CSA Group Medical supply units ISO 11197:2016

Description
IEC 60601-1:2005+A1:2012 , 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012 , 4.2.
  • Medical supply units - ISO 11197:2016 - CSA Group
    CSA Group
Description
IEC 60601-1:2005+A1:2012 , 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012 , 4.2.

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Medical supply units - ISO 11197:2016 - CSA Group
CSA Group
Toronto, Ontario, Canada
Medical supply units
ISO 11197:2016
Medical supply units ISO 11197:2016
IEC 60601-1:2005+A1:2012 , 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012 , 4.2.

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.

ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.

NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.

Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).

NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

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Technical Specifications

  CSA Group
Product Category Standards and Technical Documents
Product Number ISO 11197:2016
Product Name Medical supply units
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