Complete List of the Harmonized Standards for 93/42/eec
The Complete List of Harmonized Standards for the Medical Device Directive (Linked to Official English Language Edition)
EN-ISO-10079-3Medical suction equipment 2022 EDITION. Issued: JUNE 21, 2022. 10 pages. CURRENT Show EN-ISO-10079-3 revision history |
$150.80 |
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EN-ISO-10328Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods 2016 EDITION. Issued: JULY 31, 2016. 156 pages. CURRENT Show EN-ISO-10328 revision history |
$410.00 |
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EN-ISO-10524-1Pressure regulators for use with medical gases 2019/A1 EDITION. Issued: NOV. 3, 2023. 42 pages. CURRENT Show EN-ISO-10524-1 revision history |
$290.00 |
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EN-ISO-10524-2Pressure regulators for use with medical gases 2019 EDITION. Issued: FEB. 5, 2019. 40 pages. CURRENT Show EN-ISO-10524-2 revision history |
$267.50 |
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EN-ISO-10524-3Pressure regulators for use with medical gases 2019 EDITION. Issued: FEB. 4, 2019. 52 pages. CURRENT Show EN-ISO-10524-3 revision history |
$317.50 |
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EN-ISO-10524-4Pressure regulators for use with medical gases 2008 EDITION. Issued: FEB. 28, 2009. 42 pages. CURRENT |
$267.50 |
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EN-ISO-10535Assistive products. Hoists for the transfer of persons. Requirements and test methods 2021 EDITION. Issued: NOV. 4, 2021. 86 pages. CURRENT Show EN-ISO-10535 revision history |
$350.00 |
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EN-ISO-10555-1Intravascular catheters. Sterile and single-use catheters 2023 EDITION. Issued: DEC. 8, 2023. 52 pages. CURRENT Show EN-ISO-10555-1 revision history |
$345.00 |
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EN-ISO-10651-2Lung ventilators for medical use. Particular requirements for basic safety and essential performance Show EN-ISO-10651-2 revision history |
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EN-ISO-10651-4Lung ventilators 2023 EDITION. Issued: APRIL 6, 2023. 78 pages. CURRENT Show EN-ISO-10651-4 revision history |
$372.50 |
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EN-ISO-10651-6Lung ventilators for medical use. Particular requirements for basic safety and essential performance 2009 EDITION. Issued: JUNE 30, 2009. 42 pages. CURRENT Show EN-ISO-10651-6 revision history |
$267.50 |
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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-10993-4Biological evaluation of medical devices 2017 EDITION. Issued: MAY 25, 2017. 42 pages. CURRENT Show EN-ISO-10993-4 revision history |
$267.50 |
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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 |