Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

047

Date of Entry 08/21/2017

FR Recognition Number

6-390

Standard

(Included in ASCA pilot)

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)]

U.S. Identical Adoption

ANSI AAMI IEC 80601-2-35:2009/A1:2016
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

Scope/Abstract

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.

Extent of Recognition

Complete standard

Rationale for Recognition

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

Transition Period

FDA recognition of IEC 80601-2-35 Edition 2.1 2016-04 [Rec# 6-390] will be superseded by recognition of 60601-2-35 Edition 2.0 2020-09 [Rec# 6-483]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-390] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-390] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

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

Relevant FDA Guidance and/or Supportive Publications*

1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series

2. Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: Guidance for Industry and FDA Staff, Issued March 2006.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Crystal Lewis

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6116

Crystal.Lewis@fda.hhs.gov

Carolyn Dorgan

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC

240-402-1656

Carolyn.Dorgan@fda.hhs.gov

Standards Development Organization

IEC

International Electrotechnical Commission