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 16061:2008, Corrected version 2009-03-15)
Scope Shqip
Asnjë informacion i shtuar.
Scope Anglisht
ISO 16061:2008 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.
ISO 16061:2008 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, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
Komitetet Teknike
ICS
Direktivë
Veprim Kombëtar
SK EN ISO 16061:2017
replaces
SK EN ISO 16061:2016
- 2016-07-22
Numri Standardit
Gjuha
Status
Publikuar
Faqe
Çmim
Blej
Published
2017-12-01
26
26 €
Instrumente për përdorim me implantet kirurgjikale jo aktive - Kërkesa të përgjithshme (ISO 16061:2015)