This Malaysian Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this Malaysian Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
?It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.
Published
N/A
PDF
02/05/2019
25
NSC 18 - Medical Devices and Facilities for Healthcare
