What is ISO/TR 30171:2016 ?

Title: Understanding ISO/TR 30171:2016 and EN ISO 11608-1:2016

Measurement is a critical aspect of many industries, and the accuracy of results depends on the reliability and consistency of the measurements. ISO 16610-2:2016 and EN ISO 11608-1:2016 are two important technical standards that help ensure accurate measurements and reliable data analysis. In this article, we will provide an overview of ISO 16610-2:2016 and EN ISO 11608-1:2016 and their significance in the field of metrology.

ISO 16610-2:2016: The Principles

ISO 16610-2:2016 is a standard that specifies multiple attributes of surface texture parameters. It provides guidelines for evaluating the characteristics of surfaces, such as roughness, waviness, and lay. The purpose of ISO 16610-2:2016 is to define standardized measurement procedures and terminology for assessing various surfaces, ensuring consistency and comparability in the evaluation process.

ISO 16610-2:2016 is based on the principles of object measurement, which involves the measurement of the properties of a surface using a standardized tool or method. The standard defines a set of requirements for the evaluation of surfaces, including the use of standardized nomenclature, the establishment of measurement procedures, and the definition of terms used in the evaluation of surfaces.

ISO 16610-2:2016 also provides guidelines for the selection of appropriate measurement instruments, the preparation of measurement data, and the interpretation of measurement results. By establishing a common language for surface texture parameters, ISO 16610-2:2016 ensures that manufacturers, users, and assessors can agree on the characteristics of surfaces and the accuracy of the results.

EN ISO 11608-1:2016: The Purpose

EN ISO 11608-1:2016 is a technical standard that provides guidelines for the design and testing of autoinjectors for medical use. Autoinjectors are medical devices used to deliver a specific dose of medication to patients. This standard, recognized worldwide, ensures the safety, reliability, and quality of autoinjectors.

EN ISO 11608-1:2016 is designed to establish a set of requirements for autoinjectors that ensure consistent performance, user-friendliness, and safety. The standard covers various aspects, such as the compatibility with different medications, accurate dosage delivery, ease of use, reliability, and safety.

The primary aim of EN ISO 11608-1:2016 is to establish a common language for the design, testing, and evaluation of autoinjectors, which can help manufacturers produce devices that meet essential criteria for safety, reliability, and quality.

Key Requirements of EN ISO 11608-1:2016:

EN ISO 11608-1:2016 provides several key requirements that manufacturers must meet to ensure compliance with the standard. These requirements include:

Medical device regulations: The device must be designed, manufactured, and tested in accordance with relevant medical device regulations, such as the Medical Device Regulation (MDR) 2017/745 and the US Food and Drug Administration (FDA).

Design and construction: The device must be designed and constructed to ensure safety, reliability, and quality. This includes the use of appropriate materials, the choice of components, and the implementation of appropriate design features.

Performance: The device must demonstrate adequate performance, including accurate dosage delivery, reliable performance, and safety features.

Test procedures: The device must undergo various tests, including clinical trials, to ensure that it meets the requirements of the standard.

Documentation: The device manufacturer must maintain records of the device design, testing, and performance, including results of any tests and any deviations from the requirements.

Conclusion:

ISO 16610-2:2016 and EN ISO 11608-1:2016 are two important technical standards that help ensure accurate measurements and reliable data analysis. By establishing standardized measurement procedures and terminology for surfaces and medical devices, these standards provide consistency and comparability in the evaluation of various surfaces and devices. Adhering to these standards can help manufacturers develop products that meet essential criteria for safety, reliability, and quality.