Purity of medical devices in the manufacturing process

The new guideline VDI 2083 Sheet 21 »Cleanliness of Medical Devices in the Manufacturing Process« describes a universally applicable approach to deriving acceptance criteria and provides guidance for selecting an appropriate testing method.

Based on the VDI guideline, the industry consortium aims to further specify the support for deriving acceptance criteria in the following areas:

- Research of product-specific regulations with cleanliness requirements for medical devices
- Examples for deriving/adapting from non-product-specific regulations
- Approaches to clustering medical devices from a cleanliness perspective
- Current state analysis: determining values for particulate contamination

Kick-Off Meeting Industry Consortium

Date and Location
November 26, 2019
Fraunhofer IPA, Nobelstr. 12, 70569 Stuttgart

Participation Fee
Free of charge
Open kick-off meeting, non-binding participation possible to get information about the orientation of the industry consortium.

Target Audience
Manufacturers and suppliers of medical devices are invited

More Information
https://www.ipa.fraunhofer.de/en/events/exhibitions/cleanliness_of_medical_devices.html

Contact

Technical Contact Person
Dipl.-Ing. Guido Kreck
Phone: +49 711 970-1541
guido.kreck@ipa.fraunhofer.de

Online Registration
https://www.ipa.fraunhofer.de/en/events/registration-cleanliness_of_medical_devices.html