NF EN ISO 8185
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995. ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes. NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1. ISO 8185:2007 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. It is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance. Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, ISO 8185:2007 has been prepared as a particular standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. ISO 8185:2007 is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.
ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995.
ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.
NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1.
ISO 8185:2007 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. It is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance.
Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, ISO 8185:2007 has been prepared as a particular standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity.
ISO 8185:2007 is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.
Le présent document donne les spécifications des humidificateurs à énergie pneumatique ou électrique. Les échangeurs de chaleur et d'humidité font l'objet d'une norme supplémentaire ainsi que les nébuliseurs.
<p>ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995.</p> <p>ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.</p> <p>NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1. </p> <p>ISO 8185:2007 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. It is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance. </p> <p>Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, ISO 8185:2007 has been prepared as a particular standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. </p> <p>ISO 8185:2007 is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.</p> <p>ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.</p>
- Avant-proposv
- Introductionvi
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1 Domaine d'application1
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2 Références normatives2
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3 Termes et définitions2
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4 Prescriptions générales et prescriptions relatives aux essais4
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5 Classification5
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6 Identification, marquage et documents d'accompagnement5
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7 Puissance absorbée7
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8 Catégories fondamentales de sécurité7
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9 Moyens de protection amovibles7
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10 Conditions d'environnement8
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11 Non utilisé8
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12 Non utilisé8
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13 Généralités8
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14 Prescriptions relatives à la classification8
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15 Limitation des tensions et/ou de l'énergie8
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16 Enveloppes et capots de protection8
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17 Séparation8
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18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels9
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19 Courants de fuite permanents et courant auxiliaire patient9
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20 Tension de tenue9
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21 Résistance mécanique9
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22 Parties en mouvement9
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23 Surfaces, angles et arêtes9
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24 Stabilité en utilisation normale9
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25 Projections d'objets9
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26 Vibrations et bruit9
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27 Puissance pneumatique et puissance hydraulique10
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28 Masses suspendues10
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29 Rayonnements X10
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30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules10
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31 Rayonnements à micro-ondes10
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32 Rayonnements lumineux (y compris les rayonnements lasers)10
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33 Rayonnements infrarouges10
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34 Rayonnements ultraviolets10
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35 Énergie acoustique (y compris les ultrasons)10
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36 Compatibilité électromagnétique11
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37 Localisation et prescriptions fondamentales11
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38 Marquage et documents d'accompagnement11
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39 Prescriptions communes aux appareils de la catégorie AP et de la catégorie APG11
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40 Prescriptions et essais pour les appareils de la catégorie AP, parties et composants de ceux-ci11
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41 Prescriptions et essais pour les appareils de la catégorie APG, parties d'appareils et composants de ceux-ci12
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42 Températures excessives12
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43 Prévention du feu12
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44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation et désinfection13
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45 Réservoirs et parties sous pression13
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46 Erreurs humaines13
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47 Charges électrostatiques14
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48 Matériaux des parties appliquées en contact avec le corps du patient14
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49 Coupure de l'alimentation14
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50 Précision des caractéristiques de fonctionnement14
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51 Protection contre les caractéristiques de sortie présentant des risques15
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52 Fonctionnement anormal et conditions de défaut16
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53 Essais d'environnement16
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54 Généralités16
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55 Enveloppes et capots16
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56 Composants et ensembles16
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57 Parties reliées au réseau, composants et montage18
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58 Mise à la terre de protection - Bornes et raccordements18
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59 Construction et montage18
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101 Quantité délivrée par le système d'humidification18
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102 Conteneur de liquide19
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103 Systèmes d'alarme19
- Annexe AA (informative) Justification20
- Annexe BB (normative) Détermination de l'exactitude de la température affichée28
- Annexe CC (informative) Calculs de l'enthalpie massique30
- Annexe DD (normative) Capteurs de température et orifices de raccordement36
- Annexe EE (normative) Détermination de la quantité délivrée par le système d'humidification38
- Annexe FF (normative) Capteur de température standard41
- Annexe GG (informative) Aspects environnementaux43
- Annexe HH (informative) Référence aux principes essentiels46
- Annexe II (informative) Terminologie - Index des termes définis48
- Bibliographie50
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