ISO 15142-1:2003

Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails

ISO 15142-1:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, defining terms and giving requirements for intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body.

Implants chirurgicaux — Systèmes d'enclouage intramédullaire en métal — Partie 1: Clous intramédullaires

General Information

• Status: Published
• Publication Date: 11-Aug-2003
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Drafting Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 04-May-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 15142-1
First edition
2003-08-01


Implants for surgery — Metal
intramedullary nailing systems —
Part 1:
Intramedullary nails
Implants chirurgicaux — Systèmes d'enclouage intramédullaire en
métal —
Partie 1: Clous intramédullaires




Reference number
ISO 15142-1:2003(E)
©
ISO 2003

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ISO 15142-1:2003(E)
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ii © ISO 2003 — All rights reserved

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ISO 15142-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Materials. 4
5 Surface requirements. 4
6 Marking. 4
7 Product label. 4
8 Design requirements for insertion and removal. 4
Annex A (informative) ANSI B1.1 threads . 8
Bibliography . 9

© ISO 2003 — All rights reserved iii

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ISO 15142-1:2003(E)
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, Part 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 15142-1 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

iv © ISO 2003 — All rights reserved

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ISO 15142-1:2003(E)
Introduction
Intramedullary nailing is a method of fixation for temporary stabilization of long bones with reduced strength
due to fractures or disease or both. Because of the wide variety of the devices, some illustrations are provided
in this part of ISO 15142. 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.


© ISO 2003 — All rights reserved v

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INTERNATIONAL STANDARD ISO 15142-1:2003(E)

Implants for surgery — Metal intramedullary nailing systems —
Part 1:
Intramedullary nails
1 Scope
This part of ISO 15142 specifies metallic medical devices used for the temporary intramedullary stabilization
of long bones by surgical implantation, defining terms and giving requirements for intramedullary nails. It is
applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human
body.
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.
ISO 965-1, ISO general-purpose metric screw threads — Tolerances — Part 1: Principles and basic data
ISO 965-2, ISO general purpose metric screw threads — Tolerances — Part 2: Limits of sizes for general
purpose external and internal screw threads — Medium quality
ISO 5832 (all parts), Implants for surgery — Metallic materials
ISO 14602, Non-active surgical implants — Implants for osteosynthesis — Particular requirements
ISO 14630, Non-active surgical implants — General requirements
ISO 15142-3, Implants for surgery — Metal intramedullary nailing systems — Part 3: Connection devices and
reamer diameter measurements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. See Figures 1 to 4 for examples
of various intram
...