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IEC 60601-1-11:2015

Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Standard Details

- the dwelling place in which a patient lives;
- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- correction of test method for relative humidity control at temperatures above 35 °C;
- redrafting of subclauses that altered instead of adding to the general standard or other collateral StandardDetails; and
- harmonizing with the changes to the amendments to the general standard and other collateral StandardDetails.

General Information

Status : Published
Standard Type: Main
Document No: IEC 60601-1-11:2015
Document Year: 2015
Pages: 109
Edition: 2
  • ICS:
  • 11.040.10 Anaesthetic, respiratory and reanimation equipment

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IEC 60601-1-11:2015
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