884862

AAMI TIR 15843

Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

standard by Association for the Advancement of Medical Instrumentation , 01/01/2001

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Full Description

Describes methods and rationale for changing the number of product units required for dose setting verification and dose audits as defined in annex B of ANSI/AAMI/ISO 11137.
 

Product Details

Published:
01/01/2001
ANSI:
ANSI Approved
Number of Pages:
33
File Size:
1 file , 130 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & A2:2019 (Consolidated Text)


    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019

    • Most Recent

  2. AAMI/ISO 11137-1:2006/(R)2010


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

    • Historical Version

  3. AAMI/ISO 11137:1994 + Amendment 1


    Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization, 3ed.

    • Historical Version

  4. AAMI TIR 15843

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    Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

    • Historical Version

  5. AAMI ST1137-94


    Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization

    • Historical Version