CAN/CSA-C22.2 NO. 80601-2-72:17

Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
        and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
        HAZARDS
201.11 Protection against excessive temperatures and other
        HAZARDS
201.12 Accuracy of controls and instruments and protection
        against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
        ME SYSTEMS
201.101 Gas connections
201.102 Requirements for the VBS and ACCESSORIES
201.103 Spontaneous breathing during loss of power supply
201.104 Training
201.105 Indication of duration of operation
201.106 FUNCTIONAL CONNECTION
201.107 Display loops
201.108 POWER SUPPLY CORDS
201.109 VENTILATOR security
202 Electromagnetic disturbances - Requirements and tests
206 Usability
208 General requirements, tests and guidance for alarm
    systems in medical electrical equipment and medical
    electrical systems
211 Requirements for medical electrical equipment and
    medical electrical systems used in the home
    healthcare environment
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Data interface requirements
Annex CC (informative) - Reference to the Essential
         Principles
Annex DD (informative) - Alphabetized index of defined
         terms used in this particular standard
Bibliography

Pertains 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; and - intended for use with PATIENTS who are dependent on mechanical ventilation for their life support.

Preface This is the first edition of CAN/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 ventilator-dependent patients, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-72 (first edition, 2015-09-01). It replaces CAN/CSA-Z10651-2:06, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator dependent patients (adopted ISO 10651-2:2004). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as \"CAN/CSA-C22.2 No. 80601-2-72\" throughout. 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 60601-1:2005, including Amendment 1:2012, with Canadian deviations) and CAN/CSA-C22.2 No. 60601-1-11:15, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (adopted IEC 60601-1-11:2015, with Canadian deviations). Scope and Object IEC 60601-1:2005+AMD1:2012, Clause 1 applies, except as follows: 201.1.1 *Scope 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 by a LAY OPERATOR; intended for use with PATIENTS who are dependent on mechanical ventilation for their life support. NOTE 1 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support. NOTE 2 In the HOME HEALTHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable. NOTE 3 Such VENTILATORS can also be used in non-critical care applications of professional health care facilities. This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, and 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 part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, high-frequency jet ventilators (HFJVs), and high-frequency oscillatory ventilators (HFOVs)[35]. This part of ISO 80601 does not specify the requirements for cuirass and \"iron-lung\" VENTILATORS. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications, which are given in ISO 80601-2-12. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for 2 © ISO 2015 - All rights reserved anaesthetic applications, which are given in ISO 80601-2-13. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-3. NOTE 5 In the future, ISO 10651-3 is expected to be harmonized with IEC 60601-1:2005, at which time it will be replaced by ISO 80601-2-xx. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing PATIENTS), which are given in ISO 10651-6. NOTE 6 In the future, ISO 10651-6 is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2015, at which time it will be replaced by ISO 80601-2-xx. This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601-2-70.[16] This part of ISO 80601 is a particular International Standard in the IEC 60601-1 and ISO/IEC 80601 series of standards. 201.1.2 Object IEC 60601-1:2005+AMD1:2012, 1.2 is replaced by: The object of this part of ISO 80601 is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a VENTILATOR, as defined in 201.3.217, and its ACCESSORIES. NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a VENTILATOR.