International standards for medical devices


The pace of innovative development is sometimes quite impressive and requires constant staff development in order to quickly adapt to the introduction of new technologies. Today, one of the main issues on a global scale is the issue of the health of each person, which is why all investments and mainly basic scientific and technical research are aimed at creating medical equipment that greatly simplifies the solution of emerging problems in medicine as a whole. In order for each company that comes into contact with the field of medicine to have high-quality equipment, and also to bear full responsibility for the activities carried out, such regulatory legal acts as international standards are being created, with the main ones for medical equipment we will introduce you today.

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

EN ISO 17511:2021

The influence of international standards on the construction of the medical system cannot be underestimated, because the regulation of both global industries and its individual subcategories is significantly responsible for human life as a whole. When it comes to international standards governing certain parts of medical equipment, you should always be aware of their updates, since technologies do not stand still and require constant adaptation to new market requirements. One of the most recent significant standards in the medical device industry is EN ISO 17511: 2021.

This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs). All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.

NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.

This document is applicable to:

a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.

b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.

c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).

d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.

e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).

This document is not applicable to:

a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;

b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;

c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;

d) properties reported as nominal scales and ordinal scales, where no magnitude is involved. NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles

The detailed technical characteristics described in the annotation to this standard will allow you to form a clear picture of the possibilities for its implementation in your organization. It should be understood that the application of this or that international document requires a correct understanding of the terminology in order to minimize possible risks. This is why additional clarifying documents may be required to create a strong regulatory framework.

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6: 2021)

EN ISO 13408-6: 2021

Isolation systems are a complex concept in medicine and due to the latest developments in the world, the equipment used in the field of medicine is constantly being improved. The introduction of innovations is accelerating at its own pace and, as a result, requires the acceleration of adaptation processes. If your field of activity involves the use of the aforementioned systems EN ISO 13408-6: 2021 will become a kind of navigation system in the innovative development of your activity, as well as increasing the scale of your activities.

Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253: 2021)

EN ISO 15253: 2021

Optical devices are ubiquitous in the life of every person. When this equipment comes into contact with the medical sector, its implementation and operation will always require a resolution of safety issues. Today, the previous methods of interacting with equipment are becoming obsolete and every day more and more norms and requirements are being created, both locally and globally. International standardization is a leader in the regulatory documents market and is a navigation system for expanding business and helping to enter new markets. You must always have the latest standards in order to stay dominant in your industry. One of the highest quality recommendation and regulatory documents for optical equipment today is EN ISO 15253: 2021.

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1: 2018 / Amd 1: 2021)

EN ISO 11737-1: 2018 / A1: 2021

Laboratory research is the first stage in the formation of a global base for the further creation and construction of innovative innovations. International standardization, which focuses on these processes, is actively developing both within individual countries and at the global level. Companies that follow the norms and requirements of these documents are developing at a much faster pace than competitors, leveling their importance. It should be understood that the presence of one standard is not sufficient for building a whole productively functioning structure, which is why whitewash supplementary documents are created, which are auxiliary, one of which is EN ISO 11737-1: 2018 / A1: 2021.

Simple solutions to complex problems

Laboratory follow-up can be carried out both locally and in private organizations, and at the global level. In order to deal with global problems, in any case, it should be understood that whatever activity is carried out by organizations, corporations, small and medium-sized businesses, most of it is focused on obtaining financial profit, and that is why the issue of minimizing risks becomes one of the key ones. In this case, the implementation of international standards will help you not only to facilitate the construction of the entire process, but also to significantly increase the productivity of your activities. If you do not know which standard is required for your equipment, we recommend that you periodically consult with specialists who operate in the field of selection of international standards.