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Norm

ÖNORM EN ISO 10993-6

Issue date: 2017 06 15

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part o...
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Publisher:
Austrian Standards International
Format:
Digital | 44 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are - solid and non-absorbable, - non-solid, such as porous materials, liquids, gels, pastes, and particulates, and - degradable and/or absorbable, which may be solid or non-solid. The test sample 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 sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might 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 sample to that caused by control materials used in medical devices whose 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 absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined. This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.
ÖNORM EN ISO 10993-6
2017 06 15
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
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ÖNORM EN ISO 10993-6
2009 09 15
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ÖNORM EN ISO 10993-6
2007 08 01
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ÖNORM EN 30993-6
1995 06 01
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ISO 10993-1:2003
Issue date : 2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
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ISO 10993-2:2006
Issue date : 2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
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ISO 10993-4:2017
Issue date : 2017 04 12
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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ISO 10993-16:2017
Issue date : 2017 05 16
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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ISO 10993-6:2016
Issue date : 2016 11 28
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation