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EN 455-1:2000 Standard

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  Keywords:

#requirements #active #implantable #medical #devices

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

  Purpose

This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 455-1:1993"

Anyway is still possible use the "EN 455-1:1993" until April 30th, 2001

  Related Standards

EN 455-3:2006

Medical devices Directive (93/42/EEC)

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

EN 455-4:2009

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

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 556-1:2001/AC:2006

Medical devices Directive (93/42/EEC)

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

EN 556-2:2015

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN 1041:2008

Medical devices Directive (93/42/EEC)

Information supplied by the manufacturer of medical devices

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