Transfusion equipment for medical use - Part 3: Blood-taking set

Transfusion equipment for medical use - Part 3: Blood-taking set

Mat&iel de transfusion 2 usage mbdical - Partie 3: Nkessaires pour pr&vemen t sanguin

First edition - 1986-11-01

UDC 615.473 : 615.38 Ref. No. lSO~ll35/3-1986 (E)

Descriptors : medical equipment, blood transfusion equipment, specifications, tests, packing, marking.

Price based on 8 pages

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national Standards bodies (ISO member bedies). The work of preparing International Standards is normally carried out through ISO technical committees. Esch 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, govern- mental and non-governmental, in liaison with ISO, also take part in the work.

Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the ISO Council. They are approved in accordance with ISO procedures requiring at least 75 % approval by the member bodies voting.

International Standard ISO 1135/3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection eguipment for medical use.

ISO 1135/3 is a revision, in Part, of ISO 11354977.

Users should note that all International Standards undergo revision from time to time and that any reference made herein to any other International Standard implies its latest edition, unless othetwise stated.

0 International Organkation for Standardkation, 1986 Printed in Switzerland

ii

Contents

Page

Scope and field of application ... 1

References...- ... 1

General requirements ... 1

Materials ... 3

Physical requirements. ... 3

Chemical requirements. ... 3

Biological requirements ... 4

Marking and labelling ... 4

Packaging ... 5

Annexes A

Test for integrity ... 6

B

Chemical tests on the extract ... 6

C Biological tests ... 8

This page intentionally lef’t blank

1 Scope and field of application

This part of ISO 1135 specifies requirements for types of blood- taking sets for medical use in Order to ensure functional inter- changeability of transfusion equipment.

The materials and the components of the sets are validated by various test methods (type tests) and, in addition, tests are per- formed for the release of lots of finished sets (lot tests).

The manufacturer shall select appropriate test methods to com- ply with the requirements laid down in this part of ISO 1135.

Secondary aims of this part of ISO 1135 are to provide a) specifications relating to the quality and Performance of materials used in transfusion equipment ;

b) a unified presentation of terms and designations for such equipment.

In some countries, the national pharmacopoeia or other na- tional regulations are legally binding and

take

precedence over this part of ISO 1135.

This part of ISO 1135 specifies requirements applicable to sterilized blood-taking sets intended for Single use and for a Single donor only.

2 References

ISO 1773, Laboratory glassware - Boilng flasks (narrow- necked).

ISO 3696, Water for laboratory use - Specifications and test methods. 1)

ISO 7864, Sterile hypodermic needles for Single use. .

nents

consist of the blood-taking assembly

~ly, which may be separate or com-

3 General requirer

3.1 Types of sets

The blood-taking set shall and the air-outlet assemb bined.

A diaqram of a typical blood-taking set is illustrated in the figure:

3.2 Blood-taking assembly

The blood-taking assembly shall consist of a needle for vein puncture (the blood-taking needle) and of a needle (the bottle needle) to be inserted through one of the specified areas pro- vided on the bottle closure. Esch needle is connected to one end of a length of tubing.

3.3 Air-outlet assembly

The air-outlet assembly shall consist of an air filter housing with air filter combined with a needle (the air-outlet needle) for pierc- ing the specified area provided on the bottle closure.

The filter shall be capable of preventing microbial ingress.

3.4 Sterilization

The set shall be sterile in its unit Container. Evidente of the ef- fectiveness of the sterilization process used shall be provided.

1) At present at the staqe of draft.

ISOll36/3-1986 (EI

0

¹ Protective cap

0

² Bottle needle

0

^{3 Tubing}

0

⁴ Flow regulator 1)

0

⁷ Air filter

0

⁸ Air filter housing

0

⁹ Air-outlet needle

0

¹⁰ Protective cap

0

⁵ Blood-ta king needle

0

⁶ Protective cap

a) Blood-taking assembly b1 Air-outlet assembly

NOTE - The figure illustrates an example of the configuration of a typical blood-taking set but it does not ferm part of the requirements for blood- taking sets as laid down in this part of ISO 1135.

Figure - Blood-taking set

1) Optional

2