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Medical Conformity Assessment

Conformity Assessment Standards serve to provide a reference against which organizations can measure themselves as well as guiding third parties performing conformity assessment with a consistent and fair metric. The ISO/IEC 17000 series of standards is a broadly applicable conformity assessment guide that addresses impartiality, confidentiality, complaints and appeals, information disclosure, and the use of management systems, as well as a strong focus on requirements for bodies providing audit and certification of management systems. Conformity and certification of persons, products, processes, and services is a key element as well. Together, the ISO/IEC 17000 series of standards provides a thorough guide to conformity assessment for both those being assessed and those doing the assessing. These standards are related to conformity in an medical setting.

ISO 15197:2013

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.

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ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to — protect the rights, safety and well-being of human subjects, — ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, — define the responsibilities of the sponsor and principal investigator, and — assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply. NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

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ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package

Historical Package

The ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package defines procedures and requirements for the conduct and performance of clinical investigations of medical devices under normal clinical use. This package aims to protect human subjects, ensure the scientific conduct of the clinical investigation and assist monitors, investigators, ethic committees and all bodies involved in the conformity assessment of medical devices. This package includes ANSI/AAMI/ISO 14155-1:2003 and ANSI/AAMI/ISO 14155-2:2003.

ISO 17593:2007

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

ISO 17593:2007 specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. ISO 17593:2007 pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR). ISO 17593:2007 is applicable to manufacturers of such systems and those other organizations (e.g., regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. ISO 17593:2007 does not pertain to in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers, provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or address the medical aspects of oral anticoagulation therapy.

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ISO 16142-1:2016

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

ISO 16142:2016, 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 part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). ISO 16142:2016also 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 medical devices other than IVD medical devices. Future ISO 16142 2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of 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. ISO 16142:2016 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.

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