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EFHSS Questions and Answers - Answer to Question Q00618

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EFHSS - Questions & Answers - Low Temperature Sterilization - Q00618
Permissible limit of EtO 		Follow Up
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From: (India)   Date: 28 September 2004, 09:08 [GMT]
Subject: Permissible limit of EtO
  1. What is the permissible limit of Eto and EO sterilized surgical rubber gloves
  2. Documentary evidence for confirmation of the same
From: Josy Holdener   Date: 1 October 2004, 16:08 [GMT]
Subject: Re: Permissible limit of EtO

Dear Joseph

The international standard ISO 10993-7, "Biological Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals," specifies the requiremnts for establishing allowable limits for ETO residues and the analytical methods to show that an ETO-sterilized device is in compliance with allowable limits.
For more information visit: www.devicelink.com/mddi/archive/98/02/016.html for "Guide to AAMI Tir-19" and for "ETO Residuals / A guide to ISO 10003-7 and AAMI Tir-19 for ETO Sterilized Devices" www.devicelink.com/mddi/archive/00/02/007.html.
The website devicelink.com also has a Help Desk. Where to go for ETO Info.
I hope this is of some help.

Kind regards
Josy Holdener
EFHSS  European Forum for Hospital Sterile Supply

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