ISO/IEEE 11073-10404:2010 健康情報学—パーソナルヘルスデバイス通信—パート10404：デバイスの専門化—パルスオキシメータ | 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.

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The main task of technical committees is to prepare International Standards. Draft International Standards adopted 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 called to the possibility that implementation of this standard may require the use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or scope of patents or patent claims or determining whether any licensing terms or conditions provided in connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards Association.

ISO/IEEE 11073-10404 was prepared by the 11073 Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE Std 11073-10404-2008). It was adopted by Technical Committee ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO and IEEE. Both parties are responsible for the maintenance of this document.

ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health device communication (text in parentheses gives a variant of subtitle):

• Part 10101: (Point-of-care medical device communication) Nomenclature
• Part 10201: Domain information model
• Part 10404: Device specialization — Pulse oximeter
• Part 10407: Device specialization — Blood pressure monitor
• Part 10408: (Point-of-care medical device communication) Device specialization — Thermometer
• Part 10415: (Point-of-care medical device communication) Device specialization — Weighing scale
• Part 10417: Device specialization — Glucose meter
• Part 10471: (Point-of-care medical device communication) Device specialization — Independant living activity hub
• Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
• Part 20601: (Point-of-care medical device communication) Application profile — Optimized exchange protocol
• Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
• Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless

Introduction

ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This standard uses the optimized framework created in IEEE Std 11073-20601™-2008^a and describes a specific, interoperable communication approach for pulse oximeters. These standards align with, and draw upon, the existing clinically focused standards to provide support for communication of data from clinical or personal health devices.

2 Normative references

The following referenced documents are indispensable for the application of this document (i.e., they must be understood and used, so that each referenced document is cited in text and its relationship to this document is explained). For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments or corrigenda) applies.

IEEE Std 11073-20601-2008, Health informatics-Personal health device communication-Part 20601: Application profile-Optimized Exchange Profile. ⁴

See Annex A for all informative material referenced by this standard.

Annex A

Bibliography