ISO 21534:2007

Name: ISO 21534:2007 — Non-active surgical implants — Joint replacement implants — Particular requirements
SKU: ISO 21534:2007
Price: 25 EUR
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Non-active surgical implants — Joint replacement implants — Particular requirements

Название (английский):

ISO 21534:2007

Non-active surgical implants — Joint replacement implants — Particular requirements

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 26 сентября 2007 г.
Издание:: ISO IS 21534 edition 2 version 1
ICS:: 11.040.40

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Описание (английский):

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview - ISO 21534:2007 (Joint replacement implants)

ISO 21534:2007 is an International Standard that specifies particular requirements for non‑active surgical implants in the family of joint replacement implants. It covers total and partial joint replacement implants, artificial ligaments (and their fixation devices), and bone cement. The standard defines requirements for intended performance, design attributes, materials, design evaluation (preclinical and clinical), manufacturing, sterilization, packaging and the information to be supplied by the manufacturer.

Keywords: ISO 21534:2007, joint replacement implants, non-active surgical implants, artificial ligaments, bone cement, UHMWPE.

Key topics and technical requirements

Scope and definitions

Applies to implants intended to provide function similar to a natural joint and connected to bones.
Artificial ligaments and associated fixing devices are treated as implants.

Intended performance

Design inputs must address expected loads, angular movement range, dynamic response, wear, sizing for the intended population and coating durability.

Design attributes

Stability while permitting required motion, avoidance of tissue abrasion, creep resistance (important for ligaments) and wear control.

Materials

Materials selection requirements (see informative Annexes for acceptable materials).
Guidance on dissimilar metals/alloys and permitted combinations.

Surface finish and sphericity

Metal/ceramic articulating on UHMWPE: Ra ≤ 0.1 µm (total joint replacements).
Partial implants (metal/ceramic): Ra ≤ 0.5 µm.
Convex spherically-conforming components on UHMWPE: Ra ≤ 0.05 µm and radial separation ≤ 10 µm.
Concave spherically-conforming UHMWPE components: Ra ≤ 2 µm and radial separation ≤ 200 µm.

Design evaluation and testing

Preclinical (bench) testing, clinical investigations and post‑market surveillance are required elements.

Manufacture, sterilization, packaging and labelling

Requirements for production controls, metal/plastic/ceramic surface inspection, sterilization methods and expiration, packaging and manufacturer-supplied information (including orientation/side‑specific labelling).

Practical applications and who uses it

ISO 21534:2007 is used by:

Medical device manufacturers developing hip, knee or partial joint implants, artificial ligaments and bone cements - for design controls, material selection and production specifications.

Regulatory and quality teams creating technical files and conformity evidence for market access.

Test laboratories and R&D groups conducting wear, fatigue and surface-finish testing.

Clinical teams and procurement specialists seeking device specifications and manufacturer information for safe implant selection.

Related standards

ISO 14630 - Non-active surgical implants: general requirements (level 1).

Wear and endurance/testing standards: ISO 14242-1/2, ISO 14243 series, ISO 7206-4/8, ISO 14879-1.

Clinical investigation guidance: ISO 14155-1.

Use ISO 21534:2007 in combination with applicable level‑3 (type‑specific) standards for comprehensive compliance and device safety.

ISO 21534:2007

Abstract

Похожие стандарты

Overview - ISO 21534:2007 (Joint replacement implants)

Key topics and technical requirements

Practical applications and who uses it

Related standards

Технические детали

BS EN ISO 14630:2024

Non-active surgical implants. General requirements.

ISO 14242-1:2014

Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for w…

BS ISO 14243-5:2019

Implants for surgery. Wear of total knee prostheses. Durability performance of the patellofemoral joint.

BS ISO 14879-1:2020

Implants for surgery. Total kneejoint prostheses. Determination of endurance properties of knee tibial trays.