NEN-EN-ISO 80601-2-12
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
inactive
| Organization: | NEN |
| Publication Date: | 1 May 2011 |
| Status: | inactive |
| 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
November 1, 2023
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of a critical care ventilator in combination...
March 1, 2020
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
intended for use in an environment...
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...