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SRPS EN ISO 14607:2018

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

Oct 31, 2018

General information

60.60     Oct 31, 2018

ISS

Z076

European Norm

11.040.40  

English  

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Published

Language in which you want to receive the document.

Scope

ISO 14607:2018 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 14607:2011

NOW

PUBLISHED
SRPS EN ISO 14607:2018
60.60 Standard published
Oct 31, 2018

REVISED BY

PROJECT
dnaSRPS EN ISO 14607:2022

Related project

Adopted from EN ISO 14607:2018

Adopted from ISO 14607:2018