2021

ANSI/AAMI/ISO 10993-16:2017, Biological evaluation of medical devices?Part 16: Toxicokinetic study design for degradation products and leachables

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Text Registration

ANSI/AAMI/ISO 10993-16:2017, Biological evaluation of medical devices?Part 16: Toxicokinetic study design for degradation products and leachables

Status

Published

on 6 Aug 2021

Year of Creation

2020

Association for the Advancement of Medical Instrumentation

Registration Number

TX0009000161

on 6 Aug 2021

The U.S. Copyright record (Registration Number: TX0009000161) dated 6 Aug 2021, pertains to an electronic file (eService) titled "ANSI/AAMI/ISO 10993-16:2017, Biological evaluation of medical devices?Part 16: Toxicokinetic study design for degradation products and leachables" 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

TX0009000161

Registration Date

8/6/2021

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

978-1-57020-778-5

Preexisting Material

text

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

Material Matter Claimed Note: text

Previous Registration Note: 2010, TX00072901611997, TX0008630607

Statements

Application Title Statement: ANSI/AAMI/ISO 10993-16:2017, Biological evaluation of medical devices?Part 16: Toxicokinetic study design for degradation products and leachables

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

Material Matter Claimed Note: text

Previous Registration Note: 2010, TX00072901611997, TX0008630607

Statements

Application Title Statement: ANSI/AAMI/ISO 10993-16:2017, Biological evaluation of medical devices?Part 16: Toxicokinetic study design for degradation products and leachables

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

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