Standardization News

ASTM International’s committee on medical and surgical materials and devices (F04) is developing a proposed standard that will provide a cleaning agent formula to clean dried blood from stainless steel medical devices. 

According to ASTM International member Ralph Basile, the formula described in the new standard will be tested against the relevant tests in D8179, ASTM’s guide on medical device detergents (D8179).

“This will help to provide practical application of D8179, as well as provide a baseline of cleaning agent formulation for this purpose that manufacturers of cleaning agents can compare their formulation to,” said Basile, vice president, Healthmark Industries.  

Basile notes that manufacturers of cleaning agents, independent testing laboratories, other standards organizations, regulators, medical device manufacturers, and healthcare professionals responsible for cleaning clinically-used medical devices will all find the proposed standard (WK70410) useful. 

All interested parties are invited to join in the proposed standard’s ongoing development, which will include an interlaboratory study. Participants include:

• Cleaning agent manufacturers,
• Manufacturers of raw materials used in cleaning agents
• Testing laboratories,
• Medical device manufacturers,
• Cleaning challenge device manufacturers, and
• Regulators.

The committee encourages participation from others representing these stakeholders along with representatives from other stakeholder groups. 

ASTM welcomes participation in the development of its standards. Become a member of ASTM.