| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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6-512
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| Standard | (Included in ASCA) |
IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
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Scope/AbstractThis part of 60601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2;
- INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];
- cooling devices. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of IEC 60601-2-35 Edition 2.0 2020-09 [Rec# 6-483] will be superseded by recognition of IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION [Rec# 6-512]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-483] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 6-483] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §880.5100 |
Bed, Ac-Powered Adjustable Hospital
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Class 2
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FNL
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| §880.5100 |
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
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Class 2
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LLI
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| §880.5110 |
Bed, Hydraulic, Adjustable Hospital
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Class 1
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FNK
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| §880.5120 |
Bed, Manual
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Class 1
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FNJ
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
