Feb 13, 2023

Registration is open for ASTM International’s Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices, to be held May 9, 2023 at the Sheraton Denver Downtown Hotel (Denver, Colorado, USA). The event is sponsored by ASTM’s medical and surgical materials and devices committee (F04) and will be held in conjunction with the May standards development meetings of the committee.

This workshop will identify current best practices in setting acceptance limits in cleaning of medical devices, gaps in standardization of this practice, and areas where new standards would be useful. Considerations include crossover with ISO 10993 standards and potential updates to these requirements.

Topics include, but are not limited to:

• Case studies of cleaning with issues associated with acceptance limits;
• Current standards on cleaning of medical devices;
• Types of residues and considerations;
• Methods for establishing acceptance limits;
• Approaches for using acceptance limits in cleaning validation;
• When to modify acceptance limits;
• Approaches to limit establishment when there is a change in manufacturing process;
• Gaps in acceptance limits guidance;
• Pharmaceutical manufacturer position on acceptance limits;
• Regulatory perspective on setting limits and rationale; and
• Development of proposal(s) for development of new ASTM standards related to acceptance limits for medical devices.

Additional information is available from the workshop’s technical chairs, Stephen Spiegelberg () and Ralph Basile ().

To register for the event or for more information, visit .

Symposia Operations Contact: Tammy Schane, tel+1.610.832.9522,

Release #11618

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