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ISO 14607

Non-active surgical implants - Mammary implants - Particular requirements

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Organization: ISO
Publication Date: 1 April 2018
Status: active
Page Count: 50
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document specifies particular requirements for mammary implants.

With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer

Document History

DIS 14607
August 11, 2023
Non-active surgical implants — Mammary implants — Specific requirements
This document specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design...
ISO 14607
April 1, 2018
Non-active surgical implants - Mammary implants - Particular requirements
This document specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design...
14607
April 1, 2018
Non-active surgical implants - Mammary implants - Particular requirements
This document specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design...
ISO 14607
February 15, 2007
Non-active surgical implants — Mammary implants — Particular requirements
A description is not available for this item.
ISO 14607
November 1, 2002
Implants for surgery Specific requirements for mammary implants
A description is not available for this item.

References

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:
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,...
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 is referenced by:
DIN EN 16844 - Dienstleistungen in der aesthetischen Medizin - Nicht-chirurgische, medizinische Behandlungen; Deutsche Fassung EN 16844:2017+A2:2019
Published by DIN on October 1, 2019
A description is not available for this item.
This document is referenced by:
EN 16844 - Aesthetic medicine services - Non-surgical medical treatments
Published by CEN on June 1, 2017
This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments: — treatments with resorbable injectables, botulinum toxin and micro needling; — treatments...
This document is referenced by:
ISO 14630 FRENCH - Implants chirurgicaux non actifs - Exigences générales
Published by ISO on December 1, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 14630 - Non-active surgical implants - General requirements
Published by BSI on December 31, 2012
A description is not available for this item.
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