Complete list of the Harmonized Standards for 98/79/ec
List of European Harmonized Standards For Directive 98/79/EC for In vitro diagnostic medical devices (with links to the Official English Language Edition of each)
EN-556-1Sterilization 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 |
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EN-556-2Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' 2024 EDITION. Issued: NOV. 8, 2024. 22 pages. CURRENT Show EN-556-2 revision history |
$195.00 |
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EN-980Symbols for use in the labelling of medical devices Show EN-980 revision history |
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EN-ISO-11737-2Sterilization of health care products. Microbiological methods 2020 EDITION. Issued: MAY 19, 2020. 28 pages. CURRENT Show EN-ISO-11737-2 revision history |
$267.50 |
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EN-12322In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media 1999 EDITION. Issued: AUG. 15, 1999. 13 pages. CURRENT |
$143.00 |
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EN-ISO-13485Medical devices. Quality management systems. Requirements for regulatory purposes 2016/A11 EDITION. Issued: SEPT. 30, 2021. 90 pages. CURRENT Show EN-ISO-13485 revision history |
$350.00 |
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EN-13532General requirements for in vitro diagnostic medical devices for self-testing 2002 EDITION. Issued: MAY 8, 2002. 12 pages. CURRENT |
$143.00 |
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EN-13612Performance evaluation of in vitro diagnostic medical devices 2002 EDITION. Issued: MAY 7, 2002. 18 pages. CURRENT |
$169.00 |
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EN-13640Stability testing of in vitro diagnostic reagents Show EN-13640 revision history |
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EN-13641Elimination or reduction of risk of infection related to in vitro diagnostic reagents 2002 EDITION. Issued: MAY 27, 2002. 11 pages. CURRENT |
$143.00 |
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EN-13975Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects 2003 EDITION. Issued: MARCH 28, 2003. 16 pages. CURRENT |
$169.00 |
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EN-14136Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures 2004 EDITION. Issued: MAY 26, 2004. 14 pages. CURRENT |
$143.00 |
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EN-14254In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans Show EN-14254 revision history |
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EN-14820Single-use containers for human venous blood specimen collection Show EN-14820 revision history |
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EN-ISO-14937Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices 2009 EDITION. Issued: MARCH 31, 2010. 52 pages. CURRENT Show EN-ISO-14937 revision history |
$317.50 |
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EN-ISO-14971Medical devices. Application of risk management to medical devices 2019/A11 EDITION. Issued: DEC. 15, 2021. 56 pages. CURRENT Show EN-ISO-14971 revision history |
$325.00 |
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EN-ISO-15193In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures 2009 EDITION. Issued: MAY 31, 2009. 30 pages. CURRENT |
$236.60 |
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EN-ISO-15194In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation 2009 EDITION. Issued: MAY 31, 2009. 26 pages. CURRENT |
$236.60 |
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EN-ISO-15197In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 2015 EDITION. Issued: JUNE 30, 2015. 60 pages. CURRENT Show EN-ISO-15197 revision history |
$317.50 |
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EN-ISO-17511In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples 2021 EDITION. Issued: JULY 6, 2021. 32 pages. CURRENT Show EN-ISO-17511 revision history |
$335.00 |