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EN 15986:2011 Standard

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  Keywords:

#standard #requirements #european #specify #devices

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

  Purpose

This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041. This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 8185:2009

Medical devices Directive (93/42/EEC)

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

EN 60601-2-51:2003

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and an...

EN 61217:2012

Medical devices Directive (93/42/EEC)

Radiotherapy equipment - Coordinates, movements and scalesIEC 61217:2011

EN 60645-4:1995

Medical devices Directive (93/42/EEC)

Audiometers - Part 4: Equipment for extended high-frequency audiometryIEC 60645-4:1994

EN 60645-3:2007

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiometric equipment - Part 3: Test signals of short durationIEC 60645-3:2007

EN 60645-2:1997

Medical devices Directive (93/42/EEC)

Audiometers - Part 2: Equipment for speech audiometryIEC 60645-2:1993

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