Complete List of the ISO 10993 Standards on Biological Evaluation of Medical Devices
ISO-10993-1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 5TH EDITION. Issued: AUG. 1, 2018. 41 pages. CURRENT Show ISO-10993-1 revision history |
$216.31 |
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ISO-10993-2Biological evaluation of medical devices - Part 2: Animal welfare requirements 3RD EDITION. Issued: NOV. 1, 2022. 15 pages. CURRENT Show ISO-10993-2 revision history |
$120.28 |
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ISO-10993-3Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 3RD EDITION. Issued: OCT. 1, 2014. 41 pages. CURRENT Show ISO-10993-3 revision history |
$188.18 |
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ISO-10993-4Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood 3RD EDITION. Issued: APRIL 1, 2017. 76 pages. CURRENT Show ISO-10993-4 revision history |
$242.50 |
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ISO-10993-4-1Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 Show ISO-10993-4-1 revision history |
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ISO-10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity 3RD EDITION. Issued: JUNE 1, 2009. 41 pages. CURRENT Show ISO-10993-5 revision history |
$188.18 |
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ISO-10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation 3RD EDITION. Issued: DEC. 1, 2016. 36 pages. CURRENT Show ISO-10993-6 revision history |
$188.18 |
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ISO-10993-7Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 2ND EDITION. Issued: OCT. 15, 2008. 93 pages. CURRENT Show ISO-10993-7 revision history |
$269.66 |
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ISO-10993-9Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 3RD EDITION. Issued: NOV. 1, 2019. 11 pages. CURRENT Show ISO-10993-9 revision history |
$78.57 |
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ISO-10993-10Biological evaluation of medical devices - Part 10: Tests for skin sensitization 4TH EDITION. Issued: NOV. 1, 2021. 48 pages. CURRENT Show ISO-10993-10 revision history |
$216.31 |
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ISO-10993-11Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 3RD EDITION. Issued: SEPT. 1, 2017. 36 pages. CURRENT Show ISO-10993-11 revision history |
$188.18 |
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ISO-10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials 5TH EDITION. Issued: JAN. 25, 2021. 21 pages. CURRENT Show ISO-10993-12 revision history |
$161.02 |
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ISO-10993-13Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 2ND EDITION. Issued: JUNE 15, 2010. 21 pages. CURRENT Show ISO-10993-13 revision history |
$120.28 |
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ISO-10993-14Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics 1ST EDITION. Issued: NOV. 15, 2001. 18 pages. CURRENT |
$78.57 |
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ISO-10993-15Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys 2ND EDITION. Issued: NOV. 1, 2019. 15 pages. CURRENT Show ISO-10993-15 revision history |
$120.28 |
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ISO-10993-16Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables 3RD EDITION. Issued: MAY 1, 2017. 20 pages. CURRENT Show ISO-10993-16 revision history |
$120.28 |
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ISO-10993-17Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents 2ND EDITION. Issued: SEPT. 1, 2023. 65 pages. CURRENT Show ISO-10993-17 revision history |
$242.50 |
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ISO-10993-18Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process 2ND EDITION. Issued: JAN. 1, 2020. 66 pages. CURRENT Show ISO-10993-18 revision history |
$242.50 |
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ISO-10993-19Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials 2ND EDITION. Issued: MARCH 1, 2020. 13 pages. CURRENT Show ISO-10993-19 revision history |
$120.28 |
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ISO-10993-20Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices 1ST EDITION. Issued: AUG. 1, 2006. 24 pages. CURRENT |
$120.28 |