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-285

Sterilization. Steam sterilizers. Large sterilizers

2015/A1 EDITION. Issued: NOV. 29, 2021. 144 pages. CURRENT


Show EN-285 revision history

$420.00

EN-455-1

Medical gloves for single use


Show EN-455-1 revision history
EN-455-2

Medical gloves for single use

2024 EDITION. Issued: MAY 8, 2024. 20 pages. CURRENT


Show EN-455-2 revision history

$195.00

EN-455-3

Medical gloves for single use

2023 EDITION. Issued: DEC. 7, 2023. 48 pages. CURRENT


Show EN-455-3 revision history

$327.50

EN-455-4

Medical gloves for single use

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

$169.00

EN-556-1

Sterilization 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

EN-556-2

Sterilization 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

EN-794-1

Particular Requirements for Critical Care Ventilators - Lung Ventilators


Show EN-794-1 revision history
EN-794-3

Lung ventilators


Show EN-794-3 revision history
EN-980

Symbols for use in the labelling of medical devices


Show EN-980 revision history
EN-1041

Information supplied by the manufacturer of medical devices


Show EN-1041 revision history
EN-1060-1

Non-invasive sphygmomanometers. General requirements


Show EN-1060-1 revision history
EN-1060-2

Non-invasive sphygmomanometers


Show EN-1060-2 revision history
EN-1060-3

Non-invasive sphygmomanometers

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

$236.60

EN-1060-4

Non-invasive sphygmomanometers

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

$267.50

EN-1089-3

Transportable gas cylinders. Gas cylinder identification (excluding LPG)

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


Show EN-1089-3 revision history

$169.00

EN-1282-2

Tracheostomy tubes

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


Show EN-1282-2 revision history

$236.60

EN-1422

Sterilizers 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

EN-1618

Catheters other than intravascular catheters. Test methods for common properties


Show EN-1618 revision history
EN-1639

Dentistry. Medical devices for dentistry. Instruments

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


Show EN-1639 revision history

$169.00