CAN/CSA-C22.2 NO. 80601-2-70:17

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 BREATHING GAS PATHWAY connectors
201.102 Requirements for the BREATHING GAS PATHWAY
        and ACCESSORIES
201.103 FUNCTIONAL CONNECTION
201.104 Training
202 Medical electrical equipment - Part 1-2: General
        requirements for basic safety and essential performance -
        Collateral standard: Electromagnetic disturbances -
        Requirements and tests
206 Medical electrical equipment - Part 1-6: General
        requirements for basic safety and essential performance -
        Collateral Standard: Usability
208 Medical electrical equipment - Part 1-8: General
        requirements for basic safety and essential performance -
        Collateral Standard: General requirements, tests and
        guidance for alarm systems in medical electrical
        equipment and medical electrical systems
211 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
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
Bibliography
Alphabetized index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the PATIENT.

Preface This is the first edition of CAN/CSA-C22.2 No. 80601-2-70, Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment, which is an adoption, with Canadian deviations, of the identically titled ISO International Organization for Standardization) Standard 80601-2-70 (first edition, 2015-01). It replaces CAN/CSA-Z17510-1:10, Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (adopted ISO 17510-1:2007). 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. 80601-2-70\" 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+A1:2012, Clause 1 applies, except as follows: 3201.1.1 * Scope IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the PATIENT. SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for use in the HOME HEALTHCARE ENVIRONMENT by LAY OPERATORS as well as in professional healthcare institutions. This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with neonates. This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are not dependent on mechanical ventilation. This particular standard is not applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are dependent on mechanical ventilation such as PATIENTS with central sleep apnoea. This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to SLEEP APNOEA BREATHING THERAPY EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT. MASKS and application ACCESSORIES intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. 3) Refer to Figure AA.1 for items covered further under this standard. 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE 4 See also 4.2 of the General Standard. This particular standard is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs).[16] This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for critical care ventilators for ventilator-dependent PATIENTS which are given in ISO 80601-2-12. This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for anaesthetic applications which are given in IEC 80601-2-13. This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-24). This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for emergency and transport which are given in ISO 10651-35). This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for homecare ventilatory support devices which are given in ISO 10651-66). This particular standard is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards. 201.1.2 Object IEC 60601-1:2005, 1.2 is replaced by: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SLEEP APNOEA BREATHING THERAPY EQUIPMENT [as defined in 201.3.212].