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On-demand webinar –
Biocompatibility analysis of respiratory medical devices according to ISO 18562
Regulations on the biocompatibility evaluation of medical devices (ISO 10993-1:2018) highlight the need for manufacturers to measure chemicals released from their respiratory devices’ components into the breathing gas pathways of patients.
ISO 18562 (recognised by the Food and Drug Administration) stipulates how these measurements should be carried out, including tests for extractables and leachables, particulate matter and volatile organic compounds (VOC).
This webinar will focus on best practice in sampling and analysis of VOCs from respiratory medical devices.
What you will learn:
Requirements for ISO 18562.
How to sample VOCs from respiratory medical devices.
Analytical methodology required for ISO 18562.
How to reach lower detection limits for volatile extractables and leachables.
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Markes International Ltd
Gwaun Elai Medi-Science Campus
Llantrisant | CF72 8XL
UK
Tel: +44 (0)1443 230935
Fax: +44 (0)1443 231531
Email: enquiries@markes.com
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Markes International GmbH
Bieberer Strasse 1
63065 Offenbach am Main
Germany
Tel: +49 (0)69 6681089-10
Fax: +49 (0)69 6681089-11
Email: enquiries@markes.com
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Markes International, Inc.
2355 Gold Meadow Way | Gold River, Sacramento
California 95670
USA
Tel: 866-483-5684 (toll-free)
Fax: 513-745-0741
Email: enquiries@markes.com
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Markes Instruments (Shanghai) Co., Ltd
No. 1 Building, No. 7 Guiqing Road
Xuhui District
Shanghai 200233
P.R. China
Tel: +86 21 5465 1216
Email: enquiries@markes.com
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