ISO 15142-3:2003 手術用インプラント—金属髄内釘システム—パート3：接続装置とリーマー直径の測定 | 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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, 2.

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 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.

ISO 15142-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices.

ISO 15142 consists of the following parts, under the general title Implants for surgery — Metal intramedullary nailing systems:

• Part 1: Intramedullary nails
• Part 2: Locking components
• Part 3: Connection devices and reamer diameter measurements

Introduction

Intramedullary nailing is a method of fixation for temporary stabilization of long bones with reduced strength due to fractures or disease or both. Medical and engineering considerations influence the design of the different devices and the choice of a device for a particular clinical situation.

Nails are often, but not always, removed when they have completed their intended purpose of temporary stabilization.

1 Scope

This part of ISO 15142 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving other requirements and dimensions for the devices used to insert, remove or both insert and remove intramedullary nails. It also provides a means of measuring reamer diameter. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except drive connections for locking elements.

2 Normative references

The following referenced documents are indispensable for the application 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.

Bibliography