Standard Svensk standard · SS-EN ISO 18778:2009

Monitorer för att detektera livshotande tillstånd hos spädbarn - Särskilda krav (ISO 18778:2005)

Status: Gällande

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Standard Svensk standard · SS-EN ISO 18778:2009

Monitorer för att detektera livshotande tillstånd hos spädbarn - Särskilda krav (ISO 18778:2005)
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Omfattning
IEC 60601-1:1988, Clause 1, applies except as follows: Amendments (add at end of 1.1): 1.1 This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision. This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. This International Standard does not apply to monitors intended for use in health care facilities/institutions. The requirements of this International Standard, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements.1.4 Addition: NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.

Ämnesområden

Utrustning för anestesi, respiration och återupplivning (11.040.10)


Köp denna standard

Standard Svensk standard · SS-EN ISO 18778:2009

Monitorer för att detektera livshotande tillstånd hos spädbarn - Särskilda krav (ISO 18778:2005)
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

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

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

Internationell titel:

Artikelnummer: STD-69574

Utgåva: 2

Fastställd: 2009-04-27

Antal sidor: 44

Ersätter: SS-EN ISO 18778:2005