SIST EN ISO 13356:2015 PDF

Name: SIST EN ISO 13356:2015 — Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
SKU: SIST EN ISO 13356:2015
Price: 73.76 EUR
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Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

Название (английский):

SIST EN ISO 13356:2015

Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 21
Дата публикации:: 3 ноября 2015 г.
ICS:: 11.040.40
Технический комитет:: VAZ - Healthcare

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Описание (английский):

ISO 13356:2015 specifies the requirements and corresponding test methods for a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 13356:2015 - Implants for surgery - Ceramic materials based on yttria‑stabilized tetragonal zirconia (Y‑TZP) - specifies requirements and corresponding test methods for biocompatible, biostable Y‑TZP used as a bone‑substitute material for surgical implants. Endorsed by CEN, this international standard defines how to characterize the physical, chemical and mechanical properties of yttria‑stabilized tetragonal zirconia to support safe implant design, manufacturing and regulatory compliance.

Key Topics

The standard focuses on material performance and laboratory test methods rather than clinical procedures. Major technical topics and requirements include:

Material scope: Properties required of yttria‑stabilized tetragonal zirconia (Y‑TZP) intended for implant use.

Physical and chemical characterization: Bulk density and chemical composition verification.

Microstructure assessment: Grain size, phase analysis including amount of monoclinic phase and microstructural reporting.

Mechanical testing: Methods for strength and reliability testing such as:

Biaxial flexural strength
Four‑point bending strength
Weibull modulus (statistical strength distribution)
Young’s modulus and hardness
Cyclic fatigue testing

Safety and long‑term stability: Accelerated aging tests and radioactivity measurements to assess biostability and safety.

Test reporting and traceability: Defined procedures for specimen preparation, apparatus, results calculation and standardized test reports.

Applications

EN ISO 13356:2015 is practical for anyone responsible for ensuring the safety and performance of ceramic implants:

Implant manufacturers - material selection, incoming inspection, process control and product documentation.

Material and mechanical test laboratories - implementing standardized test methods and issuing reports accepted by regulators and customers.

Design engineers - understanding mechanical and aging behaviors of Y‑TZP when specifying components for dental, orthopedic and craniofacial implants.

Quality and regulatory teams - demonstrating conformity to recognized test methods during CE marking, regulatory submissions or supplier qualification.

Researchers and materials scientists - comparing Y‑TZP formulations and processing effects using standardized metrics.

Relevant SEO keywords: EN ISO 13356:2015, Y‑TZP, yttria‑stabilized tetragonal zirconia, ceramic implants, biocompatible ceramics, implant materials standard, surgical implant testing.

Related Standards (if applicable)

Normative references cited in EN ISO 13356:2015 include (among others):

ISO 13383‑1 (microstructural characterization)

ISO 14704 (flexural strength of monolithic ceramics)

ISO 14705 (hardness testing)

ISO 3310‑1, ISO 3611, ISO 7500‑1 Consult the standard text for the full list of normative references and detailed test procedures.

SIST EN ISO 13356:2015 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards (if applicable)

Технические детали

ISO 13356:2015

Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

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