SIST EN ISO 7199:2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
This document 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.
This document also applies to heat exchangers and arterial filters that are integral parts of the
oxygenator.
This document also applies to external equipment unique to the use of the oxygenator.
This document 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.
11.040.40 - Implants for surgery, prosthetics and orthotics
VAZ - Healthcare
2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
EN ISO 7199:2017 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
SIST EN ISO 7199:2014 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
Amended By
SIST EN ISO 7199:2017/A1:2020 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
01-april-2017
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)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels
(oxygénateurs) (ISO 7199:2016)
Ta slovenski standard je istoveten z: EN ISO 7199:2017
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 7199:2017 en
ICS 11.040.40 Supersedes EN ISO 7199:2014
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)
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
© 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.
EN ISO 7199:2017 (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
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.
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
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
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,
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-
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
EN ISO 11137-1:2006/A1:2013 Amd 1:2013
ISO 15675 — ISO 15675:2009
The text of ISO 7199:2016 has been approved by CEN as EN ISO 7199:2017 without any modification.
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
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]
Clause(s)/sub-clause(s) of
(ERs) of Directive Remarks/Notes
this EN
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
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
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
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
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
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
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)
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
address identification of the
device and contents of the
13.3 c) 6.2.1 d); 6.2.2 d) 6.2.1 and 6.2.2 with
address designation of the
sterility of the product on the
unit and shipping containers
and in the «Instructions for
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
address labelling on the unit
and shipping containers
regarding any special
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
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
13.4 6.2.1 g); 6.3 6.2.1 with the associated sub-
clause and 6.3 address
labelling on the unit container
and in accompanying
documents supplied with the
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
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) is only covered for
blood volumes only and only
when the degree of accuracy
is given in the "Instructions
for Use».
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
INTERNATIONAL ISO
STANDARD 7199
Cardiovascular implants and artificial
organs — Blood-gas exchangers
(oxygenators)
Implants cardiovasculaires et organes artificiels — Échangeurs gaz/
sang extracorporels (oxygénateurs)
ISO 7199:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of
the requester.
ISO copyright office
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copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 2
4 Requirements .......................................................................................................................................................................................................... 3
4.1 Biological characteristics ............................................................................................................................................................... 3
4.1.1 Sterility and non-pyrogenicity ............................................................................................................................. 3
4.1.2 Biocompatibility ............................................................................................................................................................... 3
4.2 Physical characteristics ................................................................................................................................................................... 4
4.2.1 Blood pathway integrity ............................................................................................................................................ 4
4.2.2 Heat exchanger fluid pathway integrity ....................................................................................................... 4
4.2.3 Blood volumes .................................................................................................................................................................... 4
4.2.4 Connectors ............................................................................................................................................................................ 4
4.3 Performance characteristics........................................................................................................................................................ 4
4.3.1 Oxygen and carbon dioxide transfer rates ................................................................................................. 4
4.3.2 Heat exchanger performance factor ................................................................................................................ 4
4.3.3 Integral arterial filtration efficiency................................................................................................................ 4
4.3.4 Integral arterial filter flow rate capacity ..................................................................................................... 4
4.3.5 Integral arterial filter air handling capability ......................................................................................... 4
4.3.6 Blood cell damage ........................................................................................................................................................... 5
4.3.7 Time-dependent performance changes ....................................................................................................... 5
4.3.8 Shelf life ................................................................................................................................................................................... 5
5 Tests and measurements to determine compliance with this document ..................................................5
5.1 General ........................................................................................................................................................................................................... 5
5.3.2 Heat exchanger water pathway integrity.................................................................................................... 6
5.4.5 Filtration efficiency ........................................................................................................................................... ............. 9
5.4.6 Integral arterial filter flow rate ........................................................................................................................... 9
5.4.7 Air-handling capability of integral arterial filter.................................................................................. 9
6 Information supplied by the manufacturer ..........................................................................................................................10
6.1 Information on the oxygenator ..............................................................................................................................................10
6.2 Information on the packaging .................................................................................................................................................11
6.2.1 Unit container ..................................................................................................................................................................11
6.2.2 Shipping container ......................................................................................................................................................11
6.3 Information in the accompanying documents ..........................................................................................................11
6.4 Information in the accompanying documents in a prominent form .....................................................12
7 Packaging ..................................................................................................................................................................................................................12
Bibliography .............................................................................................................................................................................................................................13
© ISO 2016 – All rights reserved iii
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the World Trade Organization (WTO)
principles in the Technical Barriers to Trade (TBT), see the following URL: http://www.iso.org/iso/
foreword.html
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 7199:2009), which has been technically
revised.
It also incorporates the Amendment ISO 7199:2009/Amd.1:2012.
iv © ISO 2016 – All rights reserved
This document is intended to ensure that devices designed to affect the exchange of gases in support
of, or as a substitution for, the normal respiratory function of the lungs have been adequately tested
for both their safety and function, and that extracorporeal device characteristics are appropriately
disclosed when labelling the device.
This document therefore contains procedures to be used for evaluation of extracorporeal blood-
gas exchangers (oxygenators). Type test procedures for determination of the gas transfer, blood cell
damage and heat exchanger performance are described, although limits for these characteristics are
not specified. Ready identification of the performance characteristics should, however, assist the user
in the selection of an oxygenator that will suit the needs of the patient.
This document also includes minimum reporting requirements, which will allow the user to compare
performance characteristics of oxygenators of different designs in a standard way.
This document makes reference to other International Standards in which methods for determination
of characteristics common to medical devices can be found.
No provisions have been made for quantification of microbubble generation or for non-formed elements
of bovine blood because there currently is no consensus regarding satisfactorily reproducible test
Requirements for animal and clinical studies have not been included in this document. Such studies
may be parts of a manufacturer's quality system.
This document contains only those requirements that are specific to oxygenators. Non-spec
SIST EN ISO 5840-3:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
EN ISO 5840-3:2021
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
This document is applicable to heart valve substitutes intended for implantation and provides general
requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the
accessory devices, packaging, and labelling required for their implantation and for determining the
appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve
substitute through risk management. The selection of appropriate qualification tests and methods
are derived from the risk assessment. The tests can include those to assess the physical, chemical,
biological, and mechanical properties of heart valve substitutes and of their materials and components.
The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished
heart valve substitute.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves
(e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in
circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from
human tissue that is rendered non-viable.
NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
This document is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for
examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and
to the accessory devices, packaging, and labelling required for their implantation and for determining
the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a
surgical heart valve substitute through risk management. The selection of appropriate qualification
tests and methods are derived from the risk assessment. The tests can include those to assess the
physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of
their materials and components. The tests can also include those for pre-clinical in vivo evaluation and
clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve
substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and
ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are
based on the results of the risk analysis.
SIST EN ISO 25539-2:2020(Main)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
EN ISO 25539-2:2020
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery
systems) and requirements with respect to nomenclature, design attributes and information supplied
by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro
test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies
general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to
the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not
always available. As further scientific and clinical data become available, appropriate revision of this document
will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular
scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of
the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent
systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this
document, comprehensive requirements and testing are not described for these uses. Similarly, specific
stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and
testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion,
including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated
endovascular prosthesis), are within the scope of this document, but test methods are not described for
the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical
evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the
scope of this document. Stents covered with materials that significantly modify the permeability of the
uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The
stent design or intended use might dictate the need to address functional requirements identified in
both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses,
stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides
requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with
vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular
stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow
diverters are within the scope of this document, but comprehensive requirements and testing are not
described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive
with respect to the drug-eluting properties of these devices.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1.
Although absorbable stents and stents with absorbable coatings are within the scope of this document,
this document is not comprehensive with respect to the absorbable properties of these devices.
NOTE 3 Absorbable implants are within the scope of ISO/TS 17137.
Although coated stents and coated stent systems are within the scope of this document, this document
is not comprehensive with respect to coatings.
NOTE 4 Some coating properties are within the scope of ISO 17327-1.
This document does not address the requirements for, and the evaluation of, viable tissues and nonviable
biologic materials used in the construction of vascular stents.
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
EN-ISO 8637-1 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans. This document does not apply to: - extracorporeal blood circuits; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; - reprocessing procedures and equipment.
SIST EN ISO 7199:2017/A1:2020(Amendment)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
EN ISO 7199:2017/A1:2020
DOW = DAV + 36 months
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel-chromium-molybdenum alloy for use in the manufacture of surgical implants.
NOTE - The mechanical properties of a Sample obtained from a finished product made of this alloy may not necessarily
comply with the specifications given in this part of ISO 5832.
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
ISO 5832-1:2016 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.
NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
ISO 5832-7:2016 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
SIST EN ISO 16054:2019(Main)
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
This document defines minimum data sets for implants to facilitate recording and international
exchange of data for the purposes of implant tracking systems. This data can also be used to support
retrieval analysis and implant registry.
This document is applicable to the manufacturers and distributors of medical devices intended
for implant via a surgical procedure and to those hospitals and other medical facilities which carry
out implant or explant procedures. It specifies requirements for data items to be recorded by the
manufacturers and distributors of implants and by hospitals and other medical facilities at both the
time of implant event and at the time of any subsequent explant event.
This document is intended to define a minimum data set to be recorded for all implant and explant
events, as well as providing for the timely retrieval of minimum implant data related to specific subsets
of patients who have received specific identified devices or devices within a specified range of lot, batch
or serial codes, for the purpose of patient follow up.
It is not the intent of this document to provide a means of data recovery which is related to specific
medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or
product recall in the event of unforeseen device malfunction.