SSH EN ISO 21534:2009

Implante kirurgjikalë joaktivë - Implante të nyjeve të rivendosshme - Kërkesa të veçanta (ISO 21534:2007)

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

Scope

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.

Related directives

Directives related to this standards.