SK EN ISO 11197:2017

Status: Withdrawn
Gjuha: English
Faqe: 33
Publikuar: 2017-12-01
I tërhequr: 2022-04-04
Regjistri Kombëtar: 213/2017
Botim:

Standardet ndërkombëtare që kanë lidhje

This standard is identical to:
EN ISO 11197:2016
CEN/TC 215

Çmim: 31 €

Titulli Shqip

Njësitë mjekësore të zbatimit

Titulli Anglisht

Medical supply units (ISO 11197:2016)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

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.