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Glavni meni

ISO 11607-2:2006

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
7. 4. 2006.
95.99   Povučen   31. 1. 2019.

Опште информације

95.99     31. 1. 2019.

ISO

ISO/TC 198

Međunarodni standard

11.080.30  

engleski   francuski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 11607-2:2006 specifies the requirements for 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.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11607:2003

TRENUTNO

POVUČEN
ISO 11607-2:2006
95.99 Povučen
31. 1. 2019.

ISPRAVKE / IZMENE

POVUČEN
ISO 11607-2:2006/Amd 1:2014

REVIDIRAN OD

OBJAVLJEN
ISO 11607-2:2019

Nacionalna preuzimanja

Ambalaža za terminalno sterilizovana medicinska sredstva - Deo 2: Validacija zahteva za procese oblikovanja, zatvaranja i sklapanja

95.99   Povučen

Ambalaža za terminalno sterilisana medicinska sredstva – Deo 2: Validacija zahteva za procese oblikovanja, zatvaranja i sklapanja

95.99   Povučen