UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

DIN EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017

active, Most Current
Buy Now
Organization: DIN
Publication Date: 1 February 2018
Status: active
Page Count: 26
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

Dieses Dokument stellt Grundlagen für Konzeption und Durchführung von toxikokinetischen Untersuchungen, die bei Medizinprodukten von Bedeutung sind, zur Verfügung. Anhang A beschreibt die Überlegungen zur Durchführung toxikokinetischer Untersuchungen zur biologischen Beurteilung von Medizinprodukten.

Document History

DIN EN ISO 10993-16
February 1, 2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
Dieses Dokument stellt Grundlagen für Konzeption und Durchführung von toxikokinetischen Untersuchungen, die bei Medizinprodukten von Bedeutung sind, zur Verfügung. Anhang A beschreibt die...
DIN EN ISO 10993-16
April 1, 2016
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016
A description is not available for this item.
DIN EN ISO 10993-16
June 1, 2010
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010
A description is not available for this item.
DIN EN ISO 10993-16
August 1, 2009
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:2009
A description is not available for this item.
DIN EN ISO 10993-16/A1
February 1, 2009
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); English version prEN ISO 10993-16:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 10993-16
August 1, 2008
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2008); German version prEN ISO 10993-16:2008
A description is not available for this item.
DIN EN ISO 10993-16
November 1, 1997
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:1997
A description is not available for this item.
View Less
View All

References

This document references:
DIN EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
Published by DIN on April 1, 2010
A description is not available for this item.
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 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
10993-17 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
Published by ISO on September 1, 2023
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is...
This document references:
ISO 10993-18 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Published by ISO on January 1, 2020
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...
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 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO TR 10993-22 - Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
Published by ISO on July 1, 2017
This document describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation...
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,...
View Less
View All
Advertisement