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DIN EN ISO 21536

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014) (includes Amendment :2014)

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Organization: DIN
Publication Date: 1 July 2014
Status: active
Page Count: 13
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

Document History

DIN EN ISO 21536
August 1, 2021
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021); German and English version prEN ISO 21536:2021
A description is not available for this item.
DIN EN ISO 21536
July 1, 2014
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014) (includes Amendment :2014)
This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance,...
DIN EN ISO 21536
August 1, 2009
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
A description is not available for this item.
DIN EN ISO 21536/A1
February 1, 2009
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants; English version prEN ISO 21536:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 21536
December 1, 2007
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
A description is not available for this item.

References

This document references:
DIN EN ISO 14630 - Non-active surgical implants - General requirements (ISO 14630:2012)
Published by DIN on March 1, 2013
A description is not available for this item.
This document references:
DIN EN ISO 21534 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007); German version EN ISO 21534:2009
Published by DIN on August 1, 2009
A description is not available for this item.
This document references:
ISO 14243-1 - Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
Published by ISO on November 15, 2009
This part of ISO 14243 specifies the flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration...
This document references:
ISO 14243-2 - Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
Published by ISO on September 1, 2016
This part of ISO 14243 specifies a method of assessment of wear of the tibial component of total kneejoint prostheses using the gravimetric technique for components tested in accordance with ISO...
This document references:
ISO 14243-3 - Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
Published by ISO on November 1, 2014
This part of ISO 14243 describes a test method that specifies flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of...
This document references:
ISO 14630 - Non-active surgical implants - General requirements
Published by ISO on December 1, 2012
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants,...
This document references:
ISO 14879-1 - Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays
Published by ISO on July 1, 2020
This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic...
This document references:
ISO 21534 - Non-active surgical implants Joint replacement implants Particular requirements
Published by ISO on October 1, 2007
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the...
This document references:
ISO 7207-1 - Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
Published by ISO on February 1, 2007
This part of ISO 7207 classifies femoral, tibial and patellar components for knee joint prostheses in which the bearing surfaces of one or more compartments of the knee are replaced. It also gives...
This document references:
ISO 7207-2 - Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials AMENDMENT 2
Published by ISO on June 1, 2020
A description is not available for this item.
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