Skip to main content
Tagasi

ISO 23089-2:2021

Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices

Üldinfo

Kehtiv alates 28.05.2021
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
28.05.2021
Põhitekst
This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures.
This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.

Nõutud väljad on tähistatud *

*
*
*
PDF
55,07 € koos KM-ga
Paber
55,07 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Muudatus

ISO 7206-13:2016/Amd 1:2022

Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components — Amendment 1
Uusim versioon Kehtiv alates 05.05.2022
Põhitekst

ISO 17664-1:2021

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
Uusim versioon Kehtiv alates 06.07.2021
Põhitekst

EVS-EN 868-8:2018

Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Uusim versioon Kehtiv alates 03.01.2019
Muudatus

EVS-EN ISO 11607-1:2020/A11:2022

Lõplikult steriliseeritud meditsiiniseadme pakendamine. Osa 1: Nõuded materjalile, steriilsele barjäärile ja pakendusele
Kehtiv alates 01.07.2022