AAMI/ISO TIR11135-2:2008 PDF

AAMI/ISO TIR11135-2:2008 PDF

Name:
AAMI/ISO TIR11135-2:2008 PDF

Published Date:
09/23/2008

Status:
Active

Description:

Sterilization of health care products - Ethylene oxide--- Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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$61.2
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This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.

The exclusions in ISO 11135-1 apply also to this Technical Specification.

For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification..

This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135- 1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
ANSI : ANSI Approved
File Size : 1 file , 450 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 59
Part of : AAMI/ISO 11135-1 / 11135-2 SET, AAMI STBK10-3
Published : 09/23/2008

History

AAMI/ISO TIR11135-2:2008
Published Date: 09/23/2008
Sterilization of health care products - Ethylene oxide--- Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
$61.2
AAMI/ISO 11135-1 / 11135-2 SET
Published Date: 09/23/2008
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (11135-1:2007) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008)
AAMI/ISO 11135-1:2007
Published Date: 07/25/2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
$61.2

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