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SFS-EN ISO 10993-18:2020:en – Biological evaluation of medical devices. Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

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This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to ...
https://sales.sfs.fi/julkaisu.html.stx?id=896427

SFS-EN ISO 10993-6:2016:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 6: Implantista aiheutuneiden paikallisten muutosten testaaminen

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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 part ...
https://sales.sfs.fi/julkaisu.html.stx?id=455214

SFS-EN ISO 10993-14:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 14: Keraamisten laitteiden ja tarvikkeiden hajaantumistuotteiden määritys

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This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nat ...
https://sales.sfs.fi/julkaisu.html.stx?id=131536

SFS-EN ISO 10993-13:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 13: Polymeeriä sisältävien laitteiden ja tarvikkeiden hajaantumistuotteiden määritys

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ISO 10993-13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. ISO 10993-13:2010 describes two test methods to generate degradation products, an ...
https://sales.sfs.fi/julkaisu.html.stx?id=151194

SFS-EN ISO 10993-7:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 7: Etyleenioksidisteriloinnin jäämät

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ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, in ...
https://sales.sfs.fi/julkaisu.html.stx?id=118140

SFS-EN ISO 10993-4:2017:en – Biological evaluation of medical devices. Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

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ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the f ...
https://sales.sfs.fi/julkaisu.html.stx?id=569912

SFS-EN ISO 10993-3:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 3: Perimään, syövän syntyyn ja lisääntymiseen vaikuttavien omaisuuksien mittaaminen

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ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; ...
https://sales.sfs.fi/julkaisu.html.stx?id=308066