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-22610

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Test method to determine the resistance to wet bacterial penetration

2006 EDITION. Issued: JAN. 31, 2007. 26 pages. CURRENT

$236.60

EN-ISO-22612

Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration

2005 EDITION. Issued: MARCH 24, 2005. 18 pages. CURRENT

$169.00

EN-ISO-22675

Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods

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


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$365.00

EN-ISO-23328-1

Breathing system filters for anaesthetic and respiratory use

2008 EDITION. Issued: MAY 30, 2008. 22 pages. CURRENT

$169.00

EN-ISO-23328-2

Breathing system filters for anaesthetic and respiratory use

2009 EDITION. Issued: APRIL 30, 2009. 16 pages. CURRENT


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$169.00

EN-ISO-23747

Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

2015 EDITION. Issued: AUG. 31, 2015. 42 pages. CURRENT


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$267.50

EN-ISO-25539-1

Cardiovascular implants. Endovascular devices

2017 EDITION. Issued: MARCH 31, 2017. 142 pages. CURRENT


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$392.50

EN-ISO-25539-2

Cardiovascular implants. Endovascular devices

2020 EDITION. Issued: OCT. 6, 2020. 126 pages. CURRENT


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$392.50

EN-ISO-26782

Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans

2009 EDITION. Issued: OCT. 31, 2009. 38 pages. CURRENT

$267.50

EN-27740

Specification for dimensions of surgical scalpels with detatchable blades

1992 EDITION. Issued: OCT. 15, 1992. 14 pages. CURRENT

$143.00

EN-60118-13

Electroacoustics. Hearing aids

RENUMBERED BY BS-EN-IEC-60118-13. Issued: APRIL 6, 2020. CURRENT


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EN-60522

Determination of the permanent filtration of X-ray tube assemblies

1999 EDITION. Issued: JAN. 1, 1999. CURRENT

$143.00

EN-60580

Dose area product meters

RENUMBERED BY BS-EN-IEC-60580. Issued: APRIL 6, 2020. CURRENT


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EN-60601-1

Medical electrical equipment

2006/A2 EDITION. Issued: NOV. 2, 2021. 458 pages. CURRENT


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$564.00

EN-60601-1-1

Medical electrical equipment. General requirements for safety


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EN-60601-1-2

Medical electrical equipment

2015/A1 EDITION. Issued: MARCH 24, 2021. 116 pages. CURRENT


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$372.50

EN-60601-1-3

Medical electrical equipment

2008/A2 EDITION. Issued: MARCH 10, 2021. 64 pages. CURRENT


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$325.00

EN-60601-1-4

Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electrical medical systems


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EN-60601-1-6

Medical electrical equipment

2010/A2 EDITION. Issued: AUG. 13, 2021. 26 pages. CURRENT


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$241.80

EN-60601-1-8

Medical electrical equipment

2007/A2 EDITION. Issued: AUG. 20, 2021. 134 pages. CURRENT


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$420.00