98/79/EC

In vitro diagnostic medical devices

This web page provides you with updated information on the European standard supporting the implementation of EU Directives and regulations. It provides, on one hand the information corresponding to the real-time status of the standards provided by CEN and CENELEC and, on the other hand, provides updated information about the status of the standards in support of the European legislation. It may happen that a standard is withdrawn by the standardisation body and remains applicable in the context of the EU legislation, unless the reference is withdrawn from the official journal.

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6 - Draft standards 58 - View all published standards related to this directive 99 - Withdrawn standards

Harmonised Standards or standards supporting the application of the EU legislation

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

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

90.93 Standard confirmed

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

90.93 Standard confirmed

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

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

90.93 Standard confirmed

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Performance evaluation of in vitro diagnostic medical devices

90.93 Standard confirmed

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

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

90.93 Standard confirmed

C 280 Official journal reference
Nov 21, 2003 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

90.92 Standard to be revised

C 173 Official journal reference
May 13, 2016 Official journal publication date

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

99.60 Withdrawal effective

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

60.60 Standard published

C 173 Official journal reference
May 13, 2016 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

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 (ISO 14937:2000)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

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

60.60 Standard published

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

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

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

90.93 Standard confirmed

C 280 Official journal reference
Nov 21, 2003 Official journal publication date

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Stability testing of in vitro diagnostic reagents

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Single-use containers for human venous blood specimen collection

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Instructions for use for in vitro diagnostic instruments for self-testing

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Instructions for use for in vitro diagnostic instruments for professional use

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

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

90.93 Standard confirmed

C 288 Official journal reference
Oct 9, 1999 Official journal publication date

Requirements for marking of in vitro diagnostic instruments

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

99.60 Withdrawal effective

C 227 Official journal reference
Aug 10, 1999 Official journal publication date

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

99.60 Withdrawal effective

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

60.60 Standard published

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

60.60 Standard published

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

60.60 Standard published

C 242 Official journal reference
Aug 19, 2011 Official journal publication date

Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

99.60 Withdrawal effective

C 22 Official journal reference
Jan 24, 2013 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

90.92 Standard to be revised

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

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 (ISO 14937:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

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 (ISO 14937:2009)

60.60 Standard published

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

90.93 Standard confirmed

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

90.92 Standard to be revised

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

60.60 Standard published

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013)

99.60 Withdrawal effective

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

60.60 Standard published

C 123 Official journal reference
Apr 27, 2012 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 319 Official journal reference
Nov 14, 2001 Official journal publication date

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

99.60 Withdrawal effective

C 16 Official journal reference
Jan 18, 2011 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Performance evaluation of in vitro diagnostic medical devices

60.60 Standard published

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

99.60 Withdrawal effective

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

C 389 Official journal reference
Nov 17, 2017 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

99.60 Withdrawal effective

C 262 Official journal reference
Aug 30, 2012 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

99.60 Withdrawal effective

C 183 Official journal reference
Jul 7, 2010 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

99.60 Withdrawal effective

C 41 Official journal reference
Feb 19, 2009 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)

99.60 Withdrawal effective

C 293 Official journal reference
Dec 2, 2009 Official journal publication date

Graphical symbols for use in the labelling of medical devices

99.60 Withdrawal effective

C 83 Official journal reference
Apr 2, 2004 Official journal publication date

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)

99.60 Withdrawal effective

C 103 Official journal reference
Apr 28, 2005 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2000)

99.60 Withdrawal effective

C 182 Official journal reference
Jul 31, 2002 Official journal publication date

Medical devices - Application of usability engineering to medical devices

99.60 Withdrawal effective

C 22/03 Official journal reference
Jan 24, 2013 Official journal publication date

Medical device software - Software life-cycle processes

60.60 Standard published

C 14 Official journal reference
Jan 16, 2015 Official journal publication date

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

99.60 Withdrawal effective

C 22/03 Official journal reference
Jan 24, 2013 Official journal publication date

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

99.60 Withdrawal effective

C 22/03 Official journal reference
Jan 24, 2013 Official journal publication date

Medical device software - Software life-cycle processes

60.60 Standard published

C 22/03 Official journal reference
Jan 24, 2013 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 90 Official journal reference
Mar 25, 2020 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

L 90 Official journal reference
Mar 25, 2020 Official journal publication date

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

60.60 Standard published

L 129 Official journal reference
Apr 15, 2021 Official journal publication date

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

60.60 Standard published

L 90 Official journal reference
Mar 25, 2020 Official journal publication date

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

60.60 Standard published

L 90 Official journal reference
Mar 25, 2020 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 90 Official journal reference
Mar 25, 2020 Official journal publication date