ISO 15675:2001
(Main)Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters
Implants cardiovasculaires et organes artificiels — Systèmes de pontage cardio-pulmonaire — Filtres sanguins pour la ligne artérielle
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 15675
First edition
2001-10-01
Cardiovascular implants and artificial
organs — Cardiopulmonary bypass
systems — Arterial line blood filters
Implants cardiovasculaires et organes artificiels — Systèmes de pontage
cardio-pulmonaire — Filtres sanguins pour la ligne artérielle
Reference number
ISO 15675:2001(E)
© ISO 2001
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ISO 15675:2001(E)
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ISO 15675:2001(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 Biological characteristics . 2
4.2 Physical characteristics . 3
4.3 Performance characteristics . 3
5 Tests and measurements to determine compliance with this International Standard . 3
5.1 General . 3
5.2 Biological characteristics . 4
5.3 Physical characteristics . 4
5.4 Performance characteristics . 4
6 Information supplied by the manufacturer . 6
6.1 Information to be given on the arterial filter . 6
6.2 Information to be given on the packaging . 6
6.3 Information to be given in the accompanying documents . 7
6.4 Information to be given in accompanying documents in a prominent form . 8
7 Packaging . 8
Bibliography. 9
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ISO 15675:2001(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 com-
mittees. 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 liai-
son 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 15675 was prepared by Technical Committee ISO/TC 150, Implants for surgery,
Subcommittee SC 2, Cardiovascular implants.
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INTERNATIONAL STANDARD ISO 15675:2001(E)
Cardiovascular implants and artificial organs — Cardiopulmonary
bypass systems — Arterial line blood filters
1 Scope
This International Standard specifies requirements for sterile, single-use, arterial filters intended to filter and remove
emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans dur-
ing cardiopulmonary bypass surgery.
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 publica-
tions do not apply. However, parties to agreements based on this International Standard are encouraged to investi-
gate 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 reg-
isters of currently valid International Standards.
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2:
Lock fittings
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 ster-
ilization
ISO 11607, Packaging for terminally sterilized medical devices
ISO 13485:1996, Quality systems — Medical devices — Particular requirements for the application of ISO 9001
ISO 13488:1996, 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 15675:2001(E)
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
arterial line blood filter
accessory device used as part of the cardiopulmonary bypass system in the arterial blood return line for filtering
particles such as blood clots, debris and gas emboli from the blood
3.2
blood pathway
paths of the arterial filter containing blood during its intended clinical use
3.3
blood
heparinized human or bovine blood, whole or diluted with physiological saline solution
3.4
blood cell damage
loss or destruction of cellular components of the blood components
3.5
platelet percentage reduction
percentage reduction of platelets contained in a circuit incorporating an arterial line blood filter, less the percentage
reduction in an identical control circuit without an arterial line blood filter, as a function of time
3.6
plasma-free haemoglobin generation
difference between the concentration of plasma-free haemoglobin in a circuit incorporating an arterial blood filter and
the concentration in an identical control circuit without an arterial blood filter, as a function of time
3.7
white blood cell percentage reduction
percentage reduction of white blood cells contained in a circuit incorporating an arterial line blood filter, less the
percentage reduction in an identical control circuit without an arterial line blood filter, as a function of time
3.8
filtration efficiency
ability of the filter to remove particles from the simulated blood suspension test fluid, expressed as a percentage
3.9
blood analogue
test solution which simulates blood viscosity
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and nonpyrogenicity
The blood pathway shall be sterile and nonpyrogenic. 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 verified in
accordance with 5.2.2.
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ISO 15675:2001(E)
4.2 Physical characteristics
4.2.1 Blood pathway integrity
When tested in accordance with 5.3.1, the blood pathway shall not leak.
4.2.2 Blood volume
The volume of the blood pathway shall be within the tolerance spec
...
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