NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2008, IDT)
This Malaysian Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Published
• (none) / (none) / (none)
PDF
30/03/2019
25
NSC 18 - Medical Devices and Facilities for Healthcare
