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

Current

Current

The latest, up-to-date edition.

Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

01-01-2017

€169.59
Excluding VAT

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.

DevelopmentNote
Supersedes CSA Z17510.1. (07/2017)
DocumentType
Standard
ISBN
978-1-4883-1132-1
Pages
70
PublisherName
Canadian Standards Association
Status
Current
Supersedes

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].

CSA C22.2 No. 60601-1-11 : 2015 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
ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
DIN 45681:2005-03 ACOUSTICS - DETERMINATION OF TONAL COMPONENTS OF NOISE AND DETERMINATION OF A TONE ADJUSTMENT FOR THE ASSESSMENT OF NOISE IMMISSIONS
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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