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

M305.2 Transfer Supports

M305.2.2 Transfer Supports Structural Strength

Proposed requirement:

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.

• Sub-Committee Recommendation:
Transfer supports and their connections shall be capable of resisting vertical and horizontal forces of 250 pounds (1,112 N) applied at the worst case accessible location without creating an unacceptable risk.

Rationale: Manufacturer shall determine the worst case accessible location(s) and test at these locations.

Acceptance criteria must be defined. It is understood that the Transfer Support will deform to some degree under these loads. This clause should limit elastic deformation and prohibit permanent deformation or breakage.

Possible language as modified from IEC 60601-2-52: “Transfer Supports shall be designed to withstand the forces applied during reasonably foreseeable use without creating an unacceptable RISK.”

As manufactures of medical equipment, ISO 14971 “Application of risk management to medical devices” is a commonly adhered to standard. As a result, product development normally includes the application of risk management practices and will consequently define “unacceptable risk” as it applies here.