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 d

Standard No.

ISO 16142-2:2017

Release Date

2017

Published By

International Organization for Standardization (ISO)

Latest

ISO 16142-2:2017

Scope

This document, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This document identifies and describes the six general essential principles of safety and performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic). This document also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to IVD medical devices. NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others. This document is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.

ISO 16142-2:2017 Referenced Document

• EN 13532 General requirements for in vitro diagnostic medical devices for self-testing
• EN 13612 Performance evaluation of in vitro diagnostic medical devices
• EN 13641 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
• EN 14136 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
• IEC 60068 Basic climatic and mechanical robustness testing procedure for components
• IEC 60812 Failure modes and effects analysis (FMEA and FMECA)*， 2018-08-01 Update
• IEC 60878 Graphical symbols for electrical equipment in medical practice
• IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment*， 2020-10-28 Update
• IEC 62304 Medical device software - Software life cycle processes
• IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices*， 2024-04-22 Update
• IEC 62471 Photobiological safety of lamps and lamp systems
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release
• ISO 13485 *， 2018-05-15 Update
• ISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• 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
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 15193 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
• 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
• ISO 15195 Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures*， 2018-12-20 Update
• ISO 15197 In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
• ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
• ISO 15882 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
• ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples*， 2020-04-24 Update
• ISO 17593 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy*， 2022-03-11 Update
• ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
• ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment*， 2018-07-31 Update
• ISO 20857 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 23640 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
• ISO 25424 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment*， 2022-01-12 Update
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]*， 2017-11-01 Update
• ISO/TR 24971 Medical devices - Guidance on the application of ISO 14971*， 2020-07-01 Update
• ISO/TS 13004 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>

ISO 16142-2:2017 history

• 2017 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 d