NF EN ISO 11607-2/A1

NF EN ISO 11607-2/A1

September 2014
Standard Cancelled

Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes - Amendment 1

Le présent amendement porte principalement sur des révisions éditoriales notamment sur les mises à jour des références normatives et documents cités en Bibliographie.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

September 2014

Number of pages

10 p.

Reference

NF EN ISO 11607-2/A1

ICS Codes

11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Classification index

S98-052-2/A1

Print number

1

International kinship

ISO 11607-2/A1:2014

European kinship

EN ISO 11607-2/A1:2014
Sumary
Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes - Amendment 1

Le présent amendement porte principalement sur des révisions éditoriales notamment sur les mises à jour des références normatives et documents cités en Bibliographie.
Standard replaced by (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.

ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ