IEC 60601-2-35:2020/AMD1:2023 CSV
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

Standard No.
IEC 60601-2-35:2020/AMD1:2023 CSV
Release Date
2023
Published By
International Electrotechnical Commission (IEC)
Status
Replace By
IEC 60601-2-35:2023
Latest
IEC 60601-2-35:2023
 

Introduction
This standard establishes specific safety and performance requirements for heating devices used in medical settings, particularly those that employ blankets, pads, or mattresses to provide thermal therapy. It focuses on ensuring the fundamental safety and essential performance of such equipment, addressing potential risks associated with their operation. The document outlines testing procedures, design considerations, and operational guidelines to meet the necessary safety standards. It also includes amendments and updates to the original standard, reflecting the latest advancements and regulatory requirements. The content is structured to support manufacturers, regulatory bodies, and healthcare professionals in the proper implementation and compliance with these safety measures.

IEC 60601-2-35:2020/AMD1:2023 CSV history

  • 2023 IEC 60601-2-35:2023 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
  • 0000 IEC 60601-2-35:2020/AMD1:2023 CSV
  • 2020 IEC 60601-2-35:2020 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • 1996 IEC 60601-2-35:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

Standard and Specification

IEC 60601-2-35:2020+AMD1:2023 CSV 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 DS/EN 80601-2-35/A11:2011 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 DS/EN 80601-2-35:2010 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 EN 80601-2-35:2009 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 KS C IEC 60601-2-35:2011 Medical electrical equipmentPart 2-35Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended CAN/CSA-C22.2 NO.80601-2-35-2012(R2021 Medical electrical equipmentPart 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended AAMI/ISO 80601-2-35:2009 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 GOST IEC 60601-2-35-2022 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 GSO IEC 80601-2-35:2013 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 IEC 80601-2-35:2009 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



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