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//ISO 14602:2010

ISO 14602:2010

Name: ISO 14602:2010 — Non-active surgical implants — Implants for osteosynthesis — Particular requirements
SKU: ISO 14602:2010
Price: 25 EUR
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Non-active surgical implants — Implants for osteosynthesis — Particular requirements

Название (английский):

ISO 14602:2010

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 12 апреля 2010 г.
Издание:: ISO IS 14602 edition 2 version 1
ICS:: 11.040.40

Тип поставки:

Full version25 €Ask AI2 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:1 рабочий день

Цена:25 €

Описание (английский):

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants. In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

Abstract

Overview

- - is a Level‑2 ISO standard that supplements the general requirements of . It specifies particular requirements for non‑active surgical implants used in osteosynthesis (orthopaedic fixation), addressing intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and the information supplied by the manufacturer.

Key topics and requirements

Intended performance: Define intended purpose (e.g., fracture treatment, spinal stabilization, arthrodesis, bone lengthening, tendon/ligament reconstruction) and typical anatomical sites.
Functional characteristics: Describe fixation type, anchorage, component linkage, removability, and action on bone and adjacent tissues (stabilization, compression/distraction, alignment control).
Design attributes: Requirements for interconnecting systems, dimensional tolerances, anatomical sizing, ergonomics and measures to reduce use error during implantation.
Materials: Material selection consistent with ISO 14630 and Annex C (informative list of materials with proven clinical use).
Design evaluation:
- Pre‑clinical: in‑vitro handling tests, cadaveric evaluation where required, static/dynamic mechanical testing, validated modelling and biomechanical simulations.
- Clinical evaluation and post‑market surveillance in line with ISO 14630.
- Annex D lists relevant testing and design‑evaluation standards.
Manufacturing, sterilization and packaging: Specific controls to preserve device integrity and sterility through distribution.
Information supplied: Labelling, instructions for use, restrictions on combinations and implant marking requirements.

Practical applications and users

ISO 14602 is directly applicable to:

Medical device manufacturers designing and producing orthopaedic and spinal fixation implants.
Design and R&D engineers specifying materials, tolerances and biomechanical testing.
Quality assurance and regulatory teams preparing technical documentation and conformity evidence.
Notified bodies and regulatory assessors reviewing device compliance and clinical evidence.
Clinical researchers and hospitals evaluating implant performance and post‑market data.

Typical use cases include device development for fracture fixation plates, screws, rods, spinal constructs and other osteosynthesis systems, and preparing pre‑clinical test plans, clinical evaluations and labelling.

Related standards

ISO 14630 - General requirements for non‑active surgical implants (to be applied together).
ISO/TR 14283 - Fundamental principles correspondence.
Annexes in ISO 14602 list level‑3 standards, material standards and testing standards helpful for specific implant types.

Keywords: ISO 14602, implants for osteosynthesis, non‑active surgical implants, orthopedic implants standard, design evaluation, implant materials, sterilization, medical device regulatory compliance.