EN ISO 1942:2020/prA1

Overview

EN ISO 1942:2020/prA1 is an important amendment to the international standard ISO 1942:2020, specifically focusing on dentistry vocabulary. This amendment, titled "Dentistry - Vocabulary - Amendment 1: Definitions for types of tests used in standards development," introduces precise definitions related to various tests utilized during the development of standards within the dental sector. Published by CEN and coordinated by ISO/TC 106/SC 3, this document plays a crucial role in harmonizing terminology for dental professionals, manufacturers, and standardization bodies.

This draft amendment enhances clarity around testing methodologies, ensuring common understanding and consistent application in health care technology and dentistry. The update addresses concepts essential for quality control, compliance, and performance evaluation in dental device and process standardization.

Key Topics

The amendment adds a dedicated section on standards development concepts, particularly focusing on the vocabulary for types of tests. The key terms defined include:

• Test: A systematic and defined procedure designed to assess characteristics, capabilities, or performance of a dental object, device, or process.
• Type Test: Evaluation of a single sample, assuming it represents the entire batch or product type. This test is essential when statistical analysis is impractical.
• Performance Test: Measurement of capabilities under specific conditions, with results reported in SI or derived units.
• Sampling Test: Testing a subset of items from a larger group to gain valid statistical insight into the overall quality.
• Routine Test: Regularly conducted tests to ensure ongoing proper functioning or performance.
• Compliance Test: Verification that products or processes conform to the standards’ specifications.

These comprehensive definitions support standard developers in designing appropriate testing protocols, enabling more reliable, repeatable, and internationally comparable evaluation processes.

Applications

The amendment's terminology revision offers practical value in several key areas:

• Standards Development: Provides clear test definitions helping committees and technical groups establish consistent and transparent testing procedures for dental products.
• Quality Assurance: Dental device manufacturers can use these definitions to develop and document their testing strategies, assuring product safety and effectiveness.
• Regulatory Compliance: Compliance tests detailed here facilitate regulatory agencies' verification processes, supporting product approvals and market access.
• Clinical Dentistry: Enhances communication among dental professionals regarding the reliability and performance criteria for dental instruments, materials, and equipment.
• Research and Development: Supports R&D by defining testing methods that can validate innovations, performance improvements, or new materials in dentistry.

By standardizing test-related vocabulary, this amendment helps align industrial, commercial, and healthcare interests, fostering innovation while maintaining patient safety.

Related Standards

EN ISO 1942:2020/prA1 complements the base ISO 1942:2020 standard on dental vocabulary and interacts with other healthcare and testing standards such as:

• ISO 9001 – Quality Management Systems, emphasizing testing and compliance processes.
• ISO 13485 – Medical Devices Quality Management, relevant for dental device manufacturing.
• ISO 7405 – Evaluation of biocompatibility of medical devices used in dentistry.
• ISO/IEC 17025 – Testing and calibration laboratories, which underpins competence in test execution.
• Relevant CEN and ISO standards related to healthcare technology vocabularies and procedures.

Together, these standards provide a broad framework for ensuring safety, consistency, and reliability across dental product design, testing, and regulation.

Keywords: Dentistry vocabulary, dental standards, test types definitions, performance test, type test, routine test, compliance test, sampling test, dental device testing, ISO 1942 amendment, standards development dentistry, healthcare technology standards, dental quality assurance.