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SRPS EN ISO 17509:2017

Dentistry - Torque transmitter for handpieces (ISO 17509:2016)

Sep 25, 2017

General information

60.60     Sep 25, 2017

ISS

Z106

European Norm

11.060.25     11.060.20  

English  

Plan 2017.

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Scope

ISO 17509:2016 specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area.
ISO 17509:2016 applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves.
ISO 17509:2016 does not include the dental implant nor parts that would be connected to it.
With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
SRPS EN ISO 17509:2017
60.60 Standard published
Sep 25, 2017

Related project

Adopted from EN ISO 17509:2016

Adopted from ISO 17509:2016