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NEN-EN-ISO 80601-2-12

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

active
Organization: NEN
Publication Date: 1 May 2011
Status: active
Page Count: 98
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: - intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.

Document History

October 1, 2011
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
A description is not available for this item.
NEN-EN-ISO 80601-2-12
May 1, 2011
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of...
August 1, 2009
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of...

References

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