Same As : | BS EN ISO 10993-6:2009 |
