A brief analysis of the design and manufacturing standards for medical trolleys – Interpretation of the mechanical safety part of IEC60601

A brief analysis of the design and manufacturing standards of medical trolleys – Interpretation of the mechanical safety part of IEC60601 Date: 2018-10-15 Foreword In China, the country’s 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 registration certificate or filing that does not exist; or they think…

Background

CORITON: A brief analysis of the design and manufacturing standards of medical carts – Interpretation of the mechanical safety part of IEC60601 Date: 2018-10-15 Foreword In China, the country’s 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…

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.

Key information

• CORITON: A brief analysis of the design and manufacturing standards of medical carts – Interpretation of the mechanical safety part of IEC60601 Date: 2018-10-15 Foreword In China, the country’s 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…
• 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.

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-5737