Standardization News

ASTM International’s committee on medical and surgical materials and devices (F04) has approved the third in a series of standards that help evaluate effective cleaning procedures for medical devices. The new guide, which focuses on extraction of test soils to validate cleaning methods, will soon be published as F3321.

According to ASTM International member Ralph Basile, the guide is an important step in the process of validating cleaning instructions that healthcare workers perform to prepare a device for the next patient. 

Device manufacturers, testing laboratories, and regulatory agencies will be the primary users of the new standards. Basile notes that healthcare facilities might also find the new standard helpful in understanding how manufacturers validate their cleaning instructions.

Basile notes that the committee is now developing a fourth standard in this series, aimed at detecting and quantifying cleaning markers for validating cleaning methods for reusable medical devices (WK63284). The previous two standards are F3208 and F3293.

For more news in this sector visit ASTM Standards for Healthcare Services, Products and Technology.

ASTM welcomes participation in the development of its standards. Become a member of ASTM. The next meeting of ASTM International medical and surgical materials and devices committee is Nov. 5-8, in Houston, Texas, USA.

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