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EN ISO 14607:2018 Standard

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  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

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