EN ISO 14602:2011 PDF

Name: EN ISO 14602:2011 — Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
SKU: EN ISO 14602:2011
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Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

Название (английский):

EN ISO 14602:2011

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 23
Дата публикации:: 19 октября 2011 г.
Издание:: CEN EN 14602 edition 2 version 1
ICS:: 11.040.40

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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

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 14602:2011 (identical to ISO 14602:2010) is a Level‑2 international standard that defines particular requirements for non‑active surgical implants for osteosynthesis. It complements the general requirements in ISO 14630 and provides detailed guidance on the design, materials, evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer for implants used to stabilize bone (osteosynthesis) in trauma or corrective surgery.

Key topics and technical requirements

This standard focuses on practical, safety‑related aspects of osteosynthesis implants, including:

Intended performance and purpose

Clear definition of functional characteristics and intended conditions of use for the implant.

Design attributes

Design considerations that affect mechanical performance, biocompatibility and implant retrieval or in‑situ use.

Materials

Selection of materials with proven clinical performance; Annex C lists ISO material standards considered acceptable through clinical use.

Design evaluation

Pre‑clinical and clinical evaluation requirements and ongoing post‑market surveillance to monitor long‑term performance.

Manufacturing

Process controls and traceability to ensure consistent product quality.

Sterilization and packaging

Requirements for validated sterilization methods and packaging that maintains sterile barrier integrity until use.

Information and labelling

Instructions for use, labelling, restrictions on combinations with other devices, and implant markings (including special purpose markings).

Standards cross‑references

Annexes B and D list Level‑3 and related ISO standards for specific implant types, testing and design evaluation.

Practical applications and who uses this standard

EN ISO 14602:2011 is used by:

Medical device manufacturers designing, producing or marketing osteosynthesis implants (plates, screws, rods, pins).

Regulatory and quality assurance teams preparing technical files, conformity assessments and demonstrating compliance with medical device directives/regulations.

Clinical engineers and surgical instrument designers ensuring compatibility between implants and instrumentation.

Testing laboratories conducting pre‑clinical mechanical, biocompatibility and sterilization validation tests.

Notified bodies and regulators assessing conformity to Essential Requirements (see Annex ZA for relationship to EU Directive 93/42/EEC).

Related standards

ISO 14630 (general requirements for non‑active surgical implants)

ISO/TR 14283 (fundamental principles correspondence)

Level‑3 ISO standards for specific implant types and test methods (refer to Annexes B–D of ISO 14602)

Keywords: EN ISO 14602:2011, ISO 14602:2010, osteosynthesis implants, non‑active surgical implants, medical device standards, sterilization, design evaluation, materials, post‑market surveillance.

EN ISO 14602:2011 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses this standard

Related standards

Технические детали

ISO 14602:2010

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

SIST EN ISO 14630:2025

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

ISO/TR 14283:1995

Implants for surgery — Fundamental principles

BS EN ISO 14602:2011

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