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)


Sterilization. Steam sterilizers. Large sterilizers

2015 EDITION. Issued: JAN. 31, 2016. 106 pages. CURRENT

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Medical gloves for single use

2000 EDITION. Issued: DEC. 15, 2000. 8 pages. CURRENT

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Medical gloves for single use

2015 EDITION. Issued: APRIL 30, 2015. 16 pages. CURRENT

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Medical gloves for single use. Requirements and testing for biological evaluation

2015 EDITION. Issued: APRIL 30, 2015. 38 pages. CURRENT

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Medical gloves for single use

2009 EDITION. Issued: AUG. 31, 2009. 22 pages. CURRENT



Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices

2001 EDITION. Issued: DEC. 11, 2001. 12 pages. CURRENT



Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for aseptically processed medical devices

2015 EDITION. Issued: SEPT. 30, 2015. 20 pages. CURRENT

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Particular Requirements for Critical Care Ventilators - Lung Ventilators

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Lung ventilators. Particular requirements for emergency and transport ventilators

1999 EDITION. Issued: JAN. 15, 1999. 24 pages. CURRENT



Symbols for use in the labelling of medical devices - Replaced by BS-EN-ISO-15223-1

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Information supplied by the manufacturer of medical devices

2008/A1 EDITION. Issued: OCT. 15, 2013. 28 pages. CURRENT

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Non-invasive sphygmomanometers. General requirements

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Part 2: Supplementary Requirements for Mechanical Sphygomomanometers, Non-Invasive Sphygmo

1996 EDITION. Issued: JUNE 15, 1996. 20 pages. CURRENT



Non-invasive sphygmomanometers. Supplementary requirements for electro-mechanical blood pressure measuring systems

1997 EDITION. Issued: JULY 15, 1997. 18 pages. CURRENT



Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

2004 EDITION. Issued: OCT. 6, 2004. 36 pages. CURRENT



Transportable gas cylinders. Gas cylinder identification (excluding LPG). Colour coding

2011 EDITION. Issued: AUG. 31, 2011. 20 pages. CURRENT

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Tracheostomy tubes. Paediatric tubes

2005 EDITION. Issued: JAN. 1, 2005. 24 pages. CURRENT

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Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods

2014 EDITION. Issued: MAY 31, 2014. 54 pages. CURRENT

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Catheters other than intravascular catheters. Test methods for common properties

1997 EDITION. Issued: JULY 15, 1997. 14 pages. CURRENT



Dentistry. Medical devices for dentistry. Instruments

2009 EDITION. Issued: NOV. 30, 2009. 18 pages. CURRENT

Show EN-1639 revision history