ISO 8536-4:2019 医療用輸液装置—パート4：使い捨て用輸液セット、重力供給 | ページ 2

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.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.

This sixth edition cancels and replaces the fifth edition (ISO 8536-4:2010), which has been technically revised. It also incorporates the Amendment ISO 8536-4:2010/Amd.1:2013.

The main changes compared to the previous edition are as follows:

• Clause 5 'Designation' now refers to Clause 10 'Labelling';
• the physical requirements – especially regarding stand-alone air-inlet devices – have been further clarified;
• Clause 10 'Labelling' has been updated;
• test for leakage in A.3 has been updated;
• determination of flow rate in A.5 has been totally reviewed;
• normative references in Clause 2 and the Bibliography have been updated.

A list of all parts in the ISO 8536 series can be found on the ISO website.

1 Scope

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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.

3 Terms and definitions

No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography