ISO 15142-1:2003 PDF

Name: ISO 15142-1:2003 — Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails
SKU: ISO 15142-1:2003
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Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails

Название (английский):

ISO 15142-1:2003

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
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 15142-1:2003 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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 15142-1:2003 - "Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails" defines terms and minimum requirements for metal intramedullary nails used for the temporary intramedullary stabilization of long bones. The standard applies to metal intramedullary fixation devices implanted surgically in the human body and is part of the ISO 15142 series for metal intramedullary nailing systems.

Key topics and technical requirements

Scope and terminology: Precise definitions for nail types (solid, cannulated, closed-section, open-section, angulated, curved, straight, bundle nails), connection elements, locking components, insertion/removal devices, and dimensional terms such as inner/outer diameter, effective and overall length.

Materials: Metallic materials must comply with ISO 14602 and the relevant parts of ISO 5832 (implants for surgery - metallic materials).

Surface requirements: Surface finish shall not adversely affect biocompatibility; surface effects on bone ongrowth and device removal must be addressed in the device risk analysis.

Marking and labelling: Implants must be marked according to ISO 14630; orientation (left/right) and unique markings to prevent positioning errors are required. Product labels must include, at minimum, nail-specific data such as length and diameter.

Design for insertion/removal: Nail geometry must reflect insertion/removal technique. Slots and connection features must accept hooks and extractor devices (see ISO 15142-3). Standard threads should follow ISO 965-1/2 metric dimensions; Annex A lists common ANSI B1.1 thread designations used in existing nails (e.g., 1/4-28, 5/16-24).

Compatibility: Connection elements, locking components (screws, bolts, cross-arms) and insertion devices must be compatible with the nail’s design and documented dimensions.

Applications and who uses it

ISO 15142-1 is intended for:

Medical device manufacturers designing and producing intramedullary nails and fixation systems

Regulatory and quality teams assessing conformity and preparing technical documentation

R&D and design engineers specifying materials, surface treatments, and connection features

Hospitals and procurement teams evaluating device compatibility and labelling

Clinical engineers and orthopedic surgeons who require standardized definitions and interface dimensions for instrumentation and implants

Practical use: ensures consistent terminology, material selection guidance, labelling, and mechanical interface standards to improve device safety, interchangeability, and ease of removal.

Related standards

ISO 15142-2: Locking components (related part of the series)

ISO 15142-3: Connection devices and reamer diameter measurements

ISO 14602, ISO 14630 (implant general and particular requirements)

ISO 5832 (metallic implant materials)

ISO 965-1 / ISO 965-2 (metric screw thread tolerances)

ANSI B1.1 (informative thread designations referenced in Annex A)

Keywords: ISO 15142-1, intramedullary nails, metal intramedullary nailing systems, implants for surgery, intramedullary fixation, medical device standard.

ISO 15142-1:2003 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

BS ISO 15142-3:2003

Implants for surgery. Metal intramedullary nailing systems. Connection devices and reamer diameter measuremen…

BS EN ISO 14602:2011

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

ISO 5832-11:2024

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

SIST EN ISO 14630:2025

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

ISO 965-1:2013/Amd 1:2021

ISO general purpose metric screw threads — Tolerances — Part 1: Principles and basic data — Amendment 1

ISO 15142-2:2003

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