ISO 8637-2:2018 血液浄化のための体外システム—パート2：血液透析器、血液透析フィルター、および血液フィルターのための体外血液回路 | 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. 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.

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This document was prepared by Technical committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.

This first edition of ISO 8637-2:2018 cancels and replaces the third edition (ISO 8638:2010), which has been technically revised. The following changes have been made:

• Figure 1, Figure 2, and Figure 3 have been revised.

A list of all the parts in the ISO 8637 series can be found on the ISO website.

Introduction

This document is concerned with the extracorporeal blood circuit manufactured for single use and intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements specified in this document for the extracorporeal blood circuit will help to ensure safety and satisfactory function.

It was not found practicable to specify materials of construction. This document therefore requires only that materials have been tested and that the methods and results are made available upon request.

The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been revised and specified to ensure compatibility with these devices, as specified in ISO 8637-1. The design and dimensions have been selected in order to minimize the risk of leakage of blood and ingress of air. Connectors with either fixed or loose locking shells are permitted.

This document reflects the consensus of physicians, manufacturers and other interested parties for devices that are approved for clinical use.

1 Scope

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.

This document does not apply to:

• haemodialysers, haemodiafilters or haemofilters;
• plasmafilters;
• haemoperfusion devices;
• vascular access devices;
• blood pumps;
• pressure monitors for the extracorporeal blood circuit;
• air detection devices;
• systems to prepare, maintain or monitor dialysis fluid;
• systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

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 following terms and definitions apply.

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

Bibliography