Standard Svensk standard · SS-EN ISO 10993-6:2007

Biologisk värdering av medicintekniska produkter - Del 6: Prövning för lokala reaktioner efter implantation (ISO 10993-6:2007)

Status: Upphävd

· Ersätts av: SS-EN ISO 10993-6:2009
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Standard Svensk standard · SS-EN ISO 10993-6:2007

Biologisk värdering av medicintekniska produkter - Del 6: Prövning för lokala reaktioner efter implantation (ISO 10993-6:2007)
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Omfattning
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-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. 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 may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of this part of ISO 10993.

Ämnesområden

Medicin allmänt (11.020) Biologisk värdering av medicintekniska produkter (11.100.20)


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Standard Svensk standard · SS-EN ISO 10993-6:2007

Biologisk värdering av medicintekniska produkter - Del 6: Prövning för lokala reaktioner efter implantation (ISO 10993-6:2007)
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Pris: 1 152 SEK
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Produktinformation

Språk: Engelska

Framtagen av: Biologisk säkerhet, SIS/TK 340/AG 02

Internationell titel: Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Artikelnummer: STD-60936

Utgåva: 1

Fastställd: 2007-05-04

Antal sidor: 26

Ersätter: SS-EN 30993-6

Ersätts av: SS-EN ISO 10993-6:2009