Cardiovascular implants and extracorporeal systems — Plasmafilters

ISO 13960:2010 specifies requirements for sterile, single use plasmafilters, intended for use on humans.

Implants cardiovasculaires et systèmes extracorporels — Filtres pour plasma

General Information

Status
Withdrawn
Publication Date
27-Jun-2010
Withdrawal Date
27-Jun-2010
Current Stage
9599 - Withdrawal of International Standard
Start Date
17-Jul-2018
Completion Date
17-Jul-2018
Ref Project

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INTERNATIONAL ISO
STANDARD 13960
Second edition
2010-07-01
Cardiovascular implants and
extracorporeal systems — Plasmafilters
Implants cardiovasculaires et systèmes extracorporels — Filtres pour
plasma
Reference number
ISO 13960:2010(E)
ISO 2010
---------------------- Page: 1 ----------------------
ISO 13960:2010(E)
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© ISO 2010

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ii © ISO 2010 – All rights reserved
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ISO 13960:2010(E)
Contents Page

Foreword ............................................................................................................................................................iv

Introduction.........................................................................................................................................................v

1 Scope......................................................................................................................................................1

2 Normative references............................................................................................................................1

3 Terms and definitions ...........................................................................................................................1

4 Requirements.........................................................................................................................................2

4.1 Biological characteristics.....................................................................................................................2

4.2 Physical characteristics........................................................................................................................3

4.3 Performance characteristics ................................................................................................................3

5 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 Information provided by the manufacturer.........................................................................................7

6.1 Information to be placed on the plasmafilter......................................................................................7

6.2 Information to be given in the accompanying documents ...............................................................7

6.3 Information to be given, as applicable, in a prominent form in the accompanying

documents .............................................................................................................................................8

Bibliography........................................................................................................................................................9

© ISO 2010 – All rights reserved iii
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ISO 13960:2010(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 and extracorporeal systems.

This second edition cancels and replaces the first edition (ISO 13960:2003), which has been technically

revised.
iv © ISO 2010 – All rights reserved
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ISO 13960:2010(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

Clause 2. This International Standard does not cover matters related to toxicity. Such issues are covered in

relevant parts of ISO 10993.
© ISO 2010 – All rights reserved v
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INTERNATIONAL STANDARD ISO 13960:2010(E)
Cardiovascular implants and extracorporeal systems —
Plasmafilters
1 Scope

This International Standard specifies requirements for sterile, single-use plasmafilters, intended for use on

humans.

This International Standard does not apply 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 within a risk

management process

ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

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 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for the

development, validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2010 – All rights reserved 1
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ISO 13960:2010(E)
3.1
blood compartment
part of plasmafilter through which blood is intended to pass
3.2
filtrate compartment
part of plasmafilter through which filtrate flows
3.3
filtration rate

rate at which fluid is removed from the blood compartment across the semipermeable membrane into the

filtrate compartment of a plasmafilter
3.4
plasmapheresis
plasma separation

separation of a portion of the whole plasma from formed elements of blood by means of a semipermeable

membrane

NOTE Plasmapheresis can also be accomplished through the use of differential centrifugation but this method is not

covered by this International Standard.
3.5
plasmafilter
device intended to perform membrane plasmapheresis
3.6
transmembrane pressure
TMP
mean pressure across the semipermeable membrane
NOTE The transmembrane pressure is given by the following equation:
pp+
BI BO
pp=−
TM f
where
p is the pressure at blood compartment inlet;
p is the pressure at blood compartment outlet;
p is the pressure at filtrate compartment outlet.
3.7
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.
2 © ISO 2010 – All rights reserved
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ISO 13960:2010(E)
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.
4.2.2 Blood compartment integrity
When tested in accordance with 5.3.2, the blood compartment 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 in

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