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NEK IEC 60601-1-11:2015

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Status: Check Published
Norwegian title: 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
English title: 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
Item type: Standard
Language: en/fr
Edition: 2.0 (2015-01-20)
Supersedes: NEK IEC 60601-1-11:2010 Alert Withdrawn
NEK IEC 60601-1-11:2010/COR1:2011 Alert Withdrawn
Number of pages: 10
Price:

NOK 4 094,00 (excl. VAT)
NOK 5 117,50 (with VAT)

Scope: IEC 60601-1-11:2015 is available as <a href="https://webstore.iec.ch/publication/22261">IEC 60601-1-11:2015 RLV</a> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.<br /> <br /> IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:<br /> - the dwelling place in which a patient lives;<br /> - 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.<br /> 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:<br /> - correction of test method for relative humidity control at temperatures above 35 °C;<br /> - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and<br /> - harmonizing with the changes to the amendments to the general standard and other collateral standards.
Committee: NEK/NK62A+D
Adopted: 2015-01-20
ICS: 11.040.01 - Medisinsk utstyr generelt
11.020.10 - Helsetjenester generelt
11.040 - Medisinsk utstyr
903.07 - Elektromedisinsk utstyr

Accompanying documents:

NEK IEC 60601-1-11:2015 RLV

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NEK IEC 60601-1-11:2015 RLV