ISO 11197:2019

$46.15

Medical supply units

Published By	Publication Date	Number of Pages
ISO	2019-11	44

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, ISO

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Description

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

This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.

This document 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 document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).

NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2019-11
Pages Count	44
Language	France
Edition	4
File Size	1.2 MB
ICS Codes	11.040.10 - Anaesthetic, respiratory and reanimation equipment

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ISO 11197:2019

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