Need help?

EN ISO 14607:2018 Standard

wave
Save  

  Keywords:

#specifies #design #implants #iso #information

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Wednesday 14th of April 2021

  Related Standards

EN ISO 1135-4:2011

Medical devices Directive (93/42/EEC)

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)

EN ISO 9713:2009

Medical devices Directive (93/42/EEC)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

EN ISO 10555-1:2009

Medical devices Directive (93/42/EEC)

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

EN ISO 10535:2006

Medical devices Directive (93/42/EEC)

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

EN ISO 10524-4:2008

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN ISO 10524-3:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 14607:2018 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0