Complete list of the Harmonized Standards for 90/385/eec
List of European Harmonized Standards For Directive 90/385/EEC, Active Implantable Medical Devices (with links to the Official English Language Edition of each)
EN-556-1Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' 2001 EDITION. Issued: DEC. 11, 2001. 12 pages. CURRENT |
$143.00 |
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EN-556-2Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' 2015 EDITION. Issued: SEPT. 30, 2015. 20 pages. CURRENT Show EN-556-2 revision history |
$169.00 |
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EN-980Symbols for use in the labelling of medical devices Show EN-980 revision history |
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EN-1041Information supplied by the manufacturer of medical devices Show EN-1041 revision history |
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EN-ISO-10993-1Biological evaluation of medical devices 2020 EDITION. Issued: DEC. 16, 2020. 50 pages. CURRENT Show EN-ISO-10993-1 revision history |
$300.00 |
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EN-ISO-10993-5Biological evaluation of medical devices 2009 EDITION. Issued: JULY 31, 2009. 46 pages. CURRENT Show EN-ISO-10993-5 revision history |
$300.00 |
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EN-ISO-10993-6Biological evaluation of medical devices 2016 EDITION. Issued: DEC. 31, 2016. 46 pages. CURRENT Show EN-ISO-10993-6 revision history |
$300.00 |
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EN-ISO-10993-7Biological evaluation of medical devices 2008/A1 EDITION. Issued: JAN. 26, 2022. 98 pages. CURRENT Show EN-ISO-10993-7 revision history |
$361.25 |
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EN-ISO-10993-9Biological evaluation of medical devices 2021 EDITION. Issued: MAY 19, 2022. 24 pages. CURRENT Show EN-ISO-10993-9 revision history |
$249.60 |
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EN-ISO-10993-11Biological evaluation of medical devices 2018 EDITION. Issued: JUNE 18, 2018. 38 pages. CURRENT Show EN-ISO-10993-11 revision history |
$267.50 |
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EN-ISO-10993-12Biological evaluation of medical devices 2021 EDITION. Issued: JUNE 21, 2021. 34 pages. CURRENT Show EN-ISO-10993-12 revision history |
$272.50 |
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EN-ISO-10993-13Biological evaluation of medical devices 2010 EDITION. Issued: OCT. 31, 2010. 28 pages. CURRENT Show EN-ISO-10993-13 revision history |
$236.60 |
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EN-ISO-10993-16Biological evaluation of medical devices 2017 EDITION. Issued: JAN. 9, 2018. CURRENT Show EN-ISO-10993-16 revision history |
$236.60 |
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EN-ISO-10993-17Biological evaluation of medical devices 2023 EDITION. Issued: NOV. 23, 2023. 80 pages. CURRENT Show EN-ISO-10993-17 revision history |
$392.50 |
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EN-ISO-10993-18Biological evaluation of medical devices 2020/A1 EDITION. Issued: JULY 1, 2023. 86 pages. CURRENT Show EN-ISO-10993-18 revision history |
$372.50 |
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EN-ISO-11135-1Sterilization of health care products. Ethylene oxide Show EN-ISO-11135-1 revision history |
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EN-ISO-11137-1Sterilization of health care products. Radiation 2015/A2 EDITION. Issued: NOV. 27, 2019. 62 pages. CURRENT Show EN-ISO-11137-1 revision history |
$317.50 |
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EN-ISO-11137-2Sterilization of health care products. Radiation 2015/A1 EDITION. Issued: APRIL 21, 2023. 88 pages. CURRENT Show EN-ISO-11137-2 revision history |
$372.50 |
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EN-ISO-11137-3Sterilization of health care products. Radiation 2017 EDITION. Issued: AUG. 23, 2017. 50 pages. CURRENT Show EN-ISO-11137-3 revision history |
$300.00 |
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EN-ISO-11140-1Sterilization of health care products. Chemical indicators 2014 EDITION. Issued: NOV. 30, 2014. 44 pages. CURRENT Show EN-ISO-11140-1 revision history |
$267.50 |