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-7396-1

Medical gas pipeline systems

2016/A1 EDITION. Issued: FEB. 5, 2019. 190 pages. CURRENT


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$427.50

EN-ISO-7396-2

Medical gas pipeline systems

2007 EDITION. Issued: MAY 31, 2007. 58 pages. CURRENT

$317.50

EN-ISO-7439

Copper-bearing contraceptive intrauterine devices. Requirements and tests

2023 EDITION. Issued: APRIL 25, 2023. 28 pages. CURRENT


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$257.40

EN-ISO-7886-3

Sterile hypodermic syringes for single use

2020 EDITION. Issued: MAY 27, 2020. 24 pages. CURRENT


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$236.60

EN-ISO-7886-4

Sterile hypodermic syringes for single use

2019 EDITION. Issued: MARCH 6, 2019. 20 pages. CURRENT


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$169.00

EN-ISO-8185

Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems

2009 EDITION. Issued: JULY 31, 2009. 66 pages. CURRENT


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$317.50

EN-ISO-8359

Oxygen concentrators for medical use. Safety requirements


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EN-ISO-8536-4

Infusion equipment for medical use

2020 EDITION. Issued: FEB. 4, 2020. 26 pages. CURRENT


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$236.60

EN-ISO-8835-2

Inhalational anaesthesia systems


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EN-ISO-8835-3

Inhalational anaesthesia systems. Transfer and receiving systems of active anaesthetic gas scavenging systems


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EN-ISO-8835-4

Inhalational anaesthesia systems


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EN-ISO-8835-5

Inhalational anaesthesia systems


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EN-ISO-9170-1

Terminal units for medical gas pipeline systems

2020 EDITION. Issued: JUNE 22, 2020. 34 pages. CURRENT


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$267.50

EN-ISO-9170-2

Terminal units for medical gas pipeline systems

2008 EDITION. Issued: AUG. 29, 2008. 34 pages. CURRENT

$267.50

EN-ISO-9360-1

Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans

2009 EDITION. Issued: MAY 31, 2009. 30 pages. CURRENT


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$236.60

EN-ISO-9360-2

Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans

2009 EDITION. Issued: MAY 31, 2009. 16 pages. CURRENT


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$169.00

EN-ISO-9713

Neurosurgical implants. Self-closing intracranial aneurysm clips

2009 EDITION. Issued: OCT. 31, 2009. 18 pages. CURRENT


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$169.00

EN-ISO-9919

Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use


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EN-ISO-10079-1

Medical suction equipment

2022 EDITION. Issued: APRIL 6, 2022. 12 pages. CURRENT


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$150.80

EN-ISO-10079-2

Medical suction equipment

2022 EDITION. Issued: JUNE 13, 2022. 10 pages. CURRENT


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$150.80