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


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$327.50

EN-455-1

Medical gloves for single use. Requirements and testing for freedom from holes

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


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$129.36

EN-455-2

Medical gloves for single use. Requirements and testing for physical properties

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


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$140.40

EN-455-3

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

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


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$226.20

EN-455-4

Medical gloves for single use. Requirements and testing for shelf life determination

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

$150.80

EN-556-1

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

$129.36

EN-556-2

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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$140.40

EN-794-1

Particular Requirements for Critical Care Ventilators - Lung Ventilators


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EN-794-3

Lung ventilators. Particular requirements for emergency and transport ventilators

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

$270.00

EN-980

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


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EN-1041

Information supplied by the manufacturer of medical devices

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


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$213.20

EN-1060-1

Non-invasive sphygmomanometers. General requirements


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EN-1060-2

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

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

$213.20

EN-1060-3

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

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

$213.20

EN-1060-4

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

$247.00

EN-1089-3

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

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


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$150.80

EN-1282-2

Tracheostomy tubes. Paediatric tubes

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


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$213.20

EN-1422

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

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


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$285.00

EN-1618

Catheters other than intravascular catheters. Test methods for common properties

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

$129.36

EN-1639

Dentistry. Medical devices for dentistry. Instruments

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


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$150.80