EN ISO 80601-2-69:2014

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.
ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO 80601-2-69:2014)

IEC 60601-1:2005+Änderung 1:2012, 1.1 wird ersetzt durch:
Diese besondere Norm legt Anforderungen an die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines SAUERSTOFF-KONZENTRATORS zusammen mit dessen ZUBEHÖR fest, nachfolgend als ME-GERÄT bezeichnet, der dafür vorgesehen ist, die Sauerstoffkonzentration des Gases zu erhöhen, das einem einzelnen PATIENTEN zugeführt werden soll. Derartige SAUERSTOFF-KONZENTRATOREN sind typischerweise für den Einsatz bei der MEDIZINISCHEN VERSORGUNG in HÄUSLICHER UMGEBUNG vorgesehen, einschließlich der Verwendung durch einen einzelnen PATIENTEN bei Bewegung (BETRIEBSFÄHIG BEI BEWEGUNG) in verschiedenen Umgebungen, wie privater und öffentlicher Transport, sowie zur Verwendung in Verkehrsflugzeugen.
ANMERKUNG 1   Ein solcher SAUERSTOFF-KONZENTRATOR kann auch in professionellen Einrichtungen zur Gesundheitsfürsorge angewendet werden.
Diese besondere Norm gilt für BEI BEWEGUNG BETRIEBSFÄHIGE und BEI BEWEGUNG nicht BETRIEBSFÄHIGE SAUERSTOFF-KONZENTRATOREN. Diese besondere Norm ist auf einen SAUERSTOFF-KONZENTRATOR anwendbar, der in andere medizinische Geräte, ME-GERÄTE oder in ME-SYSTEME eingebaut ist oder zusammen mit diesen benutzt wird.
BEISPIEL 1   Ein SAUERSTOFF-KONZENTRATOR mit eingebauter SAUERSTOFF-DOSIEREINRICHTUNG [10] oder mit Anfeuchter [4].
BEISPIEL 2   Ein SAUERSTOFF-KONZENTRATOR in Verwendung mit einem Durchflussmesser.
BEISPIEL 3   Ein SAUERSTOFF-KONZENTRATOR als Teil eines Anästhesiesystems zur Verwendung in Gebieten mit eingeschränkter Bereitstellung von Strom und Anästhesiegasen [3].
BEISPIEL 4   Ein SAUERSTOFF-KONZENTRATOR mit eingebautem Flüssigkeitsreservoir oder Gasflaschenfüllsystem.
Diese besondere Norm gilt auch für jenes ZUBEHÖR, das vom HERSTELLER des ZUBEHÖRS für den Anschluss an einen SAUERSTOFF-KONZENTRATOR vorgesehen ist, wenn die Eigenschaften dieses ZUBEHÖRS die BASISSICHERHEIT oder die WESENTLICHEN LEISTUNGSMERKMALE des SAUERSTOFF-KONZENTRATORS beeinträchtigen können.
Diese besondere Norm legt nicht die Anforderungen an SAUERSTOFF-KONZENTRATOREN zur Verwendung mit einem ROHRLEITUNGSSYSTEM FÜR MEDIZINISCHE GASE fest, die ISO 10083 zu entnehmen sind.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME-GERÄTE oder ME-SYSTEME vorgesehen, ist das aus der Überschrift und dem Inhalt des Abschnitts oder Unterabschnitts ersichtlich. Ist das nicht der Fall, trifft gegebenenfalls der Abschnitt oder Unterabschnitt auf das ME-GERÄT und das ME SYSTEM zu.
Die mit der physiologischen Funktion des ME-GERÄTS oder ME-SYSTEMS innerhalb des Anwendungsbereiches dieser Norm direkt verbundenen GEFÄHRDUNGEN werden nicht in spezifischen Anforderungen dieser Norm berücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der allgemeinen Norm.
ANMERKUNG 2   Siehe auch 4.2 der allgemeinen Norm.
Diese Internationale Norm ist eine besondere Norm in der IEC 60601-1-Normenreihe.

Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO 80601-2-69:2014)

L'ISO 80601-2-69:2014 spécifie les exigences applicables à la sécurité de base et aux performances essentielles d'un concentrateur d'oxygène en combinaison avec ses accessoires, désigné ci-après sous le terme d'appareil em, visant à augmenter la concentration en oxygène du gaz destiné à être délivré à un patient unique. De tels concentrateurs d'oxygène sont, en général, destinés à être utilisés dans un environnement de soins à domicile, et sont également opérationnels en déplacement pour un patient unique dans divers environnements, dans les transports publics et privés ainsi que dans les transports aériens.
L'ISO 80601-2-69:2014 est applicable aux concentrateurs d'oxygène opérationnels en déplacement et non opérationnels en déplacement. Elle est applicable aux concentrateurs d'oxygène intégrés ou utilisés avec d'autres dispositifs médicaux, appareils em ou systèmes em.

Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za koncentriranje kisika (ISO 80601-2-69:2014)

Standard EN ISO 80601-2-69 določa zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV ZA KONCENTRIRANJE KISIKA v kombinaciji s PRIPOMOČKI, v nadaljevanju MEDICINSKI PRIPOMOČKI, ki so namenjeni za povečanje koncentracije kisika v plinu, ki ga prejema PACIENT. Takšne NAPRAVE ZA KONCENTRIRANJE KISIKA se običajno uporabljajo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE, vključno z DELOVANJEM MED NOŠNJO s strani PACIENTA v različnih okoljih, tako v osebnih in javnih prevozih ter komercialnih prevozih, kot so letala.

General Information

• Status: Withdrawn
• Publication Date: 15-Jul-2014
• Withdrawal Date: 17-Nov-2020
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 18-Nov-2020
• 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 80601-2-69:2014 - Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

Relations

• Replaces: EN ISO 8359:2009/A1:2012 - Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)
• Effective Date: 23-Jul-2014
• Replaces: EN ISO 8359:2009 - Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
• Effective Date: 23-Jul-2014
• Replaced By: EN ISO 80601-2-69:2020 - Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2014
1DGRPHãþD
SIST EN ISO 8359:2009
SIST EN ISO 8359:2009/A1:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DNRQFHQWULUDQMHNLVLND,62
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and
essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO
80601-2-69:2014)
Appareils électromédicaux - Partie 2-63 : exigences particulières pour la sécurité de
base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO
80601-2-69:2014)
Ta slovenski standard je istoveten z: EN ISO 80601-2-69:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 80601-2-69
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.040.10 Supersedes EN ISO 8359:2009
English Version
Medical electrical equipment - Part 2-69: Particular requirements
for basic safety and essential performance of oxygen
concentrator equipment (ISO 80601-2-69:2014)
Appareils électromédicaux - Partie 2-69: Exigences Medizinische elektrische Geräte - Teil 2-69: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs concentrateurs d'oxygène (ISO wesentlichen Leistungsmerkmale für Sauerstoff-
80601-2-69:2014) Konzentratoren (ISO 80601-2-69:2014)
This European Standard was approved by CEN on 28 May 2014.

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-CENELEC 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-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, 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-69:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 80601-2-69:2014) 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by July 2017.
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 8359:2009.
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(s).
For relationship with EU Directive(s), 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, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-69:2014 has been approved by CEN as EN ISO 80601-2-69:2014 without any
modification.
Annex ZA
(informative)
Relationship between this Document and
the Essential Requirements of EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).
Once this document is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.11.6.4, 201.11.6.6 7.2 Only the parts of ER 7.2 relating to
safety in use for the PATIENT are
addressed.
201.11.6.4, 201.11.6.6 7.3 Only the part of the first sentence
of ER 7.3 relating to design is
addressed.
201.11.6.4 7.5
201.11 7.6
201.11.6.6, 201.11.6.7 8.1 The part of ER 8.1 relating to easy
handling is not addressed.
201.11.6.7 8.4 Validated processes for
sterilization are required via the
normative references to
ISO 11135-1, ISO 11137-1 and
ISO 17665-1.
201.4.6, 201.7.2.4.101, 9.1
201.7.2.13.101, 201.7.2.17.101,
201.7.2.101, 201.7.9.2.2.101,
201.7.9.2.5.101, 201.7.9.2.14.101,
201.12.1.101, 201.12.1.102,
201.12.1.103, 201.16, 201.101,
201.102
201.9, 202, 206, 211 9.2 The 4th indent of ER 9.2 is not
addressed.
201.11 9.3
201.12.1, 201.102 10.1 The part of ER 10.1 relating to
stability is not addressed.
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.7, 201.12.1, 206, 208 10.2
201.7.4.3 10.3
201.14 12.1
201.14 12.1 a)
202 12.5
201.8 12.6
201.9, 211 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.101, 201.15, 201.103 12.7.4
201.11 12.7.5
201.12.1 12.8.1 Only the protection of the PATIENT
is covered.
201.12.4 12.8.2 Only the first sentence of ER

12.8.2 is covered.
201.7, 206 12.9
201.7, 201.11.6.4 13.1
201.7.2.1, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101,
201.8, 201.9, 201.11.6.4
201.7.9.1 13.3 a)
201.7.2.17.101 13.3 b)
201.7, 201.7.2.17.101 a) 13.3 c)
201.7.2.17.101 13.3 d) Is only covered if the batch number
is preceded by the word LOT.
201.7.2.17.101 13.3 f)
201.7.2.101 a), 211 13.3 i)
201.7.2.101 b), 201.7.2.101 d), 211 13.3 j)
201.7.2.101 b) 13.3 k)
201.7, 201.7.2.17.101 a) 13.3 m) Presumption of conformity is only
provided if one of the symbols 5.21
to 5.24 from ISO 15223-1:2012 are

utilized, as applicable.
201.7.9.1, 201.7.9.2, 201.16 13.6 a)
201.7.9.2.5.101 13.6 b)
201.7.9.2.14.101, 201.16, 201.102 13.6 c)
201.7, 201.7.9.2.8.101, 13.6 d)
201.7.9.2.13.101, 201.16
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.16 13.6 f)
201.7.9.2.1.101, 201.7.9.2.12, 13.6 h)
201.16, 211
201.7 13.6 i)
211 13.6 k)
211 13.6 k)
211 13.6 l)
211 13.6 n)
201.12.1.103, 211 13.6 p)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this European Standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant
essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than essential requirements of Directive 93/42/EEC along with the corresponding clauses of this
European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery
directive and thus does not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that are
addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) EHSR of 2006/42/EC Qualifying remarks/Notes
of this EN
— 1.1.4 This relevant EHSR is not
covered by this European
Standard.
201.12.1, 201.12.101 1.2.2
201.7.2.101 c), 201.7.2.101 d), 1.5.4
201.101
— 1.6.2 This relevant EHSR is not
covered by this European
Standard.
201.8 1.6.3
INTERNATIONAL ISO
STANDARD 80601-2-69
First edition
2014-07-15
Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety
and essential performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et
les performances essentielles des dispositifs concentrateurs
d'oxygène
Reference number
ISO 80601-2-69:2014(E)
©
ISO 2014
ISO 80601-2-69:2014(E)
©  ISO 2014
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Published in Switzerland
ii
ISO 80601-2-69:2014(E)
Contents Page
Foreword . 5
Introduction . 7
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing of ME EQUIPMENT . 6
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
201.7 ME EQUIPMENT identification, marking and documents . 6
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 20
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Outlet connector . 21
201.102 Requirements for parts and ACCESSORIES . 21
201.102.1  * General .
...