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ISO-10993-55

Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity

1ST EDITION. Issued: FEB. 1, 2023. 23 pages. CURRENT

ISO-10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements

3RD EDITION. Issued: NOV. 1, 2022. 15 pages. CURRENT

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ISO-10993-7-1

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

2ND EDITION AMENDMENT 1. Issued: DEC. 1, 2019. 5 pages. CURRENT

ISO-10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

5TH EDITION. Issued: AUG. 1, 2018. 41 pages. CURRENT

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ISO-10993-10

Biological evaluation of medical devices - Part 10: Tests for skin sensitization

4TH EDITION. Issued: NOV. 1, 2021. 48 pages. CURRENT

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ISO-10993-4-1

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1

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ISO-10993-20

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

1ST EDITION. Issued: AUG. 1, 2006. 24 pages. CURRENT

ISO-10993-8

Biological evaluation of medical devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests

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ISO-10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

3RD EDITION. Issued: DEC. 1, 2016. 36 pages. CURRENT

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ISO-10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

5TH EDITION. Issued: JAN. 25, 2021. 21 pages. CURRENT

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AAMI-ST29

Recommended Practice for Determining Residual Ethylene Oxidein Medical Devices

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AAMI-ST30

Determining Residual Ethylene Chlorohydrin & Ethylene Glycol in Medical Devices

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ISO/DIS-10993-15

Part 15: Identification & Quantification of Degradation Products From Metals & Alloys, Bio

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ISO/DIS-10993-17

Part 17: Establishment of Allowable Limits for Leachable Substances, Biological Evaluation

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ISO/DIS-10993-12

Part 12: Sample Preparation & Reference Materials, Biological Evaluation of Medical Device

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ISO/DIS-10993-13

Part 13: Identification & Quantification of Degradation Products From Polymeric Medical De

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ISO/DIS-10993-11

Part 11: Tests for Systemic Toxicity, Biological Evaluationof Medical Devices -

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ISO/FDIS-10993-18

Biological Evaluation Of Medical Devices - Part 18: Chemical Characterization Of Medical Device Materials Within A Risk Management Process

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FDA-G95-1

Use of International Standard ISO-10993, 'Biological Evaluation of Medical 28 Devices Part 1: Evaluation and Testing,'

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