NF EN ISO 8185

NF EN ISO 8185

September 2007
Standard Cancelled

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.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2007

Number of pages

65 p.

Reference

NF EN ISO 8185

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-150

Print number

1 - 03/09/2007

International kinship

ISO 8185:2007

European kinship

EN ISO 8185:2007
Sumary
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.

Replaced standards (1)
NF EN ISO 8185
January 1998
Standard Cancelled
Humidifiers for medical use. General requirements for humidification systems.

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.

Standard replaced by (1)
NF EN ISO 8185
July 2009
Standard Cancelled
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems

<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>

Table of contents
View the extract
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    2
  • 3 Termes et définitions
    2
  • 4 Prescriptions générales et prescriptions relatives aux essais
    4
  • 5 Classification
    5
  • 6 Identification, marquage et documents d'accompagnement
    5
  • 7 Puissance absorbée
    7
  • 8 Catégories fondamentales de sécurité
    7
  • 9 Moyens de protection amovibles
    7
  • 10 Conditions d'environnement
    8
  • 11 Non utilisé
    8
  • 12 Non utilisé
    8
  • 13 Généralités
    8
  • 14 Prescriptions relatives à la classification
    8
  • 15 Limitation des tensions et/ou de l'énergie
    8
  • 16 Enveloppes et capots de protection
    8
  • 17 Séparation
    8
  • 18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels
    9
  • 19 Courants de fuite permanents et courant auxiliaire patient
    9
  • 20 Tension de tenue
    9
  • 21 Résistance mécanique
    9
  • 22 Parties en mouvement
    9
  • 23 Surfaces, angles et arêtes
    9
  • 24 Stabilité en utilisation normale
    9
  • 25 Projections d'objets
    9
  • 26 Vibrations et bruit
    9
  • 27 Puissance pneumatique et puissance hydraulique
    10
  • 28 Masses suspendues
    10
  • 29 Rayonnements X
    10
  • 30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules
    10
  • 31 Rayonnements à micro-ondes
    10
  • 32 Rayonnements lumineux (y compris les rayonnements lasers)
    10
  • 33 Rayonnements infrarouges
    10
  • 34 Rayonnements ultraviolets
    10
  • 35 Énergie acoustique (y compris les ultrasons)
    10
  • 36 Compatibilité électromagnétique
    11
  • 37 Localisation et prescriptions fondamentales
    11
  • 38 Marquage et documents d'accompagnement
    11
  • 39 Prescriptions communes aux appareils de la catégorie AP et de la catégorie APG
    11
  • 40 Prescriptions et essais pour les appareils de la catégorie AP, parties et composants de ceux-ci
    11
  • 41 Prescriptions et essais pour les appareils de la catégorie APG, parties d'appareils et composants de ceux-ci
    12
  • 42 Températures excessives
    12
  • 43 Prévention du feu
    12
  • 44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation et désinfection
    13
  • 45 Réservoirs et parties sous pression
    13
  • 46 Erreurs humaines
    13
  • 47 Charges électrostatiques
    14
  • 48 Matériaux des parties appliquées en contact avec le corps du patient
    14
  • 49 Coupure de l'alimentation
    14
  • 50 Précision des caractéristiques de fonctionnement
    14
  • 51 Protection contre les caractéristiques de sortie présentant des risques
    15
  • 52 Fonctionnement anormal et conditions de défaut
    16
  • 53 Essais d'environnement
    16
  • 54 Généralités
    16
  • 55 Enveloppes et capots
    16
  • 56 Composants et ensembles
    16
  • 57 Parties reliées au réseau, composants et montage
    18
  • 58 Mise à la terre de protection - Bornes et raccordements
    18
  • 59 Construction et montage
    18
  • 101 Quantité délivrée par le système d'humidification
    18
  • 102 Conteneur de liquide
    19
  • 103 Systèmes d'alarme
    19
  • Annexe AA (informative) Justification
    20
  • Annexe BB (normative) Détermination de l'exactitude de la température affichée
    28
  • Annexe CC (informative) Calculs de l'enthalpie massique
    30
  • Annexe DD (normative) Capteurs de température et orifices de raccordement
    36
  • Annexe EE (normative) Détermination de la quantité délivrée par le système d'humidification
    38
  • Annexe FF (normative) Capteur de température standard
    41
  • Annexe GG (informative) Aspects environnementaux
    43
  • Annexe HH (informative) Référence aux principes essentiels
    46
  • Annexe II (informative) Terminologie - Index des termes définis
    48
  • Bibliographie
    50
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