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-556-1

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-980

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


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EN-ISO-11737-2

Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

2009 EDITION. Issued: MARCH 31, 2010. 28 pages. CURRENT


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$213.20

EN-12322

In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media

1999 EDITION. Issued: AUG. 15, 1999. 13 pages. CURRENT

$129.36

EN-ISO-13485

Medical devices. Quality management systems. Requirements for regulatory purposes

2016 EDITION. Issued: MARCH 1, 2016. 68 pages. CURRENT


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$270.00

EN-13532

General requirements for in vitro diagnostic medical devices for self-testing

2002 EDITION. Issued: MAY 8, 2002. 12 pages. CURRENT

$129.36

EN-13612

Performance evaluation of in vitro diagnostic medical devices

2002 EDITION. Issued: MAY 7, 2002. 18 pages. CURRENT

$150.80

EN-13640

Stability testing of in vitro diagnostic reagents


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EN-13641

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

2002 EDITION. Issued: MAY 27, 2002. 11 pages. CURRENT

$129.36

EN-13975

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

2003 EDITION. Issued: MARCH 28, 2003. 16 pages. CURRENT

$150.80

EN-14136

Use 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

$129.36

EN-14254

In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

2004 EDITION. Issued: JULY 6, 2004. 22 pages. CURRENT

$150.80

EN-14820

Single-use containers for human venous blood specimen collection

2004 EDITION. Issued: SEPT. 8, 2004. 22 pages. CURRENT

$150.80

EN-ISO-14937

Sterilization 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


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$285.00

EN-ISO-14971

Medical devices. Application of risk management to medical devices

2012 EDITION. Issued: JULY 31, 2012. 106 pages. CURRENT


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$327.50

EN-ISO-15193

In 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

$213.20

EN-ISO-15194

In 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

$213.20

EN-ISO-15197

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus

2015 EDITION. Issued: JUNE 30, 2015. 60 pages. CURRENT


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$265.00

EN-ISO-17511

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials

2003 EDITION. Issued: AUG. 19, 2003. 32 pages. CURRENT

$213.20