NF EN ISO 9919

Afnor EDITIONS
Standards
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.

View the extract

Main informations

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

View the extract

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

ZOOM ON ... the Requirements department

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!

Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ