2013/05/02 ISO 10993-1:2009 & FDA endpoints for consideration The following table provides a framework for the development of a biocompatibility evaluation. Different biological endpoints may require evaluation for particular medical devices, including either additional or fewer endpoints than indicated. ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing ISO 14971, Medical devices — Application of risk management to medical devices 3 Terms and definitions For the purposes of this3.1 ISO 10993-10:2002/Amd 1:2006 Tilbaketrukket Antall sider: 67 Pris: NOK 2 031,00 (eks. mva) NOK 2 538,75 (ink. mva) Omfang: Komité: SN/K 109 Fastsatt: 2010-07-27 ICS: 11.100.20 - Biologisk evaluering av medisinsk utstyr
2018/11/29
2020/05/28
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Europastandarden EN ISO 10993-10:2013 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 10993-10:2013. Denna standard ersätter SS-EN ISO 10993-10:2010, utgåva 4.
ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing ISO 14971, Medical devices — Application of risk management to medical devices 3 Terms and definitions For the purposes of this3.1 ISO 10993-10:2002/Amd 1:2006 Tilbaketrukket Antall sider: 67 Pris: NOK 2 031,00 (eks. mva) NOK 2 538,75 (ink. mva) Omfang: Komité: SN/K 109 Fastsatt: 2010-07-27 ICS: 11.100.20 - Biologisk evaluering av medisinsk utstyr 2020/05/28
This part of
International Standard IS0 10993-l 1 was prepared by Technical Com- mittee lSO/TC 194, Biological evaluation of medical devices. IS0 10993 consists of the following parts, under the general title Biological
This part of
ISO 10993-10，ISO 10993-12），DIN EN 30993-1：1994，DIN EN ISO 7405：1998 “歯科―歯科用医療機器の生体安全性の前臨床評価―歯科材料の試験方法”に基づいて実施した。 試験はRCC研究所(スイス)とBSL Bioservice 試験は
2012/03/07
The primary aim of this document is the protection of humans from potential biological risks arising from the use of medical devices. It is compiled from numerous International and national standards and guidelines concerning the biological evaluation of medical devices. Aug 28, 2019 · ISO 10993-1: 2018, Annex A (cont.) Table A.1 NOT recognized by CDRH – see 2016 CDRH Biocomp Guidance Attachment A = consistent w/2016 Guidance; = not consistent w/2016 Guidance