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    • Biological evaluation of medical devices
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    ISO 10993-15 : 2001

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS

    International Organization for Standardization

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    ISO/FDIS 10993-23:2020

    Biological evaluation of medical devices — Part 23: Tests for irritation

    International Organization for Standardization

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    ISO/TS 10993-19 : 2020

    Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

    International Organization for Standardization

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    ISO 10993-7:2008/AMD 1:2019

    Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

    International Organization for Standardization

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    ISO 10993-7:2008/FDAmd 1 : 2019

    Biological evaluation of medical devices — Part 7:Ethylene oxide sterilization residuals AMENDMENT 1

    International Organization for Standardization

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    ISO/FDIS 10993-15 : 2019

    Biological evaluation of medical devices — Part 15:Identification and quantification of degradation products from metals and alloys

    International Organization for Standardization

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    ISO/PRF 20776-1 : 2019

    Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

    International Organization for Standardization

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    ISO/TS 21726:2019

    Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

    International Organization for Standardization

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    ISO/DIS 22442-1 : 2018

    Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management

    International Organization for Standardization

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    ISO TR 10993-22 : 2017

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 22: GUIDANCE ON NANOMATERIALS

    International Organization for Standardization

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