Skip to main content
Tagasi

EVS-EN ISO 15001:2011

Anesteesia- ja hingamisseadmed. Sobivus hapnikuga kasutamiseks (ISO 15001:2010)

Üldinfo

Kehtiv alates 02.11.2011
Alusdokumendid
ISO 15001:2010; EN ISO 15001:2011
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
02.11.2011
Põhitekst
This International Standard specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa. Additionally, this International Standard gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition. Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages. This International Standard does not apply to biocompatibility. This International Standard is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.

Nõutud väljad on tähistatud *

*
*
*
PDF
26,84 € koos KM-ga
Paber
26,84 € koos KM-ga
Sirvi standardit alates 2,44 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst + muudatus

EVS-EN 1041:2008+A1:2013

Tootja antav info meditsiiniseadmete kohta
Kehtetu alates 17.05.2021
Põhitekst

EVS-EN ISO 5359:2014

Anesteesia- ja hingamisaparatuur. Meditsiiniliste gaaside jaoks kasutatavad madalrõhu voolikukomplektid
Uusim versioon Kehtiv alates 07.11.2014
Põhitekst

EVS-EN ISO 7396-1:2016

Meditsiinilise gaasi torusüsteemid. Osa 1: Torustikud meditsiiniliste surugaaside ja vaakumi jaoks
Uusim versioon Kehtiv alates 04.04.2016
Põhitekst

EVS-EN ISO 9170-1:2008

Meditsiinilise gaasi torusüsteemid. Osa 1: Liitmikud kokkusurutud meditsiinilise gaasi ja vaakumi jaoks
Kehtetu alates 01.07.2020