ISO 80369-20:2015 ヘルスケアアプリケーションにおける液体および気体用の小口径コネクタ—パート20：一般的な試験方法 | 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, 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, 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 ).

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 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 .

The committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.

ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and gases in healthcare applications

• Part 1: General requirements
• Part 3: Connectors for enteral applications
• Part 5: Connectors for limb cuff inflation applications
• Part 6: Connectors for neuraxial applications
• Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
• Part 20: Common test methods

The following parts are under preparation:

• Part 2: Connectors for breathing systems and driving gases applications

An additional part on Connectors for urethral and urinary applications is planned.

Introduction

In this part of ISO 80369, 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 a smaller type;
• terms defined in ISO 80369-1 and Clause 3: small capitals.

In this part of ISO 80369, 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 International Standard conform to usage described in ISO/IEC Directives, 2, Annex H. For the purposes of this part of ISO 80369, the auxiliary verb

• “shall” means that compliance with a requirement or a test is mandatory for compliance with this part of ISO 80369,
• “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this part of ISO 80369, 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.

The following paragraph is directed to authorities with jurisdiction and is not intended to address clinical implementation.

The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations might need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than three years from the date of publication for equipment newly designed and not earlier than five years from the date of publication for equipment already in production.

This part of ISO 80369 describes the common test methods for evaluating the performance requirements of the small-bore connectors specified in this series.

During the development of the ISO 80369- series, it became evident that many of the test methods were very similar for each of the applications. It was therefore decided to standardize all the test methods into a separate part of the series to prevent unnecessary duplication and minor differences. It is also recognized that not all connectors can be evaluated using each test method in this part. The test methods applicable to each connector are specified in the respective part of the ISO 80369- series.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 80369-1:2010, ISO 14971:2007, and the following apply.

Bibliography