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

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.