ISO 15142-2:2003 PDF

Name: ISO 15142-2:2003 — Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components
SKU: ISO 15142-2:2003
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Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components

Название (английский):

ISO 15142-2:2003

Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 3
Дата публикации:: 12 августа 2003 г.
Издание:: ISO IS 15142 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

ISO 15142-2:2003 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

BS EN ISO 14602:2011

Non-active surgical implants. Implants for osteosynthesis. Particular requirements.

SIST EN ISO 14630:2025

Non-active surgical implants - General requirements (ISO 14630:2024)

ISO 83:1976

Steel — Charpy impact test (U-notch)

ISO 5835-4:1983

Implants for surgery — Metal bone screws — Dimensions — Part 4: Screws with symmetrical thread, conical under…

ISO 15142-1:2003

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