1587745

AAMI/ISO TIR11135-2:2008

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 09/23/2008

This document has been replaced. View the most recent version.

View all product details

Historical

Track It

Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $204.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

Order as a set with AAMI/ISO 11135-1:2007 and save!

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.
 

Product Details

Published:
09/23/2008
ANSI:
ANSI Approved
Number of Pages:
59
File Size:
1 file , 450 KB
Part of:
AAMI/ISO 11135-1 / 11135-2 SET, AAMI STBK10-3
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 11135:2014


    Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    • Most Recent

  2. AAMI/ISO TIR11135-2:2008

    👀 currently
    viewing


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

    • Historical Version

  3. AAMI/ISO 11135-1 / 11135-2 SET


    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)

    • Historical Version

  4. AAMI/ISO 11135-1:2007


    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Historical Version

  5. AAMI 11135:1994


    Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata

    • Historical Version