Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of emergency and transport ventilators

Designation Number:
CSA C22.2 NO. 80601-2-84
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
ICS code(s):
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an EMS VENTILATOR in combination with its ACCESSORIES, hereafter also referred to as ME EQUIPMENT, intended:

-              for PATIENTS who need differing levels of support from artificial ventilation including for VENTILATOR-DEPENDENT PATIENTS;

-              for use in the EMS ENVIRONMENT; and

-              For invasive or non-invasive ventilation.

 

NOTE 1 An EMS VENTILATOR can also be used for transport within a PROFESSIONAL HEALTHCARE FACILITIES.

 

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM of an EMS VENTILATOR, or to an EMS VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the EMS VENTILATOR.

 

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, 7.2.13 and 8.4.1.

 

NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

 

This part of ISO 80601 does not specify the requirements for

-              VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in critical care applications, which are given in ISO 80601-2-12 [3].

-              VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in the HOME HEALTHCARE ENVIRONMENT, which are given in ISO 80601-2-72 [4].

-              VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in ISO 80601-2-13 [5].

-              VENTILATORS or ACCESSORIES intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing PATIENTS), which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7].

-              Obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 219 80601-2-70 [8].

-              OPERATOR-powered resuscitators, which are given in ISO 10651-4 [9].

-              Gas-powered emergency resuscitators, which are given in ISO 10651-5 [10].

-              Continuous positive AIRWAY PRESSURE (CPAP) ME EQUIPMENT.

-              High-frequency jet VENTILATORS (HFJVs).

-              High-frequency oscillatory VENTILATORS (HFOVs) [11].

-              Cuirass or “iron-lung” VENTILATORS.

 

This part of ISO 80601 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of documents.

 

Project need:

To maintain alignment with international requirements on the particular requirements for the basic safety and essential performance of emergency and transport ventilators

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.