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CSA Group , 05/01/2021
Publisher: CSA
File Format: PDF
$132.00$264.00
CSA C22.2 NO. 80601-2-85:21 PDF
Preface:
This is the first edition of CSA C22.2 No. 80601-2-79, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-79 (first edition, 2018-07). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC Standard 60601-1:2005, including Amendment 1:2012, with Canadian deviations).
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope:
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:
EXAMPLE 1 PATIENTS with mild to moderate chronic obstructive pulmonary disease (COPD).
NOTE 1 In the HOME HEALTHCARE ENVIRONMENT, the SUPPLY MAINS is often not reliable.
NOTE 2 Such VENTILATORY SUPPORT EQUIPMENT can also be used in non-critical care applications of professional health care facilities.
This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to the BREATHING SYSTEM of VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, DISTRIBUTED ALARM SYSTEM.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601-1:2005 +AMD1:2012, 4.2.
This document does not specify the requirements for:
Object:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the VENTILATORY SUPPORT EQUIPMENT and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT.
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