ISO 15142-2:2003
(Main)Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
ISO 15142-2:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving requirements for the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails.
Implants chirurgicaux — Systèmes d'enclouage intramédullaire en métal — Partie 2: Éléments de fixation
General Information
- Status
- Published
- Publication Date
- 11-Aug-2003
- 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
- Start Date
- 04-May-2022
- Completion Date
- 13-Dec-2025
Overview
ISO 15142-2:2003 - "Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components" specifies requirements and classification for metallic locking components used with intramedullary nails for temporary stabilization of long bones. The standard applies to all metal intramedullary fixation devices used for temporary fixation in the human body, excluding non-lockable (unlockable) nails. It focuses on the locking elements (screws, bolts, wires, expanding elements, claws, etc.) that control relative motion between nail and bone.
Key topics and technical requirements
- Scope and classification
- Defines what constitutes a locking component and classifies components as bolts/screws, wires, expanding elements, or other (claws, hooks).
- Materials and biocompatibility
- Locking components should be manufactured from the same material as the nail, or else biocompatibility must be demonstrated per ISO 10993.
- A risk assessment per ISO 14971 is required to address corrosion and other hazards; galvanic corrosion effects must be considered if different metals are used.
- Surface requirements
- Surface finish must not adversely affect biocompatibility and should be assessed in the device risk analysis (see ISO 14602). Surface selection often aims to avoid bone ongrowth that could impede removal.
- Marking and labelling
- Implants must be marked per ISO 14630; orientation (left/right) must have unique markings to prevent misplacement.
- Package labelling must include minimum data (e.g., length, diameter) following ISO 14602; material composition should be stated when compatibility with specific nail metallurgy is required.
- Drive connections
- Screw/bolt locking components are to be inserted/removed with screwdrivers per ISO 8319, using recesses in accordance with ISO 5835. The standard acknowledges compatibility with established ASTM drive/recess designs.
Applications and users
- Medical device manufacturers designing metal intramedullary nails and locking components will use ISO 15142-2 to ensure product consistency, safety, and regulatory readiness.
- Design engineers and R&D teams for orthopedic implants to guide material selection, surface treatment, and mechanical interfaces.
- Regulatory affairs and quality managers for compliance, labelling, and risk management (ISO 14971).
- Test laboratories and certification bodies validating biocompatibility, mechanical fit, and drive interfaces.
- Hospitals and procurement teams referencing standards when specifying implant systems for fracture fixation and temporary long-bone stabilization.
Related standards
- ISO 15142-1 (Intramedullary nails) and ISO 15142-3 (Connection devices and reamer diameter measurements)
- ISO 10993 (Biological evaluation), ISO 14971 (Risk management), ISO 14602 / ISO 14630 (Implant requirements and labelling)
- ISO 5835 (Bone screw dimensions), ISO 8319 (Drive connections)
- ASTM F116 / ASTM F543 (common alternative drive and screw specifications)
ISO 15142-2:2003 is essential for anyone involved in the design, manufacture, testing, and clinical use of metal intramedullary nailing systems and their locking components.
Frequently Asked Questions
ISO 15142-2:2003 is a standard published by the International Organization for Standardization (ISO). Its full title is "Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components". This standard covers: ISO 15142-2:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving requirements for the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails.
ISO 15142-2:2003 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving requirements for the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails.
ISO 15142-2:2003 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 15142-2
First edition
2003-08-01
Implants for surgery — Metal
intramedullary nailing systems —
Part 2:
Locking components
Implants chirurgicaux — Systèmes d'enclouage intramédullaire en
métal —
Partie 2: Éléments de fixation
Reference number
©
ISO 2003
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ii © ISO 2003 — All rights reserved
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Classification and designation . 1
5 Materials. 2
6 Surface requirements. 2
7 Marking. 2
8 Product labelling. 2
9 Drive connections for insertion and removal of locking components. 2
Bibliography . 3
Foreword
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(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
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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 15142-2 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: Intr
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