What is 60601-2-52?
60601-2-52 (including BS EN 60601-2-52, EN 60601-2-52 and IEC 60601-2-52) is the particular standard for medical beds, that addresses specific hazards for manufacturers to ensure their devices meet the basic safety and essential performance requirements needed.
A medical bed, as defined within the standard (201.3.212), is a “device for which the intended use is sleeping/resting that contains a mattress support platform and intended to assist in diagnosis, monitoring, prevention, treatment, alleviation of disease or compensation for an injury or handicap”.
Excluded under this definition are “devices for which the intended use is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table)”.
Are there clear industry definitions of a medical bed and a patient stretcher?
GMDN (Global Medical Device Nomenclature) are the leading global standard for the naming, classification and categorisation of medical devices, which provides healthcare professionals, regulators, manufacturers and others with a common language for and definition of medical devices.
Manual hospital bed
A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.
Basic electric hospital bed
A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.
Hospital stretcher, manual
A manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters).
Hospital stretcher, powered
A battery-powered mobile platform designed to transport a recumbent patient within a healthcare facility (e.g., to and from beds, chairs, treatment facilities, wheelchairs, and transportation vehicles). It typically includes a fixed, wheeled undercarriage, batteries, electric motor(s), and steering/operative controls. Some types, when fitted with a radiolucent surface, may be used for the acquisition of radiographic images.
What is the relevance of 60601-2-52 to the Anetic Aid patient stretchers?
The current British Standard for patient trolleys (or patient transport stretchers) applicable in the UK remains as BS 5402:1976 Specification for Patient trolleys.
But due to the lack of a recognised international standard specific to patient trolleys, in combination with the additional level of detailed focus on more specific hazards and essential performance, the industry now more commonly applies the requirements of 60601-2-52 to their patient stretcher designs.
Are Anetic Aid patient stretchers compliant with 60601-2-52?
In short, yes.
The QA3™ Patient Stretcher system is designed and manufactured in compliance with (but not limited to):
· BS 5402 - Patient Trolleys
· BS EN 60601-2-52 - Medical Electrical Equipment. Particular requirements for basic safety and essential performance of medical beds
The QA4™ Mobile Surgery System is designed and manufactured in compliance with (but not limited to):
· BS 6859-1 - Operating tables. Specification for mobile generating operating tables
· BS EN 60601-2-46 - Medical Electrical Equipment - Particular requirements for the basic safety and essential performance of operating tables
· BS EN 60601-2-52 - Medical Electrical Equipment. Particular requirements for basic safety and essential performance of medical beds
A combination of the three as there is no specific standard dedicated to a mobile surgery stretcher.
Summary
Our QA3™ Patient Stretcher system has been on the market since 1997 and the QA4™ Mobile Surgery System since 2004.
As an international supplier of medical devices and an ISO 13485 certified company, the Anetic Aid patient stretcher range and mobile surgery system are compliant with 60601-2-52.
You can download our full flyer here: Anetic Aid 60601-2-52 & Patient Stretchers Flyer
Alternatively, you can contact our team for more information by clicking on the 'Contact The Team' link here: Contact The Team