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EN ISO 11607-2:2020 Standard

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  Keywords:

#systems #packaging #barrier #sterile #cover

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

  Purpose

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

  Publication

Wednesday 14th of April 2021

  Related Standards

EN ISO 13408-5:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN 794-3:1998+A2:2009

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Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

EN ISO 13485:2016/AC:2018

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN 12470-4:2000+A1:2009

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Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

EN 12006-3:1998+A1:2009

Medical devices Directive (93/42/EEC)

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

EN ISO 11608-7:2017

Medical devices Directive (93/42/EEC)

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual imp...

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