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-17510-2Sleep apnoea breathing therapy 2009 EDITION. Issued: APRIL 30, 2009. 40 pages. CURRENT Show EN-ISO-17510-2 revision history |
$267.50 |
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EN-ISO-17664Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices Show EN-ISO-17664 revision history |
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EN-ISO-17665-1Sterilization of health care products. Moist heat 2006 EDITION. Issued: SEPT. 29, 2006. 52 pages. CURRENT |
$317.50 |
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EN-ISO-18777Transportable liquid oxygen systems for medical use. Particular requirements 2009 EDITION. Issued: JULY 31, 2009. 40 pages. CURRENT Show EN-ISO-18777 revision history |
$267.50 |
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EN-ISO-18778Respiratory equipment. Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors 2022 EDITION. Issued: NOV. 1, 2022. 68 pages. CURRENT Show EN-ISO-18778 revision history |
$335.00 |
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EN-ISO-18779Medical devices for conserving oxygen and oxygen mixtures. Particular requirements Show EN-ISO-18779 revision history |
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EN-ISO-19054Rail systems for supporting medical equipment 2006/A1 EDITION. Issued: JAN. 1, 2017. 32 pages. CURRENT Show EN-ISO-19054 revision history |
$236.60 |
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EN-20594-1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. General requirements Show EN-20594-1 revision history |
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EN-ISO-21171Medical gloves. Determination of removable surface powder 2006 EDITION. Issued: JUNE 30, 2006. 22 pages. CURRENT |
$169.00 |
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EN-ISO-21534Non-active surgical implants. Joint replacement implants. Particular requirements 2009 EDITION. Issued: OCT. 31, 2009. 24 pages. CURRENT Show EN-ISO-21534 revision history |
$236.60 |
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EN-ISO-21535Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants 2009/A1 EDITION. Issued: JAN. 1, 2017. 20 pages. CURRENT Show EN-ISO-21535 revision history |
$169.00 |
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EN-ISO-21536Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants 2009/A1 EDITION. Issued: APRIL 1, 2014. 16 pages. CURRENT Show EN-ISO-21536 revision history |
$169.00 |
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EN-ISO-21647Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors Show EN-ISO-21647 revision history |
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EN-ISO-21649Needle-free injection systems for medical use. Requirements and test methods 2023 EDITION. Issued: FEB. 10, 2023. 48 pages. CURRENT Show EN-ISO-21649 revision history |
$327.50 |
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EN-ISO-21969High-pressure flexible connections for use with medical gas systems 2009 EDITION. Issued: MARCH 31, 2010. 22 pages. CURRENT Show EN-ISO-21969 revision history |
$169.00 |
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EN-ISO-21987Ophthalmic optics. Mounted spectacle lenses 2017 EDITION. Issued: SEPT. 15, 2017. 30 pages. CURRENT Show EN-ISO-21987 revision history |
$236.60 |
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EN-ISO-22442-1Medical devices utilizing animal tissues and their derivatives 2020 EDITION. Issued: DEC. 14, 2020. 38 pages. CURRENT Show EN-ISO-22442-1 revision history |
$267.50 |
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EN-ISO-22442-2Medical devices utilizing animal tissues and their derivatives 2020 EDITION. Issued: DEC. 14, 2020. 28 pages. CURRENT Show EN-ISO-22442-2 revision history |
$236.60 |
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EN-ISO-22442-3Medical devices utilizing animal tissues and their derivatives 2007 EDITION. Issued: FEB. 29, 2008. 34 pages. CURRENT |
$267.50 |
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EN-ISO-22523External limb prostheses and external orthoses. Requirements and test methods 2006 EDITION. Issued: OCT. 31, 2006. 98 pages. CURRENT |
$342.50 |