Foreword

Introduction

1Scope

2Normative references

3Terms and definitions

4Requirements

4.1Biological safety and haemocompatibility

4.2Sterility

4.3Non-pyrogenicity

4.4Mechanical characteristics

4.4.1Structural integrity

4.4.2Blood compartment integrity

4.4.3Connectors

4.4.3.1Plasmafilter blood compartment connectors

4.4.3.2Plasmafilter filtrate compartment connectors

4.5Performance characteristics

4.5.1Plasma filtration rate

4.5.2Sieving coefficient

4.5.3Blood compartment volume

4.5.4Blood compartment pressure drop

4.5.5Haemolytic characteristics

4.6Expiry date

5Test methods

5.1General

5.2Biological safety and haemocompatibility

5.3Sterility

5.4Non-pyrogenicity

5.5Mechanical characteristics

5.5.1Structural integrity

5.5.1.1General

5.5.1.2Positive pressure test

5.5.1.3Negative pressure test

5.5.2Blood compartment integrity

5.5.3Connectors

5.5.3.1General

5.5.3.2Plasmafilter blood compartment connectors

5.5.3.3Plasmafilter plasma filtrate compartment connectors

5.6Performance characteristics

5.6.1Test solution

5.6.2Plasma filtration rate — Test procedure

5.6.3Sieving coefficient

5.6.3.1Test solution

5.6.3.2Test procedure

5.6.3.3Calculation of the sieving coefficient

5.6.4Blood compartment volume

5.6.5Blood compartment pressure drop

5.6.5.1General

5.6.5.2Test solution

5.6.5.3Test procedure

5.6.6Haemolytic characteristics

5.6.6.1General

5.6.6.2Test solution

5.6.6.3Test procedure

5.6.6.4Expression of haemolysis rate

5.7Expiry date

6Labelling

6.1Labelling on the device

6.2Labelling on unit containers

6.3Labelling on the outer containers

6.4Information to be given in the accompanying documentation

7Packaging

Bibliography