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).

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

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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. The numbering of the parts follows in parallel the clinical applications listed in ISO 80369‑1:2018 where applicable. Other parts are expected to be added in the future for applications not yet covered.

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 a smaller type;
— compliance checks: italic type;
— Terms defined in this document or as noted: small capitals.

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.

For the purposes of this document, the following verbal forms are used:

— “shall” indicates that compliance with a requirement or a test is mandatory for compliance with this document,
— “should” indicates 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.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

BS ISO 18250-1:2018

Medical devices. Connectors for reservoir delivery systems for healthcare applications - General requirements and common test methods

Current, Under Review

Published:

31 Dec 2018