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EN 1639:2009 Standard

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  Keywords:

#standard #european #energy #requirements #practice

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Dentistry - Medical devices for dentistry - Instruments

  Purpose

This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 1639:2004"

Anyway is still possible use the "EN 1639:2004" until April 30th, 2010

  Related Standards

EN ISO 11140-1:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN 556-1:2001

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN ISO 17510-2:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

EN ISO 17510-1:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

EN ISO 16201:2006

Medical devices Directive (93/42/EEC)

Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)

EN ISO 16061:2009

Medical devices Directive (93/42/EEC)

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version...

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