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Glavni meni

ISO 11197:2016

Medical supply units
11. 2. 2016.
95.99   Povučen   7. 11. 2019.

Опште информације

95.99     7. 11. 2019.

ISO

ISO/TC 121/SC 6

Međunarodni standard

11.040.10  

engleski   francuski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11197:2004

TRENUTNO

POVUČEN
ISO 11197:2016
95.99 Povučen
7. 11. 2019.

REVIDIRAN OD

OBJAVLJEN
ISO 11197:2019

Nacionalna preuzimanja

Jedinice za napajanje u medicini

60.60   Standard objavljen