The medical bed market is experiencing robust growth, valued at $3.98 billion (USD) in 2024 and projected to reach $6.38 billion (USD) by 2032, reflecting a compound annual growth rate (CAGR) of 6.06%1.
As medical beds are deployed across diverse environments, testing and certification to appropriate safety standards become increasingly critical. UL Solutions offers medical bed testing and certification to safety standards including the new IEC 80601-2-89 to help address evolving industry needs.
Safety challenges for medical beds
Medical beds pose safety challenges in care environments such as hospitals, other medical facilities and private homes. Patient safety is impacted by the individual’s condition, the care setting and the bed’s design.
Key safety considerations
- Unintended movement of mattress support platform – Mechanical, software or electrical failure can create hazards for patients.
- Stability and moveability – The bed’s design must balance stability under varying loading conditions with ease of movement for caregivers. Stability can be compromised by faulty casters, uneven floors or failure to engage wheel locks.
- Patient support – Adjustable height and head/foot sections help position patients for comfort and safety, with movement limited to a defined range.
- Accessories – Components intended to enhance comfort and care may pose hazards if damaged or incompatible.
Major safety risks
Two critical safety risks associated with medical beds are entrapment and patient falls. Entrapment occurs when a patient becomes trapped in areas around the bed, potentially leading to serious injury or death by strangulation or suffocation.
Safety standards for medical beds for children
The new IEC 80601-2-89 will replace the existing safety standard for medical beds:
- IEC 80601-2-89, Medical Electrical Equipment, Part 2-89: Particular Requirements for the Basic Safety and Essential Performance of Medical Beds for Children – This standard is aligned with IEC 60601-1:2010+AMD1:2016+AMD:2020 and covers fully electric, semi-electric and manual beds for children and adults with atypical anatomy. The standard covers cots, cribs, junior beds and oversize cots.
Pathway to compliance with IEC 80601-2-89
UL Solutions works with manufacturers to complete the following steps for compliance with the new medical bed safety standards:
- Determine the applicable standard based on the intended user of the bed. In some instances, both standards may apply.
- Evaluate the bed to the construction requirements and determine the required testing. It is important to determine that the construction complies before testing because any changes made to the bed’s construction may impact test results.
- Review the controls, markings and functionality.
- Conduct the testing required for the applicable standard or standards. Durability testing may require extended time and advanced planning.
- Determine full compliance with the standards.
Why is it important to conduct a preliminary review for products certified to other medical bed for children standards?
A medical bed previously evaluated to other medical bed for children standards requires additional review and may require additional testing to determine compliance with IEC 80601-2-89. A preliminary review of the previously evaluated bed and test data will provide insight into the gaps that need to be addressed.
Why choose UL Solutions?
Working with UL Solutions for medical bed testing and certification offers numerous advantages. Here are some of the top reasons manufacturers of medical beds and other medical devices trust us for their compliance needs.
Benefits of working with a global leader in safety science
- More than 130 years of experience in safety testing
- Decades of specialized expertise in medical device testing
- Testing approaches tailored to meet our customers’ specific needs
- A comprehensive suite of services for medical devices, including testing, certification, validation and market access
Sources
1. Data Bridge Market Research. 2024. Global Medical Bed Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032.
Connect with our team
Contact us today to learn more about our services and discover how we help you evaluate compliance with applicable safety standards and streamline market access for your products.