• There are no items in your cart

NF EN ISO 17510-1 : 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT

Superseded date

10-22-2021

Published date

01-12-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Exigences
5 Classification et désignation
6 Marquage, étiquetage et emballage
7 Puissance absorbée
8 Catégories fondamentales de sécurité
9 Moyens de protection amovibles
10 Conditions d'environnement
11 Non utilisé
12 Non utilisé
13 Généralités
14 Exigences relatives à la classification
15 Limitation de la tension et/ou de l'énergie
16 Enveloppes et capots de protection
17 Séparation
18 Mise à la terre de protection, mise à la terre
   fonctionnelle et égalisation des potentiels
19 Courants de fuite permanents et courant auxiliaire
   patient
20 Tension de tenue
21 Résistance mécanique
22 Parties en mouvement
23 Surfaces, angles et arêtes
24 Stabilité en utilisation normale
25 Projection d'objets
26 Vibrations et bruit
27 Puissance pneumatique et puissance hydraulique
28 Masses suspendues
29 Rayonnements X
30 Rayonnements alpha, bêta, gamma, neutroniques et
   d'autres particules
31 Rayonnements à micro-ondes
32 Rayonnements lumineux (y compris les rayonnements
   lasers)
33 Rayonnements infrarouges
34 Rayonnements ultraviolets
35 Énergie acoustique (y compris les ultrasons)
36 Compatibilité électromagnétique
37 Localisations et exigences fondamentales
38 Marquage et documents d'accompagnement
39 Exigences communes aux appareils de la catégorie
   AP et de la catégorie APG
40 Exigences et essais pour les appareils de la catégorie
   AP, parties et composants de ceux-ci
41 Exigences et essais pour les appareils de la catégorie
   APG, parties et composants de ceux-ci
42 Températures excessives
43 Prévention du feu
44 Débordements, renversements, fuites, humidité,
   pénétration de liquides, nettoyage, stérilisation
   et désinfection
45 Réservoirs et parties sous pression
46 Erreurs humaines
47 Charges électrostatiques
48 Biocompatibilité
49 Coupure de l'alimentation électrique
50 Précision des caractéristiques de fonctionnement
51 Protection contre les caractéristiques de sortie
   présentant des risques
52 Fonctionnement anormal et conditions de défauts
53 Essais d'environnement
54 Généralités
55 Enveloppes et capots
56 Composants et ensembles
57 Parties reliées au réseau, composants et montage
58 Mise à la terre de protection - Bornes et raccordements
59 Construction et montage
Annexe AA (informative) Exposé des motifs
Annexe BB (normative) Méthodes d'essai portant sur
          l'exactitude de la pression en utilisation
          normale
Annexe CC (normative) Méthode d'essai du débit maximal
Annexe DD (informative) Aspects environnementaux
Annexe EE (informative) Référence aux principes essentiels
Annexe FF (informative) Terminologie - Index alphabétique
          des termes définis
Bibliographie

Describes requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.

DevelopmentNote
Indice de classement: S95-182-1. Supersedes NFS 95 182. (09/2003) PR NF EN ISO 17510-1 January 2006. (01/2006) PR NF EN ISO 17510-1 January 2009. (01/2009)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded
SupersededBy
Supersedes

NF EN 60601-1-6 : 2010 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
NF EN ISO 5356-1 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS
NF EN ISO 3744 : 2012 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS AND SOUND ENERGY LEVELS OF NOISE SOURCES USING SOUND PRESSURE - ENGINEERING METHODS FOR AN ESSENTIALLY FREE FIELD OVER A REFLECTING PLANE
NF EN ISO 23328-1 : 2008 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NF EN ISO 23328-2 : 2009 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
NF EN ISO 5356-2 : 2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS
NF EN ISO 9170-1 : 2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
NF EN 60529 : 92 AMD 2 2014 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE)
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
NF EN 60601-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
NF EN ISO 14937 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
NFT 20 037 : 1985 CHEMICAL PRODUCTS OF INDUSTRIAL USE - DETERMINATION OF TEMPERATURE OF AUTO-INFLAMMATION OF VOLATILE LIQUIDS AND GASES
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
NF EN ISO 4871 : 2009 ACOUSTICS - DECLARATION AND VERIFICATION OF NOISE EMISSION VALUES OF MACHINERY AND EQUIPMENT
NF EN ISO 4135 : 2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
NF EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
NF EN ISO 17510-2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
NF EN ISO 17665 : 2004 PR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
NF EN 60601-1-1 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.