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EN ISO 11607-1:2020 Standard

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  Keywords:

#requirements #device #systems #control #system

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

  Purpose

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

  Publication

Wednesday 14th of April 2021

  Related Standards

EN 1422:1997+A1:2009

Medical devices Directive (93/42/EEC)

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

EN 62220-1-3:2008

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Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum...

EN 60645-2:1997

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

EN 60645-4:1995

Medical devices Directive (93/42/EEC)

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

EN 61217:2012

Medical devices Directive (93/42/EEC)

Radiotherapy equipment - Coordinates, movements and scalesIEC 61217:2011

EN 61676:2002

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiol...

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