Standard Svensk standard · SS-EN ISO 16061:2021

Kirurgiska instrument för arbete med icke aktiva kirurgiska implantat - Allmänna krav (ISO 16061:2021)

Status: Gällande

Köp denna standard

Standard Svensk standard · SS-EN ISO 16061:2021

Kirurgiska instrument för arbete med icke aktiva kirurgiska implantat - Allmänna krav (ISO 16061:2021)
Prenumerera på standarden - Läs mer Dölj
Pris: 875 SEK
standard ikon pdf

PDF

Pris: 875 SEK
standard ikon

Papper

Pris: 1 400 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ
Omfattning
This document specifies the general requirements for instruments to be used in association with nonactive
surgical implants. These requirements apply to instruments when they are manufactured and
when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in
association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it
does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design
attributes, materials, design evaluation, manufacture, sterilization, packaging, and information
supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and
transradicular implants and ophthalmic implants.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40) Övrig medicinsk utrustning (11.040.99)


Köp denna standard

Standard Svensk standard · SS-EN ISO 16061:2021

Kirurgiska instrument för arbete med icke aktiva kirurgiska implantat - Allmänna krav (ISO 16061:2021)
Prenumerera på standarden - Läs mer Dölj
Pris: 875 SEK
standard ikon pdf

PDF

Pris: 875 SEK
standard ikon

Papper

Pris: 1 400 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

Framtagen av: Implantat, SIS/TK 340/AG 03

Internationell titel: Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

Artikelnummer: STD-80028451

Utgåva: 4

Fastställd: 2021-04-06

Antal sidor: 28

Ersätter: SS-EN ISO 16061:2015