ISO 13960:2003

Cardiovascular implants and artificial organs — Plasmafilters

ISO 13960:2003 specifies requirements for sterile, single-use plasmafilters, intended for use on humans. ISO 13960:2003 is not applicable to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices. ISO 13960:2003 does not address the replacement fluid.

Implants cardio-vasculaires et organes artificiels — Filtres de plasma

General Information

• Status: Withdrawn
• Publication Date: 02-Dec-2003
• Withdrawal Date: 02-Dec-2003
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 28-Jun-2010

Relations

• Revised: ISO 13960:2010 - Cardiovascular implants and extracorporeal systems — Plasmafilters
• Effective Date: 04-Feb-2009

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13960
First edition
2003-12-01
Cardiovascular implants and artificial
organs — Plasmafilters
Implants cardio-vasculaires et organes artificiels — Filtres de plasma

Reference number
ISO 13960:2003(E)
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ISO 13960:2003(E)
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ISO 13960:2003(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Biological characteristics . 2
4.2 Physical characteristics . 2
4.3 Performance characteristics . 3
5 Test methods . 4
5.1 General . 4
5.2 Methods for assessment of biological characteristics . 4
5.3 Methods for assessment of physical characteristics . 4
5.4 Performance characteristics . 5
6 Packaging . 7
7 Information to be provided by the manufacturer . 7
7.1 Information to be placed on the plasmafilter . 7
7.2 Information to be given in the accompanying documents . 7
Bibliography . 9
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ISO 13960:2003(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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13960 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants.
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ISO 13960:2003(E)
Introduction
This International Standard contains requirements and acceptance criteria (including test methods) for safety-
related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been
included. Non-specific requirements are covered by references to other International Standards, listed in the
Normative references clause. This International Standard does not address matters related to toxicity. Such
issues are covered in the relevant part of ISO 10993. The reader is advised to review the normative references.
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INTERNATIONAL STANDARD ISO 13960:2003(E)
Cardiovascular implants and artificial organs — Plasmafilters
1Scope
This International Standard specifies requirements for sterile, single-use plasmafilters, intended for use on
humans.
This International Standard is not applicable to the extracorporeal circuits used for plasmapheresis or other
extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters,
haemoperfusion devices, vascular access devices, oxygenators or active medical devices.
This International Standard does not address the replacement fluid.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 8637, Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
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 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 13488, Quality systems — Medical devices — Particular requirements for the application of ISO 9002
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blood compartment
part of a plasmafilter through which blood is intended to pass
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ISO 13960:2003(E)
3.2
filtration rate
rate at which fluid is removed from the blood compartment across the semi-permeable membrane into the
filtrate compartment of a plasmafilter
3.3
plasmapheresis
plasma separation
separation of a portion of the whole plasma from formed elements of blood by means of a semi-permeable
membrane
NOTE Plasmapheresis can also be accomplished through the use of differential centrifugation, but this method is not
addressed in this International Standard.
3.4
plasmafilter
device intended to perform membrane plasmapheresis
3.5
transmembrane pressure
p
TM
the mean pressure across the semipermeable membrane
p +p
inlet outlet
p = −p
TM filtrate
2
3.6
sieving coefficient
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in blood
4 Requirements
4.1 Biological characteristics
4.1.1 Biocompatibility
Parts of plasmafilters that will come into direct or indirect contact with blood during their intended clinical use
shall be biocompatible with respect to their intended clinical use.
Compliance shall be verified in accordance with 5.2.1.
4.1.2 Sterility and non-pyrogenicity
Blood and filtrate compartments shall be sterile and non-pyrogenic.
Compliance shall be verified in accordance with 5.2.2.
4.2 Physical characteristics
4.2.1 Structural integrity
When tested in accordance with 5.3.1, plasmafilters shall not leak.
NOTE This requirement refers to the external integrity of the devices.
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ISO 13960:2003(E)
4.2.2 Blood compartment integrity
When tested in accordance with 5.3.2, plasmafilters shall not leak.
4.2.3 Connectors and ports
4.2.3.1 Connections to the blood compartment
Except when plasmafilters and the extracorporeal circuits are designed as an integral system, the dimensions
of the blood inlet and outlet connectors of plasmafilters shall be in accordance with ISO 8637.
Compliance shall be verified by inspection.
4.2.3.2 Connection to the filtrate compartment
Except when plasmafilters and their extracorporeal circuits are designed as an integral system, the filtrate ports
shall be male 6% (Luer) taper lock fittings with dimensions in acco
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