Hakutulokset
Hakutulokset
Haulla "109" löytyi 330 tulosta.
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 ...
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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 ...
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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 ...
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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
ISO 10939:2017, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.
ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic eq ...
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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
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 ...
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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
ISO 10944:2009, together with ISO 15004-1, specifies minimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in differe ...
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ISO 10940:2009, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis.
ISO 10940:2009 takes ...
https://sales.sfs.fi/julkaisu.html.stx?id=138861
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)
Verkkokaupan tuotteet
SFS-EN ISO 10993-6:2016:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 6: Implantista aiheutuneiden paikallisten muutosten testaaminen
Verkkokaupan tuotteet
SFS-EN ISO 10993-14:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 14: Keraamisten laitteiden ja tarvikkeiden hajaantumistuotteiden määritys
Verkkokaupan tuotteet
SFS-EN ISO 10993-13:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 13: Polymeeriä sisältävien laitteiden ja tarvikkeiden hajaantumistuotteiden määritys
Verkkokaupan tuotteet
SFS-EN ISO 10939:2017:en – Silmälääketieteelliset instrumentit. Valomikroskoopit
Verkkokaupan tuotteet
SFS-EN ISO 10993-7:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 7: Etyleenioksidisteriloinnin jäämät
Verkkokaupan tuotteet
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)
Verkkokaupan tuotteet
SFS-EN ISO 10993-3:en – Terveydenhuollon laitteiden ja tarvikkeiden biologinen arviointi. Osa 3: Perimään, syövän syntyyn ja lisääntymiseen vaikuttavien omaisuuksien mittaaminen
Verkkokaupan tuotteet
SFS-EN ISO 10944:en – Silmälääketieteen instrumentit. Synoptoforit
Verkkokaupan tuotteet
SFS-EN ISO 10940:en – Silmälääketieteen instrumentit. Silmänpohjakamerat
Verkkokaupan tuotteet