EN ISO 7199:2017
(Main)Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filter.
Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016)
Dieses Dokument legt Anforderungen an sterile extrakorporale Blutgasaustauscher (Oxygenatoren) zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in das und zur Entfernung von Kohlendioxid aus dem menschliche(n) Blut bestimmt sind.
Dieses Dokument gilt auch für Wärmeaustauscher und arterielle Filter, die in Oxygenatoren integriert sind.
Das vorliegende Dokument gilt auch für Außengeräte, die allein für den Gebrauch mit dem Gerät bestimmt sind.
Dieses Dokument gilt nicht für:
implantierte Oxygenatoren;
Flüssigkeits-Oxygenatoren;
extrakorporale Kreisläufe (Blutschlauchsysteme);
separate Wärmeaustauscher;
separate Hilfsgeräte und
separate arterielle Filterleitungen.
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels (oxygénateurs) (ISO 7199:2016)
L'ISO 7199:2016 précise les prescriptions relatives aux échangeurs gaz/sang extracorporels stériles (oxygénateurs), à usage unique, destinés à oxygéner le sang des patients et à en éliminer le dioxyde de carbone.
L'ISO 7199:2016 s'applique également aux échangeurs thermiques et aux filtres artériels qui font partie intégrante des oxygénateurs.
Il s'applique aussi à l'équipement externe propre à l'utilisation de l'oxygénateur.
L'ISO 7199:2016 ne s'applique pas aux:
- oxygénateurs implantés,
- oxygénateurs liquides,
- circuits extracorporels (tubulures pour le sang),
- échangeurs thermiques non intégrés,
- dispositifs annexes distincts, et
- filtres de ligne artérielle distincts.
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov (oksigenatorji) (ISO 7199:2016)
Ta dokument določa zahteve za sterilne zunajtelesne izmenjevalnike krvnih plinov za enkratno uporabo, ki so namenjeni za dovajanje kisika in odvajanje ogljikovega dioksida iz človeške krvi.
Ta dokument se uporablja tudi za izmenjevalnike toplote in arterijske filtre, ki so sestavni deli
oksigenatorja.
Ta dokument se uporablja tudi za zunanjo opremo, edinstveno za uporabo oksigenatorja.
Ta dokument se ne uporablja za
– vsajene oksigenatorje,
– tekoče oksigenatorje,
– zunajtelesne obtoke (cevke za kri),
– ločene izmenjevalnike toplote,
– ločene pomožne pripomočke in
– ločene arterijske filtre.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2017
1DGRPHãþD
SIST EN ISO 7199:2014
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(oksigenatorji) (ISO 7199:2016)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO
7199:2016)
Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren)
(ISO 7199:2016)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels
(oxygénateurs) (ISO 7199:2016)
Ta slovenski standard je istoveten z: EN ISO 7199:2017
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 7199
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2017
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 7199:2014
English Version
Cardiovascular implants and artificial organs - Blood-gas
exchangers (oxygenators) (ISO 7199:2016)
Implants cardiovasculaires et organes artificiels - Kardiovaskuläre Implantate und künstliche Organe -
Échangeurs gaz/sang extracorporels (oxygénateurs) Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016)
(ISO 7199:2016)
This European Standard was approved by CEN on 6 November 2016.
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, 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 7199:2017 E
worldwide for CEN national Members.
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
European foreword
This document (EN ISO 7199:2017) has been prepared by Technical Committee ISO/TC 150 “Implants
for surgery” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
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 2017, 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 7199:2014.
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.
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.
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 — Correlations between undated normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of
EN ISO
the ISO standard
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 and
Amd 1:2006
ISO 10993-7 EN ISO 10993-7:2008 and ISO 10993-7:2008 and
EN ISO 10993-7:2008/AC:2009 ISO 10993-7:1/Cor 1:2009
ISO 10993-11 EN ISO 10993-11:2009 ISO 10993-11:2006
ISO 11135 EN ISO 11135:2014 ISO 11135:2014
ISO 11137-1 EN ISO 11137-1:2006 and ISO 11137-1:2006 and
EN ISO 11137-1:2006/A1:2013 Amd 1:2013
ISO 11607-1 EN ISO 11607-1:2009 and ISO 11607-1:2006 and
EN ISO 11607-1:2009/A1:2014 Amd 1:2014
ISO 11607-2 EN ISO 11607-2:2006 and ISO 11607-2:2006 and
EN ISO 11607-2:2006/A1:2014 Amd 1:2014
ISO 15675 — ISO 15675:2009
ISO 17665-1 EN ISO 17665-1:2006 ISO 17665-1:2006
Endorsement notice
The text of ISO 7199:2016 has been approved by CEN as EN ISO 7199:2017 without any modification.
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 a 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 that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made,
the risk management process needs to be in compliance with Directive 93/42/EEC as amended by
2007/47/EC. This means that risks have to be reduced "as far as possible", "to a minimum", "to the
lowest possible level", "minimized" or "removed", according to the wording of the corresponding
essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements
Clause(s)/sub-clause(s) of
(ERs) of Directive Remarks/Notes
this EN
93/42/EEC
7.2 4.1.1; 4.1.2; 5.2; 5.2.1; 5.2.2; 4.1.1 and 4.1.2 address
5.3; 5.3.1; 5.3.1.1; 5.3.1.2; manufacturers’ requirements
5.3.2; 5.3.2.1; 5.3.2.2; 6.2.1 d); to ensure product sterility,
6.2.2 d); 6.3 u) 1) non-pyrogenicity, and
biocompatibility. 5.2 and 5.3
with associated sub-clauses
address testing for the above
to verify compliance that
products are sterile, non-
pyrogenic, and biocompatible.
6.2.1, 6.2.2 and 6.3 with
associated sub-clauses
address labelling to include
the manufacturers’
documentation attesting to
the above, which are to be
supplied on the unit
container, shipping container,
and accompanying product
literature, including
«Instructions for Use».
7.3 4.3.6; 4.3.6.1; 4.3.6.2; 5.2; 4.3.6 with associated sub-
5.2.1; 5.2.2; 5.4.3; 5.4.3.1; clauses address blood cell
5.4.3.2 damage when the product is
used for its intended purpose.
5.2 with associated sub-
clauses address biological
characteristics and
manufacturers’ compliance
for verification regarding
sterility, non-pyrogenicity and
biocompatibility. 5.4.3 with
associated sub-clauses
describe specific testing
parameters for documenting
blood cell damage.
The second part of ER 7.3
relating to medicinal products
is not covered.
7.5 4.2.1; 4.2.2; 4.2.4 4.2.1 and 4.2.2 address
minimizing the risk of leakage
by the requirement that blood
pathways (e.g. oxygenator,
heat exchanger) do not leak.
4.2.4 addresses the
requirement that connectors
used for connections to the
blood pathways must be
secure, which also addresses
the minimization of risk of
leakage.
Only the first sentence of ER
7.5 is covered.
8.1 4.1.1; 4.1.2; 6.2.1 d); 6.2.2 d); 4.1.1 and 4.1.2 require
6.3 u) 1) products to be sterile, non-
pyrogenetic, and
biocompatible. 6.2.1, 6.2.2,
and 6.3 with associated sub-
clauses address sterilization
information to be supplied on
labelling for the units,
shipping containers, and in
the accompanying
«Instructions for Use».
Only the first sentence of ER
8.1 is covered.
9.1 4.2.4 4.2.4 addresses
manufacturers‘ requirements
that connectors provide for
secure connection of
additional products for
assembly into a system for its
intended use.
4.2.4 covers ER 9.1 in respect
of blood pathway connections
only.
13.1 6.1 a); 6.2.1 a) h); 6.2.2 a); 6.3 6.1, 6.2 and 6.3 with
a) associated sub-clauses
address the manufacturers’
identification, «Instructions
for Use» for the safe use of the
product and any special
handling or storage
conditions.
13.1, first paragraph, last five
words only are covered by 6.1
a), 6.2.1 a), 6.2.2 a) and 6.3 a)
only.
13.2 6.2.1 g) i) Clause 6.2.1 with associated
sub-clauses address use of
approved symbols on the unit
container.
13.2 is covered only is respect
of 'Read Instructions for use'
and 'Single use only'.
13.3 a) 6.2.1 a), 6.2.2 a) and 6.3 a) The standard does not
address a requirement
regarding an authorised
representative when the
manufacturer does not have a
registered place of business in
the Community.
ER 13.3 a) is covered by 6.2.1
a), 6.2.2 a) and 6.3 a) but only
in respect of manufacturer.
13.3 b) 6.2.1 b)-c); 6.2.2 b)-c); 6.3 b) 6.2.1, 6.2.2 and 6.3 with
associated sub-clauses
address identification of the
device and contents of the
packaging.
13.3 c) 6.2.1 d); 6.2.2 d) 6.2.1 and 6.2.2 with
associated sub-clauses
address designation of the
sterility of the product on the
unit and shipping containers
and in the «Instructions for
Use».
13.3 d) 6.2.1 f) 6.2.1 with the associated sub-
clause address product batch,
lot or serial number
designations.
ER 13.3 d) is only met if the
batch code is preceded by the
word 'LOT'.
13.3 e) 6.2.2 e) 6.2.2 with the associated sub-
clause address expiry date on
the unit container.
ER 13.3 e) is only met if the
expiry date is given as a year
and month.
13.3 f) 6.2.1 i) 6.2.1 with the associated sub-
clause address one-time
(single) use of the device.
13.3 i) 6.2.1 h); 6.2.2 f) 6.2.1 and 6.2.2 with
associated sub-clauses
address labelling on the unit
and shipping containers
regarding any special
handling or storage
conditions.
13.3 j) 6.3 d) 6.3 and 6.4 with associated
sub-clauses address special or
unique procedures and
limitations during use in
accompanying documents.
ER 13.3 j) is covered by 6.3 d)
only in respect of the
„Instructions for Use».
13.3 k) 6.2.1 g) 6.2.1 with the associated sub-
clause address «Instructions
for Use» containing warnings
and precautions.
ER 13.3 k) is covered by 6.2.1
g) only in respect of the unit
container.
13.4 6.2.1 g); 6.3 6.2.1 with the associated sub-
clause and 6.3 address
«Instructions for Use»
labelling on the unit container
and in accompanying
documents supplied with the
product.
13.6 c) 6.3 e)-g) 6.3 with associated sub-
clauses address mounting and
connection of device
components for safe use.
ER 13.6 c) is covered only to
the extent shown in 6.3 e)-g).
13.6 i) 6.3 e) f) The standard addresses
sterile products that do not
require further treatment
before use. 6.3 with
associated sub-clauses
address mounting of the
device and assembly with
other products before use.
ER 13.6 i) is covered only to
the extent shown in 6.3 e)-f).
13.6 p) 4.2.3 4.2.3 addresses testing of
volumetric measurements
and tolerances specified by
the manufacturer.
ER 13.6 p)
...
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