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DS/EN ISO 80601-2-80 - Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)
September 23, 2019 - DS

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in the home...

DS/EN ISO 80601-2-79 - Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
September 23, 2019 - DS

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in the home...

DS/ISO 80601-2-80 - Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
July 23, 2018 - DS

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in the home...

DS/ISO 80601-2-79 - Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
July 23, 2018 - DS

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in the home...

ISO 80601-2-80 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
July 1, 2018 - ISO

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: - intended for use in the HOME...

ISO 80601-2-79 - Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
July 1, 2018 - ISO

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: - intended for use in the HOME...

CSA C22.2 NO 80601-2-72 - Medical electrical equipment - Part 2‐72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilatordependent patients
January 1, 2017 - CSA

This part of ISO 80601 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 the HOME HEALTHCARE ENVIRONMENT; - intended for use by a LAY OPERATOR; - intended for use with...

DIN EN ISO 80601-2-72 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
April 1, 2016 - DIN

IEC 60601‐1:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 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 the HOME HEALTHCARE ENVIRONMENT; - intended for use...

DS/EN ISO 80601-2-72 - Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
November 5, 2015 - DS

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in 270 combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: 271 - intended for use in the HOME HEALTHCARE ENVIRONMENT; 272 - intended for use by a LAY OPERATOR; 273 - intended...

ISO 80601-2-72 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
September 1, 2015 - ISO

IEC 60601‐1:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 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 the HOME HEALTHCARE ENVIRONMENT; - intended for use...

ASTM F1246-91(2005) - Standard Specification for Electrically Powered Home Care Ventilators, Part 1-Positive-Pressure Ventilators and Ventilator Circuits (Withdrawn 2014)
December 1, 2005 - ASTM International

This specification covers all electrically powered lung ventilators and ventilator circuits specifically intended for use in the home environment, breathing circuits intended specifically for use with home care ventilators are also included. The test methods for power source...

ASTM F1101-90(2003)e1 - Standard Specification for Ventilators Intended for Use During Anesthesia (Withdrawn 2012)
December 1, 2003 - ASTM International

1.1 This specification applies to all ventilators specifically introduced for sale following acceptance of this specification and intended for use during the administration of anesthesia. Definitions, performance requirements, test methods, and a rationale for all mandatory requirements are...

CSA ISO 7767 - Oxygen monitors for monitoring patient breathing mixtures - Safety requirements
March 1, 1998 - CSA

IS0 7767 is one of a series of International Standards based on IEC 601-1 (the "General Standard"). This type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC...

DSF/EN ISO 80601-2-13/FPR - Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation – Amendment 2 (ISO 80601-2-13:2011/FDAM 2:2017)
DS

ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic...

DSF/PREN ISO 80601-2-90 - Medical electrical equipment – Part 2-90: Particular requirements for basic safety and essential performance of ventilatory high-flow therapy equipment (ISO/DIS 80601-2-90:2020)
DS

This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use in...

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