Standard Swedish standard · SS-EN ISO 10993-6:2017

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

Status: Valid

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Standard Swedish standard · SS-EN ISO 10993-6:2017

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
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Scope
ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. ISO 10993-6:2016 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.

Subjects

General (11.020) Biological evaluation of medical devices (11.100.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 10993-6:2017

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

Price: 2 112 SEK
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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8024379

Edition: 3

Approved: 1/9/2017

No of pages: 48

Replaces: SS-EN ISO 10993-6:2009