EN ISO 10079-1:2009

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

2019-02-19 - JO - TC decision 17/2018  (BT N 11332 - BT C160/2018)  to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO.

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte - Sicherheitsanforderungen (ISO 10079-1:1999)

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration - Prescriptions de sécurité (ISO 10079-1:1999)

La présente partie de l'ISO 10079 spécifie les prescriptions minimales de sécurité et de performance relatives aux appareils d'aspiration médicale et chirurgicale utilisés dans les installations de soins, telles que les hôpitaux, pour les soins des malades à domicile et pour les soins sur le terrain ou lors du transport dans les ambulances. Bien que ces appareils puissent être mus par aspiration dans des canalisations fixes («vide central»), par des gaz comprimés, par une source électrique ou encore manuellement pour un certain nombre d'applications, la présente partie de l'ISO 10079 ne concerne que les appareils électriques branchés sur le secteur ou sur batteries. Les prescriptions de la présente Norme internationale ont priorité sur celles de la CEI 60601 -1. Le domaine d'application et l'objet donnés dans article 1 de la CEI 60601-1:1988 sont applicables, à l'exception du paragraphe 1.1 qui doit être remplacé par ce qui suit: La présente partie de l'ISO 10079 n'est pas applicable aux éléments énumérés ci-après: a) les alimentations motrices à partir d'une centrale (air comprimé/aspi ration), les systèmes de canalisations des véhicules et bâtiments, ainsi que les raccords muraux; b) les sondes d'aspiration, les drains, les curettes et les embouts d'aspiration; c) les seringues; d) les appareils dentaires d'aspiration; e) les systèmes d'évacuation des gaz; f) l'aspiration en laboratoire; g) les systèmes d'autotransfusion; h) le drainage urinaire passif; i) les systèmes clos pour drainage des plaies; j) le drainage gastrique par gravité; k) les extracteurs de mucosité par voie orale; l) les appareils d'aspiration dont le bocal de recueil est en aval de la pompe à vide; m) les appareils indiqués comme unités d'aspiration pour la trachéotomie permanente; n) les appareils avec ventouse (obstétrique); o) les extracteurs de mucosités pour nouveau-nés; p) les appareils d'aspiration à usage endoscopique uniquement (marqués comme tels).

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema - Varnostne zahteve (ISO 10079-1:1999)

General Information

• Status: Withdrawn
• Publication Date: 03-Mar-2009
• Withdrawal Date: 24-Nov-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 25-Nov-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10079-1:2009 - Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

Relations

• Replaces: EN ISO 10079-1:1999 - Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10079-1:2015 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
• Effective Date: 25-Jul-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-1:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 10079-1:2000
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO(OHNWULþQDVXNFLMVND
DVSLUDFLMVNDRSUHPD9DUQRVWQH]DKWHYH,62
Medical suction equipment - Part 1: Electrically powered suction equipment - Safety
requirements (ISO 10079-1:1999)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte -
Sicherheitsanforderungen (ISO 10079-1:1999)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration -
Prescriptions de sécurité (ISO 10079-1:1999)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10079-1:2009

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SIST EN ISO 10079-1:2009
EUROPEAN STANDARD
EN ISO 10079-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 10079-1:1999
English Version
Medical suction equipment - Part 1: Electrically powered suction
equipment - Safety requirements (ISO 10079-1:1999)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch betriebene
électriques d'aspiration - Prescriptions de sécurité (ISO Absauggeräte - Sicherheitsanforderungen (ISO 10079-
10079-1:1999) 1:1999)
This European Standard was approved by CEN on 24 February 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10079-1:2009
EN ISO 10079-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 10079-1:2009
EN ISO 10079-1:2009 (E)
Foreword
The text of ISO 10079-1:1999 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 10079-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10079-1:1999.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directives.
For relationship with EC Directives, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Gree
...