M/252 - In vitro diagnostic med. dev.

IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of the document with respect to test levels and documentation.

IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE. BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE. NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020 NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE. This edition includes the following significant technical changes with respect to the previous edition: - Update of the document with respect to test levels and documentation.

The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- adaptation of changes introduced by Amendment 1 of IEC 61010-1;
- added tolerance for stability of AC voltage test equipment to Clause 6.
This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).

The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).

IEC 61326-2-6:2020 is available as IEC 61326-2-6:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 61326-2-6:2020 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.

IEC 61326-2-6:2020 is available as IEC 61326-2-6:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61326-2-6:2020 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes:
- excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment;
- updated Biohazard and Lot symbols in Table 1 in Clause 5;
- added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5;
- added requirement for gas or liquid markings and ratings to Clause 5;
- added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5;
- added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5;
- added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5;
- added requirement for OPERATOR maintenance instructions to Clause 7;
- added requirements for sample zones and loading zones to Clause 7;
- excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8;
- added requirement for biohazard marking to Clause 13;
- added requirement for interlock systems containing electric/electronic or programmable components to Clause 15;
- added informative reference to Usability standard IEC 62366 to Clause 16;
- replaced Clause 17 with requirements of ISO 14971 for RISK assessment.
- Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.

IEC 61326-2-6:2012 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. This second edition cancels and replaces the first edition published in 2005 and constitutes a technical revision. It includes the following significant technical change: update of the document with respect to IEC 61326-1:2012.

IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes: - excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment; - updated Biohazard and Lot symbols in Table 1 in Clause 5; - added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5; - added requirement for gas or liquid markings and ratings to Clause 5; - added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5; - added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5; - added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5; - added requirement for OPERATOR maintenance instructions to Clause 7; - added requirements for sample zones and loading zones to Clause 7; - excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8; - added requirement for biohazard marking to Clause 13; - added requirement for interlock systems containing electric/electronic or programmable components to Clause 15; - added informative reference to Usability standard IEC 62366 to Clause 16; - replaced Clause 17 with requirements of ISO 14971 for RISK assessment. - Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.

IEC 61326-2-6:2012 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. This second edition cancels and replaces the first edition published in 2005 and constitutes a technical revision. It includes the following significant technical change: update of the document with respect to IEC 61326-1:2012.