ISO 18250-7:2018 医療機器—ヘルスケアアプリケーション用のリザーバーデリバリーシステム用コネクタ—パート7：血管内注入用コネクタ | 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. 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. www.iso.org/patents

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.

A list of all the parts in the ISO 18250 series can be found on the ISO website.

In this document, the following print types are used:

• Requirements and definitions: roman type.
• Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in smaller type.
• Terms defined in standard or as noted: small capitals.
• Compliance requirements: italic type.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:

• “shall” means that compliance with a requirement or a test is mandatory for compliance with this document,
• “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document, and
• “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

Introduction

During the development of the standard for enteral small-bore connectors (ISO 80369-3), it became clear that the risk of misconnections was not limited to the patient access connectors and that the whole enteral system needed to be considered. The possible misconnection between enteral feed reservoir access connectors and the spikes typically used on intravenous administration sets was also reviewed. However, as feed reservoirconnectors are not exactly within the definition of small-bore connectors, it was decided to develop a separate standard (ISO 18250-3) for these connectors, taking into account the risks of misconnections with other devices such as intravenous (IV) bags.

During the development of ISO 18250-3, it became apparent that the ubiquitous intravenous spike was specified in various ISO medical device standards but that the geometry and materials requirements for the female port on the intravenous reservoir were not defined. However, the performance of this female port was defined in various ISO standards.

This document, therefore, specifies the design, dimensions and materials for the female port. It makes reference to existing performance standards. It also includes tests to validate that the spike and the female port do not interconnect with the other reservoir connectors of the ISO 18250 series.

This document also includes analysis sufficient to include traditional Luerconnectors of ISO 80369-7 as permissible reservoir connectors for intravascular applications.

This document is not a device standard as it specifies only the requirements of the interfaces for connectors used in intravascular reservoirs and intravascular infusion sets.

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

For the purposes of this document, the terms and definitions given in ISO 18250-1 and the following apply.

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

Bibliography