SK EN ISO 16061:2017

Status: Published
Gjuha: English
Faqe: 26
Publikuar: 2017-12-01
Regjistri Kombëtar: 213/2017
Botim:

Standardet ndërkombëtare që kanë lidhje

This standard is identical to:
EN ISO 16061:2015
CEN/TC 285

This standard is identical to:
ISO 16061:2015
ISO/TC 150

Çmim: 26 €

Titulli Shqip

Instrumente për përdorim me implantet kirurgjikale jo aktive - Kërkesa të përgjithshme (ISO 16061:2015)

Titulli Anglisht

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.