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EN ISO 17665-1:2006 Standard

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  Keywords:

#medical #devices #sterilization #health #care

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

  Purpose

This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 554:1994"

Anyway is still possible use the "EN 554:1994" until August 31st, 2009

  Related Standards

EN 60601-2-30:2000

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EN ISO 10079-3:2009

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Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

EN ISO 10651-2:2009

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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN ISO 10524-4:2008

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Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN ISO 10524-3:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

EN ISO 10524-2:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

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