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-14563Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area. Test method and requirements (phase 2, step 2) 2008 EDITION. Issued: DEC. 31, 2008. 40 pages. CURRENT |
$267.50 |
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EN-ISO-14607Non-active surgical implants. Mammary implants. Particular requirements 2018 EDITION. Issued: MAY 24, 2018. 54 pages. CURRENT Show EN-ISO-14607 revision history |
$317.50 |
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EN-ISO-14630Non-active surgical implants. General requirements 2012 EDITION. Issued: DEC. 31, 2012. 26 pages. CURRENT Show EN-ISO-14630 revision history |
$236.60 |
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EN-14683Medical face masks. Requirements and test methods 2019 EDITION. Issued: MARCH 27, 2019. 26 pages. CURRENT Show EN-14683 revision history |
$236.60 |
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EN-ISO-14889Ophthalmic optics. Spectacle lenses. Fundamental requirements for uncut finished lenses 2013/A1 EDITION. Issued: FEB. 1, 2018. 18 pages. CURRENT Show EN-ISO-14889 revision history |
$169.00 |
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EN-14931Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing 2006 EDITION. Issued: JULY 31, 2008. 42 pages. CURRENT |
$267.50 |
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EN-ISO-14937Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices 2009 EDITION. Issued: MARCH 31, 2010. 52 pages. CURRENT Show EN-ISO-14937 revision history |
$317.50 |
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EN-ISO-14971Medical devices. Application of risk management to medical devices 2019/A11 EDITION. Issued: DEC. 15, 2021. 56 pages. CURRENT Show EN-ISO-14971 revision history |
$325.00 |
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EN-ISO-15002Flow control devices for connection to a medical gas supply system 2024 EDITION. Issued: MARCH 28, 2024. 34 pages. CURRENT Show EN-ISO-15002 revision history |
$305.00 |
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EN-ISO-15004-1Ophthalmic instruments. Fundamental requirements and test methods 2020 EDITION. Issued: NOV. 30, 2020. 14 pages. CURRENT Show EN-ISO-15004-1 revision history |
$143.00 |
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EN-15424Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices Show EN-15424 revision history |
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EN-15546-1Small Bore Connectors for Liquids & Gases in Healthcare Applications, General Requirem Show EN-15546-1 revision history |
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EN-ISO-15798Ophthalmic implants. Ophthalmic viscosurgical devices 2022 EDITION. Issued: JULY 19, 2022. 32 pages. CURRENT Show EN-ISO-15798 revision history |
$249.60 |
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EN-ISO-15883-1Washer-disinfectors 2009/A1 EDITION. Issued: SEPT. 1, 2014. 84 pages. CURRENT Show EN-ISO-15883-1 revision history |
$342.50 |
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EN-ISO-15883-2Washer-disinfectors 2009 EDITION. Issued: OCT. 31, 2009. 22 pages. CURRENT Show EN-ISO-15883-2 revision history |
$169.00 |
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EN-ISO-15883-3Washer-disinfectors 2009 EDITION. Issued: OCT. 31, 2009. 24 pages. CURRENT Show EN-ISO-15883-3 revision history |
$236.60 |
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EN-ISO-15883-4Washer-disinfectors 2018 EDITION. Issued: DEC. 19, 2018. 94 pages. CURRENT Show EN-ISO-15883-4 revision history |
$342.50 |
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EN-ISO-16061Instruments for use in association with non-active surgical implants. General requirements 2021 EDITION. Issued: APRIL 6, 2021. 24 pages. CURRENT Show EN-ISO-16061 revision history |
$241.80 |
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EN-ISO-16201Technical aids for disabled persons. Environmental control systems for daily living Show EN-ISO-16201 revision history |
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EN-ISO-17510-1Sleep apnoea breathing therapy Show EN-ISO-17510-1 revision history |