NF EN ISO 9919

NF EN ISO 9919

August 2009
Standard Cancelled

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.Amendment (add at the end of 1.1):ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in home care. ISO 9919:2005 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient.ISO 9919:2005 is not applicable to pulse oximeter equipment solely intended for fetal use.ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.The requirements of ISO 9919:2005 which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

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Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

105 p.

Reference

NF EN ISO 9919

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment
11.040.55   Diagnostic equipment

Classification index

S95-158

Print number

1 - 03/08/2009

International kinship

ISO 9919:2005

European kinship

EN ISO 9919:2009
Sumary
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.

Amendment (add at the end of 1.1):

ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.

These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has been reprocessed.

The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in home care.

ISO 9919:2005 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient.

ISO 9919:2005 is not applicable to pulse oximeter equipment solely intended for fetal use.

ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.

The requirements of ISO 9919:2005 which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

Replaced standards (1)
NF EN ISO 9919
August 2005
Standard Cancelled
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

Le présent document définit les prescriptions de sécurité et de performance des oxymètres de pouls utilisés chez les êtres humains.

Standard replaced by (1)
NF EN ISO 80601-2-61
December 2011
Standard Cancelled
Medical electrical equipment - Part 2-61 : particular requirements for basic safety and essential performance of pulse oximeter equipment

ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.

Table of contents
  • Avant-propos
    vii
  • Introduction
    viii
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    3
  • 4 Exigences générales et exigences relatives aux essais
    8
  • 5 Classification
    8
  • 6 Identification, marquage et documentation
    8
  • 7 Puissance absorbée
    12
  • 8 Catégories fondamentales de sécurité
    12
  • 9 Moyens de protection amovibles
    12
  • 10 Conditions d'environnement
    12
  • 11 Non utilisé
    12
  • 12 Non utilisé
    12
  • 13 Généralités
    12
  • 14 Exigences relatives à la classification
    13
  • 15 Limitation des tensions et/ou de l'énergie
    13
  • 16 Enveloppes et capots de protection
    13
  • 17 Séparation
    13
  • 18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels
    13
  • 19 Courants de fuite permanents et courant auxiliaire patient
    13
  • 20 Rigidité diélectrique
    14
  • 22 Parties en mouvement
    16
  • 23 Surfaces, angles et arêtes
    16
  • 24 Stabilité en utilisation normale
    16
  • 25 Projections d'objets
    16
  • 26 Vibrations et bruit
    16
  • 27 Puissance pneumatique et puissance hydraulique
    16
  • 28 Masses suspendues
    16
  • 29 Rayonnements X
    17
  • 30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules
    17
  • 31 Rayonnements à micro-ondes
    17
  • 32 Rayonnements lumineux (y compris les rayonnements lasers)
    17
  • 33 Rayonnements infrarouges
    17
  • 34 Rayonnements ultraviolets
    17
  • 35 Énergie acoustique (y compris les ultrasons)
    17
  • 36 Compatibilité électromagnétique
    17
  • 37 Localisation et exigences fondamentales
    18
  • 38 Marquage et documents d'accompagnement
    18
  • 39 Exigences communes aux appareils de la catégorie AP et de la catégorie APG
    18
  • 40 Exigences et essais pour les appareils de la catégorie AP, parties et composants de ceux-ci
    18
  • 41 Exigences et essais pour les appareils de la catégorie APG, parties et composants de ceux-ci
    18
  • 42 Températures excessives
    18
  • 43 Prévention du feu
    19
  • 44 Débordements, renversements, fuites, humidité, pénétration de liquide, nettoyage, stérilisation et désinfection
    20
  • 45 Réservoirs et parties sous pression
    20
  • 46 Erreurs humaines
    20
  • 47 Charges électrostatiques
    21
  • 48 Biocompatibilité
    21
  • 49 Coupure de l'alimentation
    21
  • 50 Exactitude des caractéristiques de fonctionnement
    22
  • 51 Protection contre les caractéristiques de sortie présentant des risques
    24
  • 52 Fonctionnement anormal et conditions de défaut
    25
  • 53 Essais d'environnement
    25
  • 54 Généralités
    25
  • 55 Enveloppes et capots
    25
  • 56 Composants et ensembles
    25
  • 57 Parties reliées au réseau, composants et montage
    25
  • 58 Mise à la terre de protection - Bornes et raccordements
    25
  • 59 Construction et montage
    25
  • 101 Invalidité du signal
    26
  • 102 Capteurs de l'oxymètre de pouls et câbles de raccordement du capteur
    26
  • 103 Signal d'information en cas de saturation
    27
  • 201 Systèmes d'alarme
    27
  • 105 Appendices de la IEC 60601-1:1988
    27
  • Annexe AA (informative) Justifications
    28
  • Annexe CC (informative) Détermination de l'exactitude
    44
  • Annexe DD (informative) Étalons
    54
  • Annexe EE (informative) Lignes directrices pour l'évaluation et la documentation relative à l'exactitude de la SpO2 chez des sujets humains
    55
  • Annexe FF (informative) Simulateurs, dispositifs d'étalonnage et dispositifs d'essai fonctionnel utilisés pour les oxymètres de pouls
    63
  • Annexe GG (informative) Concepts relatifs au temps de réponse du système
    74
  • Annexe HH (informative) Références aux principes essentiels
    78
  • Annexe II (informative) Aspects environnementaux
    80
  • Annexe JJ (informative) Index des termes définis
    82
  • Bibliographie
    84
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