There is an IEC standard IEC 60601-2-52 for hospital beds that is a part of the IEC 60601 family. The base standard IEC 60601-1 would be applicable as well as several of the collateral standards such as the one for homecare IEC 60601-1-11, IEC 60601-8 covers alarms, IEC 60601-1-6 covers usability, IEC 60601-1-2, covers electromagnetic disturbances There may be other standards that apply such as IEC 62304 for software if that is part of the product.
The hospital bed standard is being revised and will appear as IEC 80601-2-52 to cover both electrical and mechanical beds, and a children's bed standard for both mechanical and electrical beds will also appear as IEC 60601-2-89. These documents are still under development and will not appear in 2021.
I am a member of the US national committee providing input to this project.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 08-Jan-2021 14:54
From: Patty Beja
Subject: Electric Homecare and Hospital Bed Standards for US, Canada
Happy Friday.
We are looking to gather current standards and regulations for electric homecare and hospital beds. We are aware of the FDA required standards linked to the product codes as well as US and Canadian entrapment guidelines. Are there any other standards or best practices that we should be aware of and implement?
Thanks for your thoughts.
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Patty Beja
Manager, Regulatory Affairs
Oceanside NY
United States[
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