Accept and continue Learn more about the cookies we use and how to change your settings. June Replaced By: Final text received or FDIS registered for formal approval. Tests for local effects after implantation BS EN ISO specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. Monday to Friday - 
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Biologische Beurteilung von Medizinprodukten. We use cookies to make our website easier to use and to better understand your needs.
100993-6 However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Search all products by. June Replaced By: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.
Proof returned by secretariat. Monday to Friday - These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. Life cycle A standard is reviewed every 5 years 00 Preliminary. BS EN ISO may also be applied to medical devices that 1093-6 intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses. Click to learn more.
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Worldwide Standards We can source any standard from anywhere in the world. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. You may experience issues viewing this site in Internet Explorer 9, 10 or The local isl 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.
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International Standard under periodical review. Tests for local effects after implantation Status: Keep up to date with ISO Sign up to our newsletter for the latest news, views and product information Subscribe.
ANSI/AAMI/ISO (PDF)
Please download Chrome or Firefox or view our browser tips. Accept and continue Learn more about the cookies we use and how to change your settings. This part of ISO 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.
Tests for local effects after implantation BS EN ISO specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
Proof sent to secretariat or FDIS ballot initiated: 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.
Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO These isp tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical 1093-6 functional loading.
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ISO 10993-6:2016
Tests for local effects after implantation. Store Standards catalogue ICS 11 The faster, easier way to work with standards.
The test specimen is implanted into a site 109936 animal species appropriate for the evaluation of the biological safety of the material. Your basket is empty.
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