:: Questions & Answers

EFHSS Questions and Answers - Answer to Question Q00727

Categories Authors Questions Unanswered Questions Questions with Answers Questions and Answers Submit New Question Help

Category Sort By Sort Order

View

Please fill out the following form and submit it to post a reply and/or answer to question Q00727 to the EFHSS Questions and Answers pages. For new questions please use the Submit New Question form instead.

EFHSS Questions and Answers - Answer to Question Q00727
Your Details:
Name:
Email:
Country:
Your answer/reply:
Message:

Please contact/notify if you have any questions and/or problems using the EFHSS Questions and Answers pages.

EFHSS - Questions & Answers - Sterile Storage - Q00727
Norms or requirements by Governments for Sterile Shelving for Sterile Storage Areas

Follow Up
Web Search

From: (South Africa) Date: 25 January 2005, 12:28 [GMT]
Subject: Norms or requirements by Governments for Sterile Shelving for Sterile Storage Areas

We are a South African manufacturer of sterile shelving for the local and international market. My question: Is there a Government document specifying Criteria that sterile shelving and related products must meet in the European, American, and the rest of the world.
Where would this document be available?

Kind Regards,
Julian Hutz

From: (France) Date: 26 January 2005, 10:47 [GMT]
Subject: Re: Norms or requirements by Governments for Sterile Shelving for Sterile Storage Areas

Regarding the sterile devices to be stored, the new ISO11607-1 brings new recommendation and new terminology like "packaging system" that is the new term to define the sterilisation packaging (sterile barrier) + protective packaging. (Chapter 5.5, Chapter 6).
The use of a protective packaging allows to increase the expiry date depending of the type of device.
In fact, we'll have to consider a protective packaging to maintain the integrity of the sterile barrier (sterilisation packaging).
In addition to this, the organization of the sterile area should be done with storage areas dedicated to the different type of packaging and devices.

^<>>

:: Questions & Answers