IEC60601 – Interpretation of Mechanical Stability Testing Clauses for Medical Equipment

Medical Cart Mechanical Safety Testing Methods and Requirements One Introduction In China, the national definition of medical devices refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are used directly or indirectly on the human body, including the required computer software. Because medical carts do not directly act on the human body, the Food and Drug Administration clearly stipulates that medical equipment carts are not medical devices, causing many people to be unclear about the standards and requirements for medical carts. Either they mistakenly believe that the medical cart is a medical device and ask the manufacturer for a non-existent registration certificate or filing; or they think that the medical cart is not a medical device and does not have any standards. In fact, in Europe…

Background

CORITON: – One of the mechanical safety testing methods and requirements for medical carts. Introduction In China, the national definition of medical devices refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibration materials, materials and other similar or related items that are used directly or indirectly on the human body, including the required computer software. Because medical carts do not directly act on the human body, the Food and Drug Administration clearly stipulates that medical equipment carts are not medical devices, which has resulted in…

One of the mechanical safety testing methods and requirements for medical carts Introduction In China, the national definition of medical devices refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibration materials, materials and other similar or related items that are used directly or indirectly on the human body, including the required computer software.

Because medical carts do not directly act on the human body, the Food and Drug Administration clearly stipulates that medical equipment carts are not medical devices, causing many people to be unclear about the standards and requirements for medical carts.

Key information

• CORITON: – One of the mechanical safety testing methods and requirements for medical carts. Introduction In China, the national definition of medical devices refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibration materials, materials and other similar or related items that are used directly or indirectly on the human body, including the required computer software. Because medical carts do not directly act on the human body, the Food and Drug Administration clearly stipulates that medical equipment carts are not medical devices, which has resulted in…
• One of the mechanical safety testing methods and requirements for medical carts Introduction In China, the national definition of medical devices refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibration materials, materials and other similar or related items that are used directly or indirectly on the human body, including the required computer software.
• Because medical carts do not directly act on the human body, the Food and Drug Administration clearly stipulates that medical equipment carts are not medical devices, causing many people to be unclear about the standards and requirements for medical carts.

What this means for medical device customers

It reflects CORITON's ongoing work in medical trolley design, quality management, compliance documentation, global service and practical customer support.

FAQ

Who should read this update?

Medical device manufacturers, distributors, OEM project teams, hospital procurement teams and partners evaluating medical carts, mounting systems or regulatory support from CORITON.

Why is this relevant to CORITON customers?

It reflects CORITON's ongoing work in medical trolley design, quality management, compliance documentation, global service and practical customer support.

News Code: KRT-N-5652