Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

BACKGROUND

Section 5.4.11 of the Committee report makes the following recommendation:

5.4.11 Transfer Support Structural Strength Recommendations for M301 and M302

Description: Transfer supports and their connections must be capable of resisting sufficient vertical and horizontal forces to remain stable during use. The proposed provision addresses these aspects of structural strength.

NPRM Proposed Provision: M305.2.2 Structural Strength. Transfer supports and their connections shall be capable of resisting vertical and horizontal forces of 250 pounds (1,112 N) applied at all points on the transfer support.

The Committee recommends transfer supports and connections contain the strength to resist vertical and horizontal forces of 250 pounds at locations determined by the intended use of the equipment.

Rationale for the recommendation

The Committee recommends a proposal that harmonizes the transfer support requirements with other provisions for transfer supports. The proposed technical criteria originated from provisions for grab bars in the 2010 Standards. During discussion manufacturers stated that industry is required to test the most vulnerable spots on the transfer support. Industry must follow testing parameters found in other standards. IEC60601-2-52: “Transfer Supports shall be designed to withstand the forces applied during reasonably foreseeable use without creating an unacceptable RISK.” Transfer supports will deform to some degree under these loads, it must remain stable enough for use. This clause should limit elastic deformation and prohibit permanent deformation or breakage. Manufacturers of medical equipment must follow ISO14971 “Application of risk management to medical devices”, a commonly followed standard. Product development manufacturers must use risk management practices to avoid any unacceptable risk defined by the specific product designs.