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DIN EN ISO 14607

Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2018, korrigierte Fassung 2018-08); Deutsche Fassung EN ISO 14607:2018

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Organization: DIN
Publication Date: 1 October 2018
Status: active
Page Count: 58
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

Dieses Dokument legt besondere Anforderungen an Mammaimplantate fest.

Im Hinblick auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Verpackung, Sterilisation und vom Hersteller zu liefernde Informationen fest.

Document History

DIN EN ISO 14607
September 1, 2023
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO/DIS 14607:2023); Deutsche und Englische Fassung prEN ISO 14607:2023
A description is not available for this item.
DIN EN ISO 14607
October 1, 2018
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2018, korrigierte Fassung 2018-08); Deutsche Fassung EN ISO 14607:2018
Dieses Dokument legt besondere Anforderungen an Mammaimplantate fest. Im Hinblick auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale,...
DIN EN ISO 14607
May 1, 2017
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO/DIS 14607:2017); Deutsche und Englische Fassung prEN ISO 14607:2017
A description is not available for this item.
DIN EN ISO 14607
August 1, 2009
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007); Deutsche Fassung EN ISO 14607:2009
A description is not available for this item.
DIN EN ISO 14607/A1
February 1, 2009
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007); Englische Fassung prEN ISO 14607:2008, Aenderung 1
A description is not available for this item.
DIN EN ISO 14607
May 1, 2007
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007); Deutsche Fassung EN ISO 14607:2007
A description is not available for this item.
DIN EN ISO 14607
March 1, 2005
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Mammaimplantate (ISO/DIS 14607:2005); Deutsche Fassung prEN ISO 14607:2005
A description is not available for this item.
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References

This document references:
ASTM D2240 - Standard Test Method for Rubber Property-Durometer Hardness
Published by ASTM on August 1, 2015
This test method covers twelve types of rubber hardness measurement devices known as durometers: Types A, B, C, D, DO, E, M, O, OO, OOO, OOO-S, and R. The procedure for determining indentation...
This document references:
D412 - Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
November 1, 2016
These test methods cover procedures used to evaluate the tensile (tension) properties of vulcanized thermoset rubbers and thermoplastic elastomers. These methods are not applicable to ebonite and...
This document references:
ASTM D624 - Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
Published by ASTM on July 10, 2000
This test method describes procedures for measuring a property of conventional vulcanized rubber and thermoplastic elastomers called tear strength. The values stated in SI units are to be regarded as...
This document references:
ASTM D792 - Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
Published by ASTM on July 1, 2020
These test methods describe the determination of the specific gravity (relative density) and density of solid plastics in forms such as sheets, rods, tubes, or molded items. Two test methods are...
This document references:
F703 - Standard Specification for Implantable Breast Prostheses
February 1, 2018
This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation,...
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