IEC 80601-2-35 Edition 2.1 2016-04

Standard Organization:

IEC 80601-2-35 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment-Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]

Recognition Date2017-08-21
Recognition List047
Recognition Number6-390
Extent Complete standard
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG General Plastic Surgery/General Hospital
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§880.5120 Bed, Manual Class 1 FNJ
§880.5110 Bed, Hydraulic, Adjustable Hospital Class 1 FNK
§880.5100 Bed, Ac-Powered Adjustable Hospital Class 2 FNL
§880.5100 Bed, Therapeutic, Ac-Powered, Adjustable Home-Use Class 2 LLI

FDA Guidance:

Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. Issued March 2006

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