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Glavni meni

ISO 11607-1:2006

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
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 11607-1:2006 specifies the 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.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11607:2003

TRENUTNO

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

ISPRAVKE / IZMENE

POVUČEN
ISO 11607-1:2006/Amd 1:2014

REVIDIRAN OD

OBJAVLJEN
ISO 11607-1:2019

Nacionalna preuzimanja

Ambalaža za terminalno sterilizovana medicinska sredstva - Deo 1: Zahtevi za materijale, sterilne pregradne sisteme i ambalažne sisteme

95.99   Povučen

Ambalaža za terminalno sterilisana medicinska sredstva — Deo 1: Zahtevi za materijale, sterilne pregradne sisteme i ambalažne sisteme

95.99   Povučen

Ambalaža za terminalno sterilisana medicinska sredstva – Deo 1: Zahtevi za materijale, sterilne pregradne sisteme i ambalažne sisteme

95.99   Povučen