SIST EN ISO 5359:2015/A1:2018

Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)

2017-08-31 - BTC 110/2017 - BT approve publication of EN ISO with modified Annex ZA & Foreword
2017-08-08 - Cannot allocate for publication due to negative assessment from Consultant.
CEN/BT C082/2011:  DOW = DAV + 36 months

Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO 5359:2014/Amd 1:2017)

Matériel d'anésthésie et de réanimation respiratoire - Flexibles de raccordement à basse pression pour utilisation avec les gaz médicaux (ISO 5359:2014/Amd 1:2017)

Anestezijska in dihalna oprema - Nizkotlačne povezovalne cevi za delo z medicinskimi plini - Dopolnilo A1 (ISO 5359:2014/Amd 1:2017)

General Information

• Status: Published
• Public Enquiry End Date: 14-Sep-2015
• Publication Date: 08-Jan-2018
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 83.140.40 - Hoses
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Dec-2017
• Due Date: 12-Feb-2018
• Completion Date: 09-Jan-2018
• 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: EN ISO 5359:2014/A1:2017 - Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)

Relations

• Amends: SIST EN ISO 5359:2015 - Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014)
• Effective Date: 01-Feb-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5359:2015/A1:2018
01-februar-2018
$QHVWH]LMVNDLQGLKDOQDRSUHPD1L]NRWODþQHSRYH]RYDOQHFHYL]DGHOR]
PHGLFLQVNLPLSOLQL'RSROQLOR$,62$PG
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with
medical gases - Amendment 1 (ISO 5359:2014/Amd 1:2017)
Anästhesie- und Beatmungsgeräte - Niederdruck-Schlauchleitungssysteme zur
Verwendung mit medizinischen Gasen (ISO 5359:2014/Amd 1:2017)
Matériel d'anésthésie et de réanimation respiratoire - Flexibles de raccordement à basse
pression pour utilisation avec les gaz médicaux (ISO 5359:2014/Amd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 5359:2014/A1:2017
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
83.140.40 Gumene cevi Hoses
SIST EN ISO 5359:2015/A1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5359:2015/A1:2018

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SIST EN ISO 5359:2015/A1:2018


EN ISO 5359:2014/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2017
EUROPÄISCHE NORM
ICS 83.140.40; 11.040.10
English Version

Anaesthetic and respiratory equipment - Low-pressure
hose assemblies for use with medical gases - Amendment
1 (ISO 5359:2014/Amd 1:2017)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Niederdruck-
Flexibles de raccordement à basse pression pour Schlauchleitungssysteme zur Verwendung mit
utilisation avec les gaz médicaux - Amendement 1 (ISO medizinischen Gasen - Änderung 1 (ISO
5359:2014/Amd 1:2017) 5359:2014/Amd 1:2017)
This amendment A1 modifies the European Standard EN ISO 5359:2014; it was approved by CEN on 16 August 2017.

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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5359:2014/A1:2017 E
worldwide for CEN national Members.

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SIST EN ISO 5359:2015/A1:2018
EN ISO 5359:2014/A1:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

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SIST EN ISO 5359:2015/A1:2018
EN ISO 5359:2014/A1:2017 (E)
European foreword
The text of this Amendment EN ISO 5359:2014/A1:2017 to the EN ISO 5359:2014 from Technical
Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for
Standardization (ISO) has been taken over as an amendment to the European Standard by Technical
Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by
BSI.
This Amendment to the European Standard EN ISO 5359:2014 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2018, and
conflicting national standards shall be withdrawn at the latest by November 2020.
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.
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 EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative
Equivalent dated standard
references
EN ISO
as listed in Clause 2 of the
ISO standard
ISO 1307:2006 EN ISO 1307:2008 ISO 1307:2006
ISO 1402:2009 EN ISO 1402:2009 ISO 1402:2009
ISO 8033:2006 EN ISO 8033:2006 ISO 8033:2006
ISO 9170-1:2008 EN ISO 9170-1:2008 ISO 9170-1:2008
ISO 14155:2011 EN ISO 14155:2011 ISO 14155:2011
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
ISO 15001:2010 EN ISO 15001:2011 ISO 15001:2010
3

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SIST EN ISO 5359:2015/A1:2018
EN ISO 5359:2014/A1:2017 (E)
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,
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 the United Kingdom.
Endorsement notice
The text of ISO 5359:2014/Amd 1:2017 has been approved by CEN as EN ISO 5359:2014/A1:2017
without any modification.
4

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SIST EN ISO 5359:2015/A1:2018
EN ISO 5359:2014/A1:2017 (E)
Annex ZA
(informative)

Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under
...