Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices

(In-person only event)

Date: May 9, 2023

Event Location:  Sheraton Denver Downtown Hotel, Denver, Colorado

Organized by: ASTM Committee F04 Medical and Surgical Materials and Devices


About the Event

Abstracts for presentation at the Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices to be held on May 9, 2023. The workshop is organized by ASTM Committee F04 Medical and Surgical Materials and Devices, and will be held at the Sheraton Denver Downtown Hotel, Denver, Colorado in conjunction with the May standards development meetings of the committee.  The language of the workshop will be English.


Objective and Scope

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
    • Include manufacturing residues, particles, environmental agents, cleaning agents
    • Exogenous factors
    • Knowing what your manufacturing materials are composed of
  • Methods for establishing acceptance limits
    • Historical clinical history
    • Toxicological risk assessment
    • Cytotoxicity
    • Patient risk assessment
  • Approaches for using acceptance limits in cleaning validation
    • How cleaning affects sterilization
    • How cleaning affects biocompatibility
    • Consistency of cleaning process
    • Impact of cleaning on device functionality or user experience
    • Risk assessment in using acceptance limits
  • When to modify acceptance limits
  • Approaches to limit establishment when there is a change in manufacturing process
  • What are the gaps in acceptance limits guidance?
  • The pharmaceutical manufacturer position on acceptance limits
  • Regulatory perspective on setting limits and rationale
  • Development of proposal(s) for development of new ASTM standards related to acceptance limits for medical devices


Abstract Submission

Please submit your 300-word abstract pertaining to the above topics to Workshop Co-Chairs Stephen Spiegelberg at and Ralph Basile at by close of business February 28, 2023.


Publication Information

Symposium authors are required to submit their papers for ASTM publication in Selected Technical Papers (STP), an online and printed, peer-reviewed publication for the international scientific and engineering community. STP papers should be full-length technical papers of approximately 10,000 words, significantly contribute to the technical literature, and must include a review of past work in the relevant area and present information of current interest or probe new fields. After the final selection of abstracts has been approved, the ASTM Editorial Office will send authors’ instructions via email, but also can be found by clicking here.

Manuscripts to be peer reviewed for the STP are due online no later than DATE at the ASTM Editorial Office. The corresponding author (the author who is the main contact with ASTM Headquarters) will receive a copy of his/her paper in portable document format (PDF). All published authors will have the opportunity to purchase reprints of their papers at a nominal cost. Only those papers submitted by the manuscript due date will be included in the STP. Please note that all submitted papers are subject to peer review by two independent reviewers.

The STP will be submitted to the Library of Congress with an ISBN number and will be reviewed for inclusion in the Web of Science Conference Proceedings Citation Index (CPCI) and Google Scholar.


Technical Program


Registration opens approximately 10 weeks before the start of the start of the workshop.



Registration is now open. The fees to attend this event are listed below.

This is an in-person only event.



April 7, 2023

After April 7, 2023
ASTM Member $215.00 $265.00
Non-member $265.00 $315.00
Presenter Waived Waived
Student Waived Waived

Not an ASTM Member?  An individual membership costs only $75.00 a year. If you would like to become a member of ASTM International and Committee F04 to begin taking advantage of all the ASTM membership benefits, including attending this event for free, please use the link below to join ASTM before registering for the event.


All Attendees – All attendees are urged to register for this workshop before arriving onsite. All attendees must check in at the ASTM Registration Area to obtain their name badge before entering the event room.

Presenters -- Presenters' fees are waived; ASTM will register workshop presenters on their behalf.

Students – Students may be eligible for a reduced registration fee provided they meet certain requirements. To qualify for the reduced fee you must be a full-time student, not employed full-time, and be able to provide a current valid university email address for registration. To register as a student, please email ASTM Symposia Operations at

Cancellations – A refund of the workshop fee will be honored only if requested at least 10 business days prior to the start of the event. To cancel your registration and request a refund, please contact Symposia Operations at or 610-832-9522.

If you have questions concerning online registration, please contact Symposia Operations at Tel: 610-832-9522, or ASTM Technical Support at or 1-877-909-2786 (domestic) or 610-832-9578 (international).


Technical Chair Contact Information

Stephen Spiegelberg
Cambridge Polymer Group

Ralph Basile
Healthmark Industries Co


Continuing Education Units

Workshop attendees interested in receiving 0.7 Continuing Education Units (CEUs) must complete the CEU application form in the back of the program booklet and email it to ASTM Symposia Operations at You must be registered and have attended the entire event in order to receive the CEU’s. A certificate will be sent to you via email approximately 1 to 2 weeks after the workshop concludes.


Hotel Information

All meetings will be held at The Sheraton Denver Downtown Hotel, 1550 Court Pl. Denver, CO, 80202.
Hotel Reservations:
Please support ASTM International by reserving your sleeping room at our official May Committee Week Hotel and Meeting site.

To book accommodations under the ASTM Rate, please click here: Sheraton Denver Downtown Hotel Reservations.

The discounted rate will be honored until the ASTM block is full, but no later than April 7th, 2023. The ASTM rate is $209 plus tax. You may be charged a higher rate if reservations are received after the cut-off date, or when the block is full. The hotel requires a credit card to guarantee your reservation, once submitted a confirmation number will be provided electronically. To book accommodations using the ASTM rate, please click the link below.

CANCELLATION/CHANGE POLICY: At the Sheraton Denver Downtown Hotel, notice of cancelation must be received 3 days prior to day of arrival in order to avoid a charge. Failure to do so will incur a penalty equal to the cost of one night's room and tax.

Sheraton Denver Downtown Hotel Government Reservations The Sheraton Denver Downtown Hotel has a limited number of rooms at the government per diem rate. Reservations may be made via our online reservation system using the blue hyperlink above. You must present your ID at the front desk upon check-in.
IMPORTANT! ASTM Rates are non-commissionable. If you book your reservation through a travel agent, they must ask for a non- commissioned ASTM Group Rate. ASTM cannot adjust your higher rate if commissions were paid to a travel agency.

The May Committee Week Hotel provides prime meeting space for your committee meetings, events and activities. ASTM International is legally bound to fill the contracted guest room block and an inability to fill the block will result in severe financial penalties which could affect negotiations and increase costs for future meetings.

INTERNET: The Sheraton Denver Downtown Hotel offers free wireless to Bonvoy Members.


Standards Development Meetings

Committee F04 invites you to attend their future standards development meetings. There is no fee to attend these meetings, and membership in ASTM International is not required to attend. For more information about the committee and it's future meetings, please visit the F04 homepage on the ASTM website.