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-13726-2Test methods for primary wound dressings Show EN-13726-2 revision history |
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EN-13727Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Test method and requirements (phase 2, step 1) 2012/A2 EDITION. Issued: NOV. 1, 2015. CURRENT Show EN-13727 revision history |
$317.50 |
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EN-13795-1Surgical clothing and drapes. Requirements and test methods 2019 EDITION. Issued: APRIL 12, 2019. 36 pages. CURRENT Show EN-13795-1 revision history |
$278.20 |
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EN-13795-2Surgical clothing and drapes. Requirements and test methods 2019 EDITION. Issued: APRIL 12, 2019. 32 pages. CURRENT Show EN-13795-2 revision history |
$236.60 |
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EN-13795-3Surgical Drapes, Gowns & Clean Air Suits, Used as Medical Devices for Patients, Clinic Show EN-13795-3 revision history |
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EN-13824Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements Show EN-13824 revision history |
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EN-13867Concentrates for haemodialysis and related therapies Show EN-13867 revision history |
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EN-13976-1Rescue systems. Transportation of incubators 2018 EDITION. Issued: JULY 5, 2018. 16 pages. CURRENT Show EN-13976-1 revision history |
$169.00 |
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EN-13976-2Rescue systems. Transportation of incubators 2018 EDITION. Issued: JULY 4, 2018. 14 pages. CURRENT Show EN-13976-2 revision history |
$143.00 |
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EN-14079Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze 2003 EDITION. Issued: MAY 13, 2003. 22 pages. CURRENT |
$169.00 |
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EN-14139Ophthalmic optics. Specifications for ready-to-wear spectacles 2010 EDITION. Issued: JUNE 30, 2010. 10 pages. CURRENT Show EN-14139 revision history |
$143.00 |
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EN-ISO-14155-1Clinical investigation of medical devices for human subjects Show EN-ISO-14155-1 revision history |
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EN-ISO-14155-2Clinical investigation of medical devices for human subjects Show EN-ISO-14155-2 revision history |
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EN-ISO-14160Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices 2021 EDITION. Issued: JULY 5, 2021. 46 pages. CURRENT Show EN-ISO-14160 revision history |
$327.50 |
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EN-14180Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing 2014 EDITION. Issued: MAY 31, 2014. 66 pages. CURRENT Show EN-14180 revision history |
$317.50 |
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EN-14348Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1) 2005 EDITION. Issued: FEB. 9, 2005. 40 pages. CURRENT |
$267.50 |
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EN-ISO-14408Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information 2016 EDITION. Issued: MARCH 31, 2016. 20 pages. CURRENT Show EN-ISO-14408 revision history |
$169.00 |
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EN-ISO-14534Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements 2015 EDITION. Issued: FEB. 28, 2015. 22 pages. CURRENT Show EN-ISO-14534 revision history |
$169.00 |
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EN-14561Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2) 2006 EDITION. Issued: JUNE 30, 2006. 40 pages. CURRENT |
$267.50 |
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EN-14562Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2) 2006 EDITION. Issued: JUNE 30, 2006. 44 pages. CURRENT |
$267.50 |