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DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

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Organization: DIN
Publication Date: 1 September 2017
Status: active
Page Count: 43
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

DIN EN ISO 10993-6
September 1, 2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
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)
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)
A description is not available for this item.

References

This document references:
ISO 5832-2 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
Published by ISO on March 1, 2018
This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile...
This document references:
ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Published by ISO on October 1, 2018
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the...
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 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 is referenced by:
DIN EN ISO 15621 - Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)
Published by DIN on September 1, 2017
This document gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published...
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)
Published by DIN on December 1, 2017
This document 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...
This document is referenced by:
DIN EN ISO 15798 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
Published by DIN on February 1, 2018
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during...
This document is referenced by:
DIN EN ISO 16671 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017) (includes Amendment :2017)
Published by DIN on March 1, 2018
This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product...
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)
Published by DIN on September 1, 2018
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
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