EN 80601-2-35

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Logo of the German Institute for Standardization DIN EN 80601-2-35
Area Medical technology
title Medical electrical equipment - Part 2-35: Particular requirements for the safety including the essential performance characteristics of blankets, mats and mattresses for heating patients in medical applications
Latest edition 8.2010
ISO IEC 80601-2-35: 2009

The EN 80601-2-35 with the title "Part 2-35: Special stipulations for the safety including the essential performance features of blankets, mats and mattresses for warming patients in medical applications" is part of the EN 60601 series of standards .

The German Institute for Standardization is the publisher of the DIN standard DIN 80601-2-35 .

The standard is based on the international version IEC 80601-2-35. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-35 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines for mats, pads and mattresses for heating patients in medical applications. The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.

validity

The German edition 8.2010 is accepted as a German standard from the date of its publication .

scope of application

These Special Provisions specify requirements and tests for the safety of ceilings, sheets and mattresses, including mattresses with airflow and air-assisted systems, as defined in Sections 2.2.102, 2.2.106 and 2.2.107. Warming facilities are intended for medical and paramedical use.

Changes

Compared to the previous standard EN 60601-2-35: 1997-12, the following changes have been made:

  • Adaptation to the structure and philosophy of the EN 60601-1 : 2007 (3 rd Edition)
  • Definition of the essential performance characteristics in section 201.4.3
  • Adaptation of the EMC conditions to EN 60601-1-2 : 2007
  • Adaptation of the requirements for alarms according to EN 60601-1-8 : 2008
  • Adaptation of the requirements for physiological closed control loops according to EN 60601-1-10 : 2008

In detail, the changes relate in particular to the following topics (excerpt):

  • separation
  • Leakage currents
  • Protection against mechanical hazards
  • Protection against excessive temperatures / dangerous initial values
  • Error cases
  • construction