International Medical Device Standards


The pace of innovation is sometimes impressive and requires constant staff development to adapt quickly to the introduction of new technologies. every person, all investments, and especially basic scientific and technical research, are aimed at creating medical teams that greatly simplify solving problems that arise throughout medicine. In order to have high quality equipment and also to take full responsibility for the activities carried out, regulatory acts such as international standards are created, the most important for medical devices that we are presenting to you today.


In-vitro diagnostics Requirements for establishing the metrological traceability of the values ​​assigned to calibrators, authenticity control materials and human samples (ISO 17511: 2020)

EN ISO 17511: 2021

The influence of international standards on the design of the medical system should not be underestimated because the regulation of both global industries and their individual sub-categories is largely responsible for human life as a whole. When it comes to international standards for certain parts of medical devices, you should always be aware of their updates, because technologies do not stand still and require constant adaptation to new market requirements. One of the most recent important standards in the medical device industry is EN ISO 17511: 2021.

This document specifies the technical requirements and documentation necessary to ensure the metrological traceability of the values ​​assigned to the calibrators, the control materials and the authenticity and human values ensure ampoules for amounts measured by IVD doctors.Human samples are measured for those intended as specified for each MD IVD. The deminentological traceability of values ​​for amounts in human samples extends to the component of the highest available reference system, ideal for RMPS and certified reference materials (ZRM).


All parts that have described a paper described in one of the steps in a calibration hierarchy for an MD IVD requirements. These parts include, but are not limited to the manufacturer (from IVD MDS), RMP developer (see ISO 15193), RM manufacturer (see ISO 15194) and Reference Laboratories / Calibration (see ISO 15195), which supports calibration hierarchies for IVD MDS .


Note 1 RMS Manufacturer for use in IVD MDS Standardization or calibration are commercial and non-commercial organizations, the products RMS for the use of many IVD MDS Earthmen and / or calibration laboratories or to use a single end user medical laboratory, as in the For a measurement standard (calibrator), which are developed exclusively for the calibration of a laboratory pH.


This document is applicable to:


a) All IVD MDS supplying measurement results in the form of numerical values, that is, rational scales (proportions) and / or differential (interval), and scales count.


b) MDS IVD, where the result of the measurement is fixedly reported as a qualitative value with a proportion of two measurements (that is, the signal from a sample, which becomes a particular concentration or activity in the tested and the signal a RM ) or a counting scale, with a corresponding decision threshold (S). This includes the IVD MDS, where the results are divided between ordinal categories, based on predetermined quantitative intervals for an amount.


C) For use as a triess control materials for the review or evaluation of the calibration of the IVD MDS determines RMS, that is, switches on a few CRMS and some external quality evaluation materials (EQA) (EQA) (if specified in the RM intended use.


d) MDSPECIFIC IVD calibrators and control materials Triess with associated values, determined together with a particular IVD MD.


e) IVD MDS according to a) and b), where it is not necessary enduser executed (ie, if the manufacturer makes a factory calibration of the IVD MD).


This document is not applicable to:


a) calibrators and control materials for drinking MDS IVD, which is known to have a zero amount of measurement due to their formulation, and;


b) Control materials used only for internal quality control in medical laboratories in order to evaluate the inaccuracy of an IVD MD to evaluate either repeatability or reproducibility and / or changes in the results of the IVD MD compared to a predetermined Calibration condition;


c) control materials that are used only for internal quality control in medical laboratories and serving with proposed acceptable value areas that do not detect the components of the higher-order reference system measurement; Reforted


d) Properties such as the rated scales and ordinal scales in which it is not for magnitude.


Note 2 The nominal scales are normally used to inform eg. identity


The detailed technical characteristics described in the note to this standard enable you to get a clear picture of the possibilities of implementation in your organization. It is understood that the application of this or that international document requires a correct understanding of the terminology in order to minimize possible risks. Therefore, additional clarification documents may be needed to create a robust regulatory framework.

Aseptic Processing of Health Products Part 6: Isolation Systems (ISO 134086: 2021)

EN ISO 13408-6: 2021


Isolation systems are a complex concept in medicine and due to the latest developments in the world, the devices used in the medical field are constantly improving. The introduction of innovations is accelerating at its own pace and therefore requires the acceleration of adaptation processes. If your field of activity includes the use of the above systems, in addition to increasing the scope of your activities, EN ISO 13408-6: 2021 will become a kind of navigation system in the innovative development of your activity.

Optics and ophthalmic instruments Optical and electro-optical devices to improve poor eyesight (ISO 15253: 2021)

EN ISO 15253: 2021

Optical devices are ubiquitous in everyone's life.When these devices come into contact with the medical field, their implementation and operation will always require a solution to security problems, nowadays the previous methods of interaction with the devices become obsolete and every day more and more standards and requirements, both locally and globally . International standardization is the market leader for regulatory documents and is a navigation system for expanding business and entering new markets. You should always have the latest standards to stay dominant in your industry. One of the highest quality The recommendation and regulatory documents for optical devices today are EN ISO 15253: 2021.

Sterilization of health products Microbiological processes Part 1: Determination of a population of microorganisms in products Amendment 1 (ISO 117371: 2018 / Amd 1: 2021)

EN ISO 117371: 2018 / A1: 2021

Laboratory research is the first stage in the formation of a global basis for larger creation and construction of groundbreaking innovations.International standardization, which focuses on these processes, is actively developing both in individual countries and around the world: companies that follow the standards and requirements of these documents develop much faster than the competition and level their importance. that the existence of a standard is not sufficient to build a structure that functions productively as a whole, which is why supplementary cover-up documents are created that are auxiliary, including EN ISO 117371: 2018 / A1: 2021.

Simple solutions to complex problems

Laboratory monitoring can be carried out both locally and in private organizations and on a global scale.To deal with global problems in any case, it should be understood that every activity of organizations, companies, small and medium-sized enterprises, most of them are aimed at economic gain, therefore, risk minimization is seen as one of the keys. In this case, the implementation of international standards will not only help you to facilitate the structure 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 regularly consult with specialists who are active in the field of selection of international standards.


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