Објављен
ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
ПОВУЧЕН
ISO 21534:2002
ОБЈАВЉЕН
ISO 21534:2007
90.93
Одлука о потврђивању стандарда
3. 9. 2021.
Neaktivni hirurški implantati- Zamenjivi zglobni implantati – Posebn zahtevi
60.60 Стандард објављен