Draft
International Standard
ISO/DIS 19227
Implants for surgery — Cleanliness of orthopedic implants — General requirements
Reference number
ISO/DIS 19227
Edition 2
Proyecto Norma internacional
ISO/DIS 19227
89264
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
Reemplazará ISO 19227:2018

Resumen

ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.

ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.

ISO 19227:2018 applies to in-process cleaning and final cleaning.

ISO 19227:2018 does not apply to liquid or gaseous implants.

ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.

Informaciones generales

  •  : En desarrollo
    : DIS registrado [40.00]
  •  : 2
     : 71
  • ISO/TC 150
    11.040.40 
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