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CEN

EN ISO 10079-1:2015/A1:2019

(Amendment)

Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating at extremes of temperature (ISO 10079-1:2015/Amd 1:2018)

Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating at extremes of temperature (ISO 10079-1:2015/Amd 1:2018)

CEN/BT C082/2011:  DOW = DAV + 36 months
TAN - Consultant assessment Rejected at FDIS stage.
2019-01-14 - JO: BT N 11332 (BT C160/2018) for CEN TC 215 to remove link from the MDD (93/42/EEC) and Mandate M/023

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte - Änderung 1: Änderungen der Anforderungen an Grenzwerte für Betriebstemperaturen (ISO 10079-1:2015/Amd 1:2018)

ISO 10079-1:2015 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.
ISO 10079-1:2015 does not apply to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;
b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) mucus extractors including neonatal mucus extractors;
i) suction equipment where the collection container is downstream of the vacuum pump;
j) ventouse (obstetric) equipment;
k) suction equipment marked for endoscopic use only;
l) plume evacuation systems.

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration - Amendement 1: Modifications des exigences de fonctionnement à des valeurs extrêmes de température (ISO 10079-1:2015/Amd 1:2018)

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema - Dopolnilo A1: Spremembe zahtev za delovanje pri ekstremnih temperaturah (ISO 10079-1:2015/Amd 1:2018)

General Information

Status
Withdrawn
Publication Date
29-Jan-2019
Withdrawal Date
29-Mar-2022
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
30-Mar-2022
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
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 10079-1:2016/A1:2019 - Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating at extremes of temperature (ISO 10079-1:2015/Amd 1:2018)

Relations

Replaced By
EN ISO 10079-1:2022 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
Effective Date
12-Aug-2020
Amends
EN ISO 10079-1:2015 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
Effective Date
08-Jun-2022

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EN ISO 10079-1:2016/A1:2019EN ISO 10079-1:2016/A1:2019
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EN ISO 10079-1:2016/A1:2019
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-1:2016/A1:2019
01-april-2019
0HGLFLQVNDVXNFLMVND DVSLUDFLMVND RSUHPDGHO(OHNWULþQDVXNFLMVND
DVSLUDFLMVND RSUHPD'RSROQLOR$6SUHPHPEH]DKWHY]DGHORYDQMHSUL
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Medical suction equipment - Part 1: Electrically powered suction equipment -
Amendment 1: Changes to requirements for operating at extremes of temperature (ISO
10079-1:2015/Amd 1:2018)
Medizinische Absauggeräte — Teil 1: Elektrisch betriebene Absauggeräte - Änderung 1:
Änderungen der Anforderungen an Grenzwerte für Betriebstemperaturen (ISO 10079-
1:2015/Amd 1:2018)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration -
Amendement 1: Modifications des exigences de fonctionnement à des valeurs extrêmes
de température (ISO 10079-1:2015/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2015/A1:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-1:2016/A1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 10079-1:2016/A1:2019

---------------------- Page: 2 ----------------------

SIST EN ISO 10079-1:2016/A1:2019


EN ISO 10079-1:2015/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2019
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Medical suction equipment - Part 1: Electrically powered
suction equipment - Amendment 1: Changes to
requirements for operating at extremes of temperature
(ISO 10079-1:2015/Amd 1:2018)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch
électriques d'aspiration - Amendement 1: betriebene Absauggeräte - Änderung 1: Änderungen
Modifications des exigences de fonctionnement à des der Anforderungen an Grenzwerte für
valeurs extrêmes de température (ISO 10079- Betriebstemperaturen (ISO 10079-1:2015/Amd
1:2015/Amd 1:2018) 1:2018)
This amendment A1 modifies the European Standard EN ISO 10079-1:2015; it was approved by CEN on 13 December 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This amendment 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-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2015/A1:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 10079-1:2016/A1:2019
EN ISO 10079-1:2015/A1:2019 (E)
Contents Page
European foreword . 3
2

---------------------- Page: 4 ----------------------

SIST EN ISO 10079-1:2016/A1:2019
EN ISO 10079-1:2015/A1:2019 (E)
European foreword
This document (EN ISO 10079-1:2015/A1:2019) has been prepared by Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment" in collaboration with 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 July 2019, and conflicting national standards shall be
withdrawn at the latest by July 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgar
...

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