In Vitro Diagnostic Medical Device (IVD)
In Vitro Diagnostic Medical Device (IVD)
Safety :
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 61010-2-101:2018 RLV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
EMC :
IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests CISPR 11:2015 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
Performance :
ISO 14971:2019 Medical devices - Application of risk management to medical devices IEC 61326-2-6:2020 RLV Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Local Standard
USA
ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2
ANSI/AAMI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
ASNI/AAMI/ISO 16142-2:2017 Medical Devices - Recognized Essential Principles Of Safety And Performance Of Medical Devices - Part 2: General Essential Principles And Additional Specific Essential Principles For All IVD Medical Devices And Guidance On The Selection Of Standards
Europe
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN 13612:2002(MAIN) Performance evaluation of in vitro diagnostic medical devices
EN 13612:2002/AC:2002 - Performance evaluation of in vitro diagnostic medical devices
EN ISO 17511:2021(MAIN) In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
EN ISO 23640:2015(MAIN) In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
EN 13532:2002(MAIN) General requirements for in vitro diagnostic medical devices for self-testing
EN 61010-2-101:2017(MAIN) Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
EN 60601-1-2:2015(MAIN) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN IEC 61326-2-6:2021(MAIN) Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
China
GB 9706.1: General requirements for safety of medical electrical equipment
GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment
GB/T 19702-2021 - In Vitro Diagnostic Medical Devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
GB/T 21415-2008 - In Vitro Diagnostic Medical Devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
Japan
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
JIS Q 14971-1:2001 Medical devices - Risk management Part 1: Application of risk analysis
JIS T 14971:2003 Medical devices - Application of risk management to medical devices
JIS T 14971:2012 Medical devices - Application of risk management to medical devices
Korea
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
KS C IEC60601-1-2: Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
KS P ISO16142-2: Medical Devices — Essential Principles for Safety and Performance of Medical Devices — Part 2: General Essential Principles for IVD Medical Devices and Additional Special Principles and Guidance on the Selection of Standards
Taiwan
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CNS 15037:2017 - In vitro diagnostic medical devices - Quality management system - Requirements for regulatory purposes
CNS 15406:2015 - In vitro diagnostic medical devices - Validation of user quality control procedures - Requirements
CNS 15500:2013 - In vitro diagnostic medical devices - Validation of nucleic acid extraction and purification processes and procedures - Requirements
CNS 15729:2011 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
Brasil
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ANBT NBRNM319 DE 08/2007 Medical laboratories - Instructions for use in vitro diagnostic instruments for professional use
ABNT NBRNM-ISO15198 DE 05/2008 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ABNT NBR16075 DE 07/2012 In vitro use diagnostic — Laboratories competence and organization of test products conformity assessment — General requirements
Mexico
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
NOM-241-SSA1-2012 Goods and services. In vitro diagnostic medical devices. Safety and efficacy specifications and test methods.
Argentina
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IRAM-NM 321 Clinical analysis laboratories. Stability study of in vitro diagnostic reagents. Requirements for manufacturers.
IRAM-NM 319 Clinical analysis laboratories. Instructions for use of in vitro diagnostic instruments for professional use.
IRAM 80102 Clinical analysis. Requirements for the labeling of reagents for use in in vitro diagnostics for professional use.
IRAM-ISO 15193 Medical devices for in vitro diagnostic use. Measurement of magnitudes in samples of biological origin. Requirements for the content and presentation of reference measurement procedures.
Australia
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
AS/NZS ISO 15189:2012 Medical laboratories - Requirements for quality and competence
South Africa
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
SANS 14971:2008 (Ed. 2.00): Medical devices - Application of risk management to medical devices
Saudi Arabia
Safety :
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 61010-2-101:2018 RLV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
EMC :
IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests CISPR 11:2015 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
Performance :
ISO 14971:2019 Medical devices - Application of risk management to medical devices IEC 61326-2-6:2020 RLV Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Local Standard
USA
ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2
ANSI/AAMI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
ASNI/AAMI/ISO 16142-2:2017 Medical Devices - Recognized Essential Principles Of Safety And Performance Of Medical Devices - Part 2: General Essential Principles And Additional Specific Essential Principles For All IVD Medical Devices And Guidance On The Selection Of Standards
Europe
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN 13612:2002(MAIN) Performance evaluation of in vitro diagnostic medical devices
EN 13612:2002/AC:2002 - Performance evaluation of in vitro diagnostic medical devices
EN ISO 17511:2021(MAIN) In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
EN ISO 23640:2015(MAIN) In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
EN 13532:2002(MAIN) General requirements for in vitro diagnostic medical devices for self-testing
EN 61010-2-101:2017(MAIN) Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
EN 60601-1-2:2015(MAIN) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN IEC 61326-2-6:2021(MAIN) Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
China
GB 9706.1: General requirements for safety of medical electrical equipment
GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment
GB/T 19702-2021 - In Vitro Diagnostic Medical Devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
GB/T 21415-2008 - In Vitro Diagnostic Medical Devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
Japan
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
JIS Q 14971-1:2001 Medical devices - Risk management Part 1: Application of risk analysis
JIS T 14971:2003 Medical devices - Application of risk management to medical devices
JIS T 14971:2012 Medical devices - Application of risk management to medical devices
Korea
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
KS C IEC60601-1-2: Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
KS P ISO16142-2: Medical Devices — Essential Principles for Safety and Performance of Medical Devices — Part 2: General Essential Principles for IVD Medical Devices and Additional Special Principles and Guidance on the Selection of Standards
Taiwan
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CNS 15037:2017 - In vitro diagnostic medical devices - Quality management system - Requirements for regulatory purposes
CNS 15406:2015 - In vitro diagnostic medical devices - Validation of user quality control procedures - Requirements
CNS 15500:2013 - In vitro diagnostic medical devices - Validation of nucleic acid extraction and purification processes and procedures - Requirements
CNS 15729:2011 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
Brasil
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ANBT NBRNM319 DE 08/2007 Medical laboratories - Instructions for use in vitro diagnostic instruments for professional use
ABNT NBRNM-ISO15198 DE 05/2008 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ABNT NBR16075 DE 07/2012 In vitro use diagnostic — Laboratories competence and organization of test products conformity assessment — General requirements
Mexico
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
NOM-241-SSA1-2012 Goods and services. In vitro diagnostic medical devices. Safety and efficacy specifications and test methods.
Argentina
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IRAM-NM 321 Clinical analysis laboratories. Stability study of in vitro diagnostic reagents. Requirements for manufacturers.
IRAM-NM 319 Clinical analysis laboratories. Instructions for use of in vitro diagnostic instruments for professional use.
IRAM 80102 Clinical analysis. Requirements for the labeling of reagents for use in in vitro diagnostics for professional use.
IRAM-ISO 15193 Medical devices for in vitro diagnostic use. Measurement of magnitudes in samples of biological origin. Requirements for the content and presentation of reference measurement procedures.
Australia
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
AS/NZS ISO 15189:2012 Medical laboratories - Requirements for quality and competence
South Africa
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
SANS 14971:2008 (Ed. 2.00): Medical devices - Application of risk management to medical devices
Saudi Arabia
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SASO IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GSO EN 13532:2021 EN 13532:2002 Gulf Standard General Requirements For In Vitro Diagnostic Medical Devices For Self-Testing
GSO ISO 20916:2021 In Vitro Diagnostic Medical Devices — Clinical Performance Studies Using Specimens From Human Subjects — Good Study Practice
EAEU
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GOST R IEC 61326-2-6-2014 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment
GOST IEC 61010-2-101-2013 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
GOST R 70393-2022 IVD medical devices. Preparation, manufacture, storage and testing of culture media
SASO IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GSO EN 13532:2021 EN 13532:2002 Gulf Standard General Requirements For In Vitro Diagnostic Medical Devices For Self-Testing
GSO ISO 20916:2021 In Vitro Diagnostic Medical Devices — Clinical Performance Studies Using Specimens From Human Subjects — Good Study Practice
EAEU
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GOST R IEC 61326-2-6-2014 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment
GOST IEC 61010-2-101-2013 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
GOST R 70393-2022 IVD medical devices. Preparation, manufacture, storage and testing of culture media
