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-285Sterilization. Steam sterilizers. Large sterilizers 2015/A1 EDITION. Issued: NOV. 29, 2021. 144 pages. CURRENT Show EN-285 revision history |
$420.00 |
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EN-455-1Medical gloves for single use Show EN-455-1 revision history |
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EN-455-2Medical gloves for single use 2024 EDITION. Issued: MAY 8, 2024. 20 pages. CURRENT Show EN-455-2 revision history |
$195.00 |
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EN-455-3Medical gloves for single use 2023 EDITION. Issued: DEC. 7, 2023. 48 pages. CURRENT Show EN-455-3 revision history |
$327.50 |
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EN-455-4Medical gloves for single use 2009 EDITION. Issued: AUG. 31, 2009. 22 pages. CURRENT |
$169.00 |
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EN-556-1Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' 2024 EDITION. Issued: JULY 3, 2024. 20 pages. CURRENT Show EN-556-1 revision history |
$195.00 |
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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-794-1Particular Requirements for Critical Care Ventilators - Lung Ventilators Show EN-794-1 revision history |
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EN-794-3Lung ventilators Show EN-794-3 revision history |
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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-1060-1Non-invasive sphygmomanometers. General requirements Show EN-1060-1 revision history |
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EN-1060-2Non-invasive sphygmomanometers Show EN-1060-2 revision history |
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EN-1060-3Non-invasive sphygmomanometers 1997 EDITION. Issued: JULY 15, 1997. 18 pages. CURRENT |
$236.60 |
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EN-1060-4Non-invasive sphygmomanometers 2004 EDITION. Issued: OCT. 6, 2004. 36 pages. CURRENT |
$267.50 |
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EN-1089-3Transportable gas cylinders. Gas cylinder identification (excluding LPG) 2011 EDITION. Issued: AUG. 31, 2011. 20 pages. CURRENT Show EN-1089-3 revision history |
$169.00 |
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EN-1282-2Tracheostomy tubes 2005 EDITION. Issued: JAN. 1, 2005. 24 pages. CURRENT Show EN-1282-2 revision history |
$236.60 |
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EN-1422Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods 2014 EDITION. Issued: MAY 31, 2014. 54 pages. CURRENT Show EN-1422 revision history |
$317.50 |
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EN-1618Catheters other than intravascular catheters. Test methods for common properties Show EN-1618 revision history |
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EN-1639Dentistry. Medical devices for dentistry. Instruments 2009 EDITION. Issued: NOV. 30, 2009. 18 pages. CURRENT Show EN-1639 revision history |
$169.00 |