Status : Published (To be revised)

This standard will be replaced by ISO/DIS 11197
Format Language
PDF
Paper
  • CHF173
Convert Swiss francs (CHF) to your currency

Abstract

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.

Standard first page

Read sample 

Preview this standard in our Online Browsing Platform (OBP)

General information

  • Status
     : Published
    Publication date
     : 2019-11
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 4
    Number of pages
     : 36
  • Technical Committee :
    ISO/TC 121/SC 6
    ICS :
    11.040.10 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. TC
  5. ISO/TC 121/SC 6
  6. ISO 11197:2019