OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2003, IDT)
This Malaysian Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OEs, this standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilisation, product packaging, product labelling and the information supplied by the manufacturer.
Published
• (none) / (none) / (none)
PDF
14/04/2019
21
NSC 18 - Medical Devices and Facilities for Healthcare
