The Role of Chemical Characterization Testing within a Biological ...

Chemical characterization testing is crucial for the development of new medical devices and assessment of changes to existing medical devices.

Biocompatibility Chemical Characterization - Pacific BioLabs

Chemical Characterization Strategy · Use in an assessment of the overall biological safety of a medical device. · Measurement of the level of any leachable ...

Chemical Characterization of Medical Devices | TUV SUD | TÜV SÜD

Specifically, chemical characterization “can be useful in selecting appropriate biological evaluation tests,” as well as for estimating the anticipated risk ...

Chemical Characterization Testing of Medical Devices - RQM+

This might consist of extractable testing under exaggerated use conditions or leachables testing in the types of environments the device will be ...

Chemical Characterization Supplementing Biocompatibility Tests

The known properties of the compounds can then be used to create a toxicological risk or safety assessment based on the predicted biological ...

A Smart Approach to Chemical Characterization - Eurofins Scientific

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”. 5.

CHEMICAL CHARACTERIZATION ACCORDING TO EN ISO 10993

can also pose safety problems, in particular biological risks in humans during use, if no evaluation is performed. Therefore, the biological evaluation of a ...

The Role of Chemical Characterization in Ensuring Medical Device ...

Chemical characterization is a fundamental step in evaluating the safety and efficacy of medical devices. At the North American Biomedical Institute (NABI), ...

Material and chemical characterization for the biological evaluation ...

This role of chemistry as the central science is very important to medical device evaluations and is noticeably evident in the ISO 10993 approach to the ...

Chemical Characterization & the Non-Targeted Analysis of Medical ...

It is mandatory to assess the MDs for leachable compounds, as these possess a high risk to the patient. Leachable compounds are transferred in the body by the ...

Chemical Characterization in Medical Devices

Chemical characterization tests aim to determine the amount of chemicals extracted from surgical saw blades by measuring them with analytical devices.

Materials and Chemical Characterization and Medical Devices - FDA

The Materials and Chemical Characterization Program develops regulatory science tools for evaluating medical device material biostability ...

ISO-10993-18 Chemical Characterization - NAMSA

Chemical characterization involves the identification of a material and the identification and quantification of its chemical constituents.

Chemical Characterization Can Supplement and Support ...

Chemical characterization can help support the biocompatibility testing process, reduce the use of animal testing, in some cases, shrink turnaround time and ...

New Developments in Medical Device Chemical Characterization

Chemical characterization is required for all new medical devices, but it can also be a useful tool to address some of the changes specified in ISO 10993-1, ...

Chemical Characterization of Medical Devices: An Overview

This testing looks at whether device components, or extracts from a device, have the capacity to cause irritation, damage, or toxicity in an animal system. This ...

ISO 10993-18 Medical Device Chemical Characterization ... - Intertek

Data from the leachables studies can be reviewed in accordance with ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable ...

Do all medical devices require chemical characterization?

The role of chemical characterization in biological evaluation: 1. Provide chemical information for comparing the device under application ...

Chemical Characterization and Non-targeted Analysis of Medical ...

Extractables testing is one approach to chemical characterization that employs combinations of non-targeted analysis, non-targeted screening, and/or targeted ...

An Overview of Chemical Characterization of Medical Devices - RQM+

Chemical characterization plays a crucial role in this process by providing a baseline for comparing devices. ... biological evaluation data and ...