ISO - International Organization for Standardization - Page 199

Standards ISO - International Organization for Standardization - Page 199

ISO (International Organization for Standardization) is the world’s largest producer of optional international standards. International standards determine current specifications of products, services and certified methods, helping to streamline the industry. As they are created on the basis of international agreement, they assist in overcoming barriers in international trade.

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ISO 10993-4:2017-ed.3.0

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
(Évaluation biologique des dispositifs médicaux — Partie 4: Choix des essais pour les interactions avec le sang)

Standard published on 12.4.2017

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301.20 USD


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ISO 10993-4:2017-ed.3.0/Amd1:2025 Change

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
(Évaluation biologique des dispositifs médicaux — Partie 4: Choix des essais pour les interactions avec le sang — Amendement 1)

Change published on 8.1.2025

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27.20 USD


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ISO 10993-5:2009-ed.3.0

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
(Évaluation biologique des dispositifs médicaux — Partie 5: Essais concernant la cytotoxicité in vitro)

Standard published on 20.5.2009

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234.60 USD


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ISO/TR 10993-55:2023

Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
(Évaluation biologique des dispositifs médicaux — Partie 55: Étude interlaboratoire sur la cytotoxicité)

Standard published on 6.2.2023

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199.80 USD


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ISO 10993-6:2016-ed.3.0

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
(Évaluation biologique des dispositifs médicaux — Partie 6: Essais concernant les effets locaux apres implantation)

Standard published on 28.11.2016

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234.60 USD


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ISO 10993-7:2008-ed.2.0

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
(Évaluation biologique des dispositifs médicaux — Partie 7: Résidus de stérilisation a l´oxyde d´éthylene)

Standard published on 13.10.2008

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334.50 USD


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ISO 10993-7:2008-ed.2.0/Amd1:2019 Change

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
(Évaluation biologique des dispositifs médicaux — Partie 7: Résidus de stérilisation a l´oxyde d´éthylene — Amendement 1: titre manque)

Change published on 9.12.2019

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ISO 10993-7:2008-ed.2.0/Cor1:2009 Correction

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
(Évaluation biologique des dispositifs médicaux — Partie 7: Résidus de stérilisation a l´oxyde d´éthylene — Rectificatif technique 1)

Correction published on 12.11.2009

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ISO 10993-9:2019-ed.3.0

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
(Évaluation biologique des dispositifs médicaux — Partie 9: Cadre pour l´identification et la quantification des produits potentiels de dégradation)

Standard published on 26.11.2019

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98.40 USD


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ISO/IEC 10995-ed.2.0

Information technology - Digitally recorded media for information interchange and storage - Test method for the estimation of the archival lifetime of optical media

Standard published on 17.6.2011

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