NF EN 738-4
Pressure regulators for use with medical gases. Part 4 : low-pressure regulators intended for incorporation into medical equipment.
Le présent document fait partie d'une série de normes sur détendeurs médicaux. Il fixe les caractéristiques et les essais associés des détendeurs conçus pour être incorporés dans les dispositifs médicaux afin de maintenir une pression constante à partir d'une pression d'alimentation comprise entre 280 kPa et 600 kPa.
Le présent document fait partie d'une série de normes sur détendeurs médicaux. Il fixe les caractéristiques et les essais associés des détendeurs conçus pour être incorporés dans les dispositifs médicaux afin de maintenir une pression constante à partir d'une pression d'alimentation comprise entre 280 kPa et 600 kPa.
ISO 10524-4:2008 applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows: low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3; operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.
- Avant-propos3
- Introduction4
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1 Domaine d'application4
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2 Références normatives5
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3 Définitions5
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4 Symboles et terminologie7
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5 Exigences générales7
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6 Méthodes d'essai10
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7 Marquage et emballage13
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8 Informations à fournir par le fabricant13
- Annexe A (normative) Conditions nationales particulières18
- Annexe B (informative) Exemples de détendeurs19
- Annexe C (informative) Bibliographie20
- Annexe D (informative) Justificatif21
- Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou autres dispositions des Directives de l'Union Européenne22
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