SFS-EN ISO 13504:en

Soveltamisala

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ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Tuoteryhmä(t)

11.040 Terveydenhuollon laitteet »
11.060.25 Hammashoitoinstrumentit »

Sidokset

Velvoittavat viittaukset

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ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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Tekninen komitea

CEN/TC 55 Dentistry »

Vahvistuspäivä

17.09.2012

Julkaisupäivä

05.10.2012

Painos

1

Sivumäärä

19

Julkaisun kieli

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