iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 13356:2015

(Main)

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

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

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.

Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkoniumoxid (Y-TZP) (ISO 13356:2015)

Diese Internationale Norm legt die Anforderungen und dazugehörigen Prüfverfahren für ein biokompatibles und biostabiles keramisches Knochenersatzmaterial auf der Grundlage von yttriumstabi-lisiertem tetragonalem Zirkoniumoxid (yttria tetragonal zirconia polycristal, Y TZP) fest, das als Material für chirurgische Implantate verwendet wird.

Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisée à l'yttrium (Y-TZP) (ISO 13356:2015)

L'ISO 13356:2015 spécifie les exigences et les méthodes d'essai correspondantes applicables aux matériaux de substitution osseuse, biocompatibles et biostables, à base de zircone tétragonale stabilisée à l'oxyde d'yttrium (polycristaux de zircone tétragonale stabilisée à l'yttrium, Y-TZP), utilisés en tant que matériaux constitutifs d'implants chirurgicaux.

Vsadki (implantati) za kirurgijo - Keramični materiali na osnovi tetragonalnega cirkonija, stabiliziranega z itrijem (Y-TZP) (ISO 13356:2015)

Ta mednarodni standard določa zahteve biozdružljivega in biostabilnega keramičnega materiala za kostne nadomestke na osnovi tetragonalnega cirkonija, stabiliziranega z itrijem, (z itrijem stabilizirani polikristal tetragonalnega cirkonija, Y-TZP) za uporabo kot material za kirurške vsadke ter ustrezne preskusne metode zanj.

General Information

Status
Published
Publication Date
29-Sep-2015
Withdrawal Date
30-Mar-2016
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55 - Dentistry
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Sep-2015
Completion Date
30-Sep-2015
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
SIST EN ISO 13356:2015 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

Relations

Replaces
EN ISO 13356:2013 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008)
Effective Date
08-Jun-2022

Buy Standard

EN ISO 13356:2015EN ISO 13356:2015
PreviousNext
Standard
EN ISO 13356:2015
English language
21 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
01-december-2015
1DGRPHãþD
SIST EN ISO 13356:2013
9VDGNL LPSODQWDWL ]DNLUXUJLMR.HUDPLþQLPDWHULDOLQDRVQRYLWHWUDJRQDOQHJD
FLUNRQLMDVWDELOL]LUDQHJD]LWULMHP <7=3  ,62
Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-
TZP) (ISO 13356:2015)
Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem
Zirkon (Y-TZP) (ISO 13356:2015)
Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisée à
l'yttrium (Y-TZP) (ISO 13356:2015)
Ta slovenski standard je istoveten z: EN ISO 13356:2015
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 13356
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 13356:2013
English Version
Implants for surgery - Ceramic materials based on yttria-
stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
Implants chirurgicaux - Produits céramiques à base de Chirurgische Implantate - Keramische Werkstoffe aus
zircone tétragonal stabilisée à l'yttrium (Y-TZP) (ISO yttriumstabilisiertem tetragonalem Zirkonium (Y-TZP)
13356:2015) (ISO 13356:2015)
This European Standard was approved by CEN on 22 August 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13356:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 13356:2015) has been prepared by Technical Committee
ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 13356:2013.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13356:2015 has been approved by CEN as EN ISO 13356:2015 without any modification.

INTERNATIONAL ISO
STANDARD 13356
Third edition
2015-09-15
Implants for surgery — Ceramic
materials based on yttria-stabilized
tetragonal zirconia (Y-TZP)
Implants chirurgicaux — Produits céramiques à base de zircone
tétragonal stabilisée à l’yttrium (Y-TZP)
Reference number
ISO 13356:2015(E)
©
ISO 2015
ISO 13356:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 13356:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Physical and chemical properties . 2
3.1 Test category . 2
3.1.1 General. 2
3.1.2 Category 1 . 2
3.1.3 Category 2 . 2
4 Test methods . 4
4.1 General . 4
4.2 Bulk density . 4
4.3 Chemical composition . 4
4.4 Microstructure . 4
4.4.1 Principle . 4
4.4.2 Test report . 5
4.4.3 Amount of monoclinic phase . 5
4.5 Biaxial flexural strength . 6
4.5.1 Principle . 6
4.5.2 Apparatus . 6
4.5.3 Preparation of test specimens . 6
4.5.4 Procedure . 7
4.5.5 Calculation of results . 8
4.5.6 Test report . 8
4.6 Four-point bending strength . 8
4.7 Weibull modulus . 9
4.8 Young’s modulus . 9
4.9 Hardness . 9
4.10 Cyclic fatigue . 9
4.10.1 Principle . 9
4.10.2 Apparatus . 9
4.10.3 Sample size and preparation of test specimens . 9
4.10.4 Procedure and sample requirement . 9
4.10.5 Test Report .10
4.11 Radioactivity .10
4.11.1 Principle .10
4.11.2 Apparatus .10
4.11.3 Sample preparation .11
4.11.4 Isotope identification - Energy calibration .11
4.11.5 Quantitative analysis .11
4.11.6 Expression of results .12
4.11.7 Test report .12
4.12 Accelerated aging test .12
4.12.1 General.12
4.12.2 Procedure .12
4.12.3 Evaluation of ac
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 5832-3:2021(Main)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
SIST EN ISO 5832-3:2022

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti-6Al-4V alloy) for use in the manufacture of surgical implants.
NOTE      The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with the specifications given in this document.

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5832-2:2018(Main)
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
SIST EN ISO 5832-2:2018

ISO 5832-2:2018 specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE      The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in ISO 5832-2:2018.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 25539-3:2024(Main)
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2024)
SIST EN ISO 25539-3:2024

This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
NOTE 1       Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, a revision of this document will be necessary.
This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites.
This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.
This document is not applicable to
—           temporary filters (e.g. tethered) that need to be removed after a defined period of time,
—           issues associated with viable tissues and non-viable biological materials, and
—           procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.
Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices.
NOTE 2       Absorbable implants are covered in ISO/TS 17137.
Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings.
NOTE 3       Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.

  • Draft
    108 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7199:2024(Main)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024)
SIST EN ISO 7199:2024

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange.
This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
This document also applies to external equipment unique to the use of the oxygenator.
This document does not apply to
—     implanted oxygenators,
—     liquid oxygenators,
—     extracorporeal circuits (blood tubing),
—     separate heat exchangers,
—     separate ancillary devices, and
—     separate arterial line filters.

  • Standard
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-1:2024(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)
SIST EN ISO 23500-1:2024

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
This document is applicable to
—     the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused.
—     the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and
—     the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
This document does not apply to
—     sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
—     systems for continuous renal replacement therapy that use pre-packaged solutions, and
—     systems and solutions for peritoneal dialysis.
This document does not address clinical issues associated with inappropriate usage of such fluids.

  • Standard
    114 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-2:2024(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
SIST EN ISO 23500-2:2024

This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies.
This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water.
This document does not apply to
—     equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients,
—     dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid,
—     sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid,
—     dialysis concentrates,
—     haemodiafiltration or haemofiltration systems,
—     systems that process dialysers for multiple uses, and
—     peritoneal dialysis systems.
Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.

  • Standard
    42 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21535:2024(Main)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)
SIST EN ISO 21535:2024

This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.
This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials.
This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2.
The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.

  • Standard
    41 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21536:2024(Main)
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)
SIST EN ISO 21536:2024

This document specifies requirements for knee-joint replacement implants. Regarding safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.
This document applies to both total and partial knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials.
This document applies to a wide variety of knee replacement implants, but for some specific knee replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2.
The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.

  • Standard
    36 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-4:2024(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
SIST EN ISO 23500-4:2024

This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
—     concentrates in both liquid and powder forms;
—     additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
—     equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
—     concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
—     pre-packaged and sterile dialysis fluid;
—     sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
—     equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.

  • Standard
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-3:2024(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
SIST EN ISO 23500-3:2024

This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
—     water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
—     water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

  • Standard
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day