ISO 15674:2001
(Main)Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
Implants cardiovasculaires et organes artificiels — Systèmes réservoirs de cardiotomie/veineux à paroi dure (avec/sans filtre) et sacs réservoirs veineux mous
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 15674
First edition
2001-11-01
Cardiovascular implants and artificial
organs — Hard-shell cardiotomy/venous
reservoir systems (with/without filter) and
soft venous reservoir bags
Implants cardiovasculaires et organes artificiels — Systèmes réservoirs de
cardiotomie/veineux à paroi dure (avec/sans filtre) et sacs réservoirs
veineux mous
Reference number
ISO 15674:2001(E)
© ISO 2001
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ISO 15674:2001(E)
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ISO 15674:2001(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological characteristics . 3
4.2 Physical characteristics . 3
4.3 Performance characteristics . 3
5 Tests and measurements to determine compliance with this International Standard . 4
5.1 General . 4
5.2 Biological characteristics . 5
5.3 Physical characteristics . 5
6 Information supplied by the manufacturer . 5
6.1 Information to be given on the reservoir (labelling) . 5
6.2 Information to be given on the packaging . 6
6.3 Information to be given in the accompanying documents . 6
6.4 Information to be given in the accompanying documents in a prominent form . 7
7 Packaging . 7
Annex
A Factors to be considered in evaluating performance characteristics . 8
Bibliography. 9
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ISO 15674:2001(E)
Foreword
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 15674 was prepared by Technical Committee ISO/TC 150, Implants for surgery,
Subcommittee SC 2, Cardiovascular implants.
Annex A of this International Standard is for information only.
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INTERNATIONAL STANDARD ISO 15674:2001(E)
Cardiovascular implants and artificial organs — Hard-shell
cardiotomy/venous reservoir systems (with/without filter) and soft
venous reservoir bags
1 Scope
This International Standard specifies requirements for sterile, single-use, extracorporeal hard-shell
cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during
cardiopulmonary bypass (CPB) surgery.
This International Standard applies only to the blood reservoir aspects for multifunctional systems which may have
integral components such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing.
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals.
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity.
ISO 11134, Sterilization of health care products — Requirements for validation and routine control — Industrial moist
heat sterilization.
ISO 11135, Medical devices — Validation and routine control of ethylene oxide sterilization.
ISO 11137, Sterilization of health care products — Requirements for validation and routine control — Radiation
sterilization.
ISO 11607, Packaging for terminally sterilized medical devices.
ISO 13485, Quality systems — Medical devices — Particular requirements for the application of ISO 9001.
ISO 13488, Quality systems — Medical devices — Particular requirements for the application of ISO 9002.
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent
and the development, validation and routine control of a sterilization process for medical devices.
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ISO 15674:2001(E)
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
hard-shell cardiotomy reservoir
extracorporeal device consisting of rigid walls designed to collect, defoam and filter suctioned blood
3.2
hard-shell venous reservoir
extracorporeal device consisting of rigid walls designed to collect and defoam venous blood
3.3
soft-bag venous reservoir
extracorporeal device consisting of collapsible, pliable walls designed to collect venous blood
3.4
hard-shell cardiotomy/venous reservoir system
extracorporeal device designed to function simultaneously as both a venous reservoir and cardiotomy reservoir
3.5
blood-gas exchanger
oxygenator
extracorporeal device designed to supplement, or be a substitute for, the respiratory function of the lung
3.6
blood
�referring to a fluid used in testing� heparinized human or bovine blood, whole or diluted with physiological saline
solution
3.7
integral part
part that is connected to the reservoir or is part of the reservoir system and that cannot normally be separated by the
user
3.8
operating variable
setting of controls which affects the function of the device
3.9
hold-up volume
volume present in the device during passage of fluid through the device
NOTE This volume may vary with the flow rate and other factors.
3.10
break-through volume
volume of fluid that, when added during the initial priming of the dry device (as received from the manufacturer), must
be exceeded before fluid first exits the device
3.11
sealed hard-shell reservoir
hard-shell reservoir that may be operated at either positive or negative pressure
3.12
priming volume
volume of fluid required to fill the filter
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ISO 15674:2001(E)
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
The blood pathway shall be sterile and non-pyrogenic.
Compliance shall be verified in accordance with 5.2.1.
4.1.2 Biocompatibility
Parts of the blood pathway shall be biocompatible with respect to their intended use.
Compliance shall be
...
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