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ISO 11607-1:2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
31. 1. 2019.

Опште информације

90.93     5. 7. 2024.

ISO

ISO/TC 198

Međunarodni standard

11.080.30  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11607-1:2006

POVUČEN
ISO 11607-1:2006/Amd 1:2014

TRENUTNO

OBJAVLJEN
ISO 11607-1:2019
90.93 Odluka o potvrđivanju standarda
5. 7. 2024.

ISPRAVKE / IZMENE

NAPUŠTEN
ISO 11607-1:2019/CD Amd 1

OBJAVLJEN
ISO 11607-1:2019/Amd 1:2023

Nacionalna preuzimanja

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

60.60 Standard objavljen