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DIN EN ISO 10993-6

Biologische Beurteilung von Medizinprodukten - Teil 6: Pruefungen auf lokale Effekte nach Implantationen (ISO 10993-6:2016); Deutsche Fassung EN ISO 10993-6:2016

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Organization: DIN
Publication Date: 1 September 2017
Status: active
Page Count: 47
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

DIN EN ISO 10993-6
September 1, 2017
Biologische Beurteilung von Medizinprodukten - Teil 6: Pruefungen auf lokale Effekte nach Implantationen (ISO 10993-6:2016); Deutsche Fassung EN ISO 10993-6:2016
A description is not available for this item.
DIN EN ISO 10993-6
December 1, 2014
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2014); German version prEN ISO 10993-6:2014
A description is not available for this item.
DIN EN ISO 10993-6
August 1, 2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2009
A description is not available for this item.
DIN EN ISO 10993-6/A1
February 1, 2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); English version prEN ISO 10993-6:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 10993-6
August 1, 2007
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2007
A description is not available for this item.
DIN EN ISO 10993-6
April 1, 2005
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2005); German version prEN ISO 10993-6:2005
A description is not available for this item.
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References

This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
This document references:
ISO 5832-4 - Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
Published by ISO on September 15, 2014
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, cobaltchromium- molybdenum casting alloy for use in the manufacture of surgical implants. NOTE The...
This document references:
ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by ISO on May 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
This document references:
ISO 5832-1 - Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
Published by ISO on July 15, 2016
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. NOTE 1 The mechanical properties...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document is referenced by:
DIN EN ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Published by DIN on December 1, 2017
Dieses Dokument legt allgemeine Anforderungen zur Beurteilung der Wechselwirkungen von Medizinprodukten mit Blut fest. Dieser Teil enthält: a) eine Klassifizierung von für den Kontakt mit Blut...
This document is referenced by:
DIN EN ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Published by DIN on September 1, 2018
Dieses Dokument legt Anforderungen an Verfahren fest und gibt eine Anleitung, die bei der Beurteilung des Potenzials von Materialien für Medizinprodukte zur Auslösung nachteiliger systemischer...
This document is referenced by:
DIN EN 13060 - Dampf-Klein-Sterilisatoren; Deutsche Fassung EN 13060:2014+A1:2018
Published by DIN on February 1, 2019
Diese Europäische Norm legt die Leistungsanforderungen und Prüfverfahren für Dampf-Klein-Sterilisatoren und deren Sterilisationszyklen fest, die für medizinische Zwecke oder für Materialien verwendet...
This document is referenced by:
DIN EN ISO 7405 - Zahnheilkunde - Beurteilung der Biokompatibilitaet von in der Zahnheilkunde verwendeten Medizinprodukten (ISO 7405:2018, korrigierte Fassung 2018-12); Deutsche Fassung EN ISO 7405:2018
Published by DIN on March 1, 2019
Dieses Dokument legt Prüfverfahren zur Beurteilung der biologischen Wirkungen von in der Zahnheilkunde verwendeten Medizinprodukten fest. Enthalten sind auch Prüfungen von pharmakologischen Stoffen,...
This document is referenced by:
DIN EN ISO 16671 - Ophthalmische Implantate - Spuelloesungen fuer die ophthalmische Chirurgie (ISO 16671:2015 + Amd 1:2017); Deutsche Fassung EN ISO 16671:2015 + A1:2017
Published by DIN on March 1, 2018
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