ANSI/AAMI/ISO 11135:2014/A1:2018, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices?Amendment 1: Revision of Annex E, Single batch release

Text Registration

ANSI/AAMI/ISO 11135:2014/A1:2018, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices?Amendment 1: Revision of Annex E, Single batch release

Status

Published

on 9 Aug 2021

Year of Creation

2020

Association for the Advancement of Medical Instrumentation

Registration Number

TX0009000452

on 9 Aug 2021

The U.S. Copyright record (Registration Number: TX0009000452) dated 9 Aug 2021, pertains to an electronic file (eService) titled "ANSI/AAMI/ISO 11135:2014/A1:2018, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices?Amendment 1: Revision of Annex E, Single batch release" created in 2020. The copyright holder is Association for the Advancement of Medical Instrumentation, known for their creative contributions in text registration. For any inquiries concerning this copyrighted material, kindly reach out to Association for the Advancement of Medical Instrumentation.

Association for the Advancement of Medical Instrumentation

Application Details

Registration Number

TX0009000452

Registration Date

8/9/2021

Year of Creation

2020

Agency Marc Code

DLC-CO

Record Status

New

Corporate Author

Association for the Advancement of Medical Instrumentation

Physical Description

Electronic file (eService)

First Publication Nation

United States

ISBN

978-1-57020-745-7

Corporate Authors

Association for the Advancement of Medical Instrumentation

Notes

Rights Note: Barbara Saxton, Association for the Advancement of Medical Instrumentation, 901 North Glebe Rd., Suite 300, Arlington, VA, 22203, United States, (703) 525-4890, bsaxton@aami.org

Statements

Application Title Statement: ANSI/AAMI/ISO 11135:2014/A1:2018, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices?Amendment 1: Revision of Annex E, Single batch release

Author Statement: Association for the Advancement of Medical Instrumentation employer for hire Domicile: United States Citizenship: United States Authorship: text

Notes

Rights Note: Barbara Saxton, Association for the Advancement of Medical Instrumentation, 901 North Glebe Rd., Suite 300, Arlington, VA, 22203, United States, (703) 525-4890, bsaxton@aami.org

Statements

Author Statement: Association for the Advancement of Medical Instrumentation employer for hire Domicile: United States Citizenship: United States Authorship: text

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