Product category:
QC and QA systems
News Release from: Smithers Rapra | Subject: Chemical Characterisation
Edited by the Processingtalk Editorial
Team on 12 February 2004
Courses for the medical supply
industries
Rapra Technology custom-made courses for the medical supply industries to help industry professionals address the technical and materials consequences of new and forthcoming product legislation
Rapra Technology, Europe's leading independent polymer specialist, is holding a number of custom-made training courses for the medical supply industries in order to help industry professionals there address the technical and materials consequences of new and forthcoming product legislation The first course this year will be held at Rapra Technology, Shawbury, Shropshire on Thursday March 25th, and will be about Materials Characterisation and ISO 10993 Pt 18
This article was originally published on Processingtalk on 28 Jun 2004 at 8.00am (UK)
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The release of the ISO 10993 standard; Biological Evaluation of Medical Devices, Part 18: Chemical Characterisation of materials has radically changed the approach adopted by many manufacturers to demonstrate the biological safety of their devices for the purposes of device registration.
Part 18, for example, will instigate a move away from animal testing and towards more chemical-based assessments of the make-up and quantity of all the chemical components in contact with the body.
ISO 10993 Pt 18 provides an outline of the information that will be necessary to enable a full biological risk assessment to be conducted.
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With the new standard the chemical characterisation information generated will be used.
To assess the biological safety of the device.
To demonstrate equivalence with a clinically established device.
To screen potential new materials for specific applications.
To establish "scale-up" and "development" uniformity.
The step-wise approach suggested by the new standard also provides guidance as to the various analytical techniques that may be employed and to the data that can be gained from their use.
The Rapra Technology new training course on ISO 10993 Pt 18 on March 25 will provide.
A guide to the methodology for the chemical characterisation of the commonly used materials.
An overview of the analytical techniques used and their strengths and limitations.
An introduction to the practicalities of sample preparation and solvent extraction.
An introduction to the toxicological interpretation of the data generated.
Case studies detailing the characterisation of different materials.
An opportunity for Q and A with some of Rapra's senior analytical staff.
David Ingles, Head of Rapra Technology Sales and Head of the Rapra Medical and Healthcare activity says that 'we at Rapra are delighted to be using our independent status in the service of the healthcare sector by providing this 'cutting edge' training day.
We know that the new standard has caused producers much concern.
We are therefore aiming to provide delegate companies with all that they need in relation to the issues arising'.
The ISO 10993 Pt 18 course is at Rapra Technology, Shawbury, on Thursday March 25.
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