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EN ISO 10651-6:2009 Standard

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  Keywords:

#home #part #intended #amendments #modify

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

  Purpose

This part of ISO 10651 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. The requirements of this part of ISO 10651 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10651-6:2004"

Anyway is still possible use the "EN ISO 10651-6:2004" until March 21st, 2010

  Related Standards

EN 455-3:2006

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Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN ISO 10993-15:2009

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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and allo...

EN ISO 10651-4:2009

Medical devices Directive (93/42/EEC)

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

EN ISO 10993-1:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-3:2014

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

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