NF EN ISO 11607-2

NF EN ISO 11607-2

January 2020
Standard Current mandatory application standard
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Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes

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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2020

Number of pages

22 p.

Reference

NF EN ISO 11607-2

ICS Codes

11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Classification index

S98-052-2

Print number

1

International kinship

ISO 11607-2:2020

European kinship

EN ISO 11607-2:2020
Sumary
Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes

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.

Replaced standards (1)
NF EN ISO 11607-2
January 2018
Standard Cancelled
Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes

Le présent document spécifie les exigences pour la mise au point et la validation des procédés d'emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le formage, le scellage et l'assemblage de systèmes de barrière stérile préformés, de systèmes de barrière stérile et de systèmes d'emballage.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Validation des procédés d'emballage
  • 6 Assemblage
  • 7 Utilisation des systèmes de barrière stérile réutilisables
  • 8 Emballage de dispositif pour passage de fluides stériles
  • Annexe A Mise au point du procédé
  • Bibliographie
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