NF EN ISO 8359/A1

November 2012

Standard Cancelled

Oxygen concentrators for medical use - Safety requirements - Amendment 1

Le présent document amende la norme NF EN ISO 8359, de juillet 2009. Il fixe les spécifications de sécurité électrique, les caractéristiques de fonctionnement et les indications à fournir par le fabricant pour les concentrateurs d'oxygène utilisés principalement à domicile. Le présent document ne s'applique pas aux concentrateurs d'oxygène utilisés pour alimenter les systèmes de distribution de gaz médicaux.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2012

Number of pages

10 p.

Reference

NF EN ISO 8359/A1

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

Classification index

S95-143/A1

Print number

1 - 09/10/2012

International kinship

ISO 8359/A1:2012

European kinship

EN ISO 8359/A1:2012

Sumary

Oxygen concentrators for medical use - Safety requirements - Amendment 1

Le présent document amende la norme NF EN ISO 8359, de juillet 2009. Il fixe les spécifications de sécurité électrique, les caractéristiques de fonctionnement et les indications à fournir par le fabricant pour les concentrateurs d'oxygène utilisés principalement à domicile. Le présent document ne s'applique pas aux concentrateurs d'oxygène utilisés pour alimenter les systèmes de distribution de gaz médicaux.

Standard replaced by (1)

NF EN ISO 80601-2-69

October 2014

Standard Cancelled

Medical electrical equipment - Part 2-69 : particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft. ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

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