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About This Item

 

Full Description

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.
 

Document History

  1. BS EN ISO 10993-6:2016


    Biological evaluation of medical devices-Tests for local effects after implantation

    • Most Recent
  2. BS EN ISO 10993-6:2009

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    Biological evaluation of medical devices-Tests for local effects after implantation

    • Historical Version
  3. BS EN ISO 10993-6:2007


    Biological evaluation of medical devices-Tests for local effects after implantation

    • Historical Version
  4. BS EN 30993-6:1995


    Biological evaluation of medical devices-Tests for local effects after implantation

    • Historical Version
  5. BS 5736-2:1990


    Evaluation of medical devices for biological hazards-Methods of testing by tissue implantation

    • Historical Version
  6. BS 5736-2:1981


    Evaluation of medical devices for biological hazards-Method of testing by tissue implantation

    • Historical Version