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Document type: International StandardDocument subtype: AmendmentDocument stage: (40) EnquiryDocument language: E

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ISO/TC 76 /SC

Date: 2011-03-09

ISO 8536-4:2010/DAM 1

ISO/TC 76/SC /WG 1

Secretariat: DIN

Infusion equipment for medical use — Part 4: Infusion sets for singleuse, gravity feed

Matériel de perfusion à usage médical — Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité

Warning

This document is not an ISO International Standard. It is distributed for review and comment. It is subject tochange without notice and may not be referred to as an International Standard.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.

7/27/2019 ISO_TC_76___SC_N_813


ISO 8536-4:2010/DAM 1

ii © ISO 2011 – All rights reserved

Copyright notice

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ISO 8536-4:2010/DAM 1

© ISO 2011 – All rights reserved iii

Contents Page

Foreword ............................................................................................................................................................iv 1 Modification of 9.1 .................................................................................................................................1 2 Modification of 9.2 .................................................................................................................................1 3 Addition of a new section 11 on disposal ...........................................................................................1 4 Modification of A.2 ................................................................................................................................1 5 Modification of title of Figure A.1 ........................................................................................................2 6 Modification of A.6 ................................................................................................................................2 7 Modification of Bibliography................................................................................................................2

7/27/2019 ISO_TC_76___SC_N_813


ISO 8536-4:2010/DAM 1

iv © ISO 2011 – All rights reserved

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 ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with theInternational 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 Standardsadopted 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 patentrights. ISO shall not be held responsible for identifying any or all such patent rights.

Amendment 1 to ISO 8536-4:2010 was prepared by Technical Committee ISO/TC 76, Transfusion, infusionand injection, and blood processing equipment for medical and pharmaceutical use, and by TechnicalCommittee CEN/TC 205, Non-active medical devices in collaboration.

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DRAFT AMENDMENT ISO 8536-4:2010/DAM 1

© ISO 2011 – All rights reserved 1

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

1 Modification of 9.1

In alignment with ISO 1135-4:2010, 8.1, the following change respectively amendment shall be introduced:

⎯ the note between e) and f) becomes a numbering as "NOTE 1";

⎯ at the end of 9.1 add:

"NOTE 2 The presence of substances of interest can be indicated by using symbol 2725 of ISO 7000by replacing the "XXX" by the abbreviation of the substance. The absence of substances of interest canbe indicated by crossing the respective symbol."

2 Modification of 9.2

In alignment with ISO 1135-4:2010, 8.2, the following amendment shall be added at the end of 9.2:

"NOTE The presence of substances of interest can be indicated by using symbol 2725 of ISO 7000

by replacing the "XXX" by the abbreviation of the substance. The absence of substances of interest canbe indicated by crossing the respective symbol."

3 Addition of a new section 11 on disposal

In alignment with ISO 1135-4:2010, clause 10, add the following new clause:

"11 Disposal

Information for a secure and environmentally sound disposal of single-use infusion sets should be given,e.g. "Always dispose of blood contaminated products in a manner consistent with established biohazardprocedures."

4 Modification of A.2

The whole clause A.2 shall be amended as follows:

"A.2 Tests for leakage

A.2.1 In the beginning of the test, the whole system shall be tempered at the test temperature.

A.2.2 Connect the infusion set with air supply and close all other openings. Apply air with an internal

excess pressure of 50 kPa to the infusion set for 15 s. Inspect the infusion set for any leakage of air under

water at 40 °C."

A.2.3 will be deleted because this test is not relevant for gravity sets.

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ISO 8536-4:2010/DAM 1

2 © ISO 2011 – All rights reserved

5 Modification of title of Figure A.1

To clarify that the test apparatus according Figure A.1 is just an example the Figure title shall be changed to:

"Figure A.1 — Example apparatus setup for testing the efficiency of the fluid filter "

6 Modification of A.6

The second sentence of A.6 shall be amended as follows:

"Fill the infusion set with water in such a manner that no air bubbles are trapped and apply a pressure of 20 kPa above the atmospheric air pressure."

7 Modification of Bibliography

In alignment with ISO 1135-4:2010, Bibliography, and the modifications of 9.1 and 9.2 (see above) thereferenced ISO 7000 in the Bibliography shall be added between the enumerations [1] and [2] as newenumeration [2] as follows:

[2] ISO 7000, Graphical symbols for use on equipment — Index and synopsis

All following enumerations have to be renumbered.

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