Standard Svensk standard · SS-EN ISO 11197:2019

Medicinska försörjningsenheter (ISO 11197:2019)

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Standard Svensk standard · SS-EN ISO 11197:2019

Medicinska försörjningsenheter (ISO 11197:2019)
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Omfattning
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.

Ämnesområden

Medicinsk utrustning allmänt (11.040.01) Utrustning för anestesi, respiration och återupplivning (11.040.10)


Köp denna standard

Standard Svensk standard · SS-EN ISO 11197:2019

Medicinska försörjningsenheter (ISO 11197:2019)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 140 SEK
standard ikon pdf

PDF

Pris: 1 140 SEK
standard ikon

Papper

Pris: 1 824 SEK
standard ikon pdf + standard ikon

PDF + papper

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Produktinformation

Språk: Engelska

Framtagen av: Anestesi- och respiratorutrustning, SIS/TK 329

Internationell titel: Medical supply units (ISO 11197:2019)

Artikelnummer: STD-80018377

Utgåva: 4

Fastställd: 2019-12-02

Antal sidor: 48

Ersätter: SS-EN ISO 11197:2016