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'

2001 EDITION. Issued: DEC. 11, 2001. 12 pages. CURRENT

$143.00

EN-556-2

Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'

2015 EDITION. Issued: SEPT. 30, 2015. 20 pages. CURRENT


Show EN-556-2 revision history

$169.00

EN-980

Symbols for use in the labelling of medical devices


Show EN-980 revision history
EN-ISO-11737-2

Sterilization of health care products. Microbiological methods

2020 EDITION. Issued: MAY 19, 2020. 28 pages. CURRENT


Show EN-ISO-11737-2 revision history

$267.50

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

$143.00

EN-ISO-13485

Medical 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

EN-13532

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

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

$143.00

EN-13612

Performance evaluation of in vitro diagnostic medical devices

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

$169.00

EN-13640

Stability testing of in vitro diagnostic reagents


Show EN-13640 revision history
EN-13641

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

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

$143.00

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

$169.00

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

$143.00

EN-14254

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


Show EN-14254 revision history
EN-14820

Single-use containers for human venous blood specimen collection


Show EN-14820 revision history
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


Show EN-ISO-14937 revision history

$317.50

EN-ISO-14971

Medical 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

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

$236.60

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

$236.60

EN-ISO-15197

In 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

EN-ISO-17511

In 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