Medical equipment as an object for ISO regulation

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In the modern world, medical equipment is more and more exposed to the introduction of innovations and the automation of all processes. Despite the fact that a huge number of technologies and new uses for old equipment are increasing every day, human labor in the field of medicine cannot be completely replaced today. When it comes to human health, there is a need to create a huge number of regulatory documents that regulate the implementation of innovations and the operation of existing equipment, as well as the general principles for the application of international standards. One of the most popular documents of this type today are ISO standards, with the last of which we will introduce you today.

Ventilators and related equipment - Vocabulary and semantics (ISO 19223: 2019)

EN ISO 19223: 2021

In order to apply international standards in the correct way, it is necessary to clearly understand the terminology that it describes. Indeed, for each type of equipment, there are different medical terms that can significantly affect the activities carried out. In this case, supplements to international standards come to the rescue, or rather their individual parts, which clarify the vocabulary used. One example of such documents is EN ISO 19223: 2021.

This document establishes a glossary of terms and semantics for all areas of respiratory care, including mechanical ventilation, such as intensive care ventilation, anesthetic ventilation, emergency and transport ventilation, and home ventilation, including sleep apnea respiratory therapy equipment. This is applicable

  • in the standards for ventilators and respiratory therapy,

  • in health informatics standards,

  • for marking medical electrical equipment and medical electrical systems,

  • in the operating instructions for medical electrical equipment and medical electrical systems and accompanying documents,

  • for the interaction of medical electrical equipment and medical electrical systems

  • in electronic medical records.

This document also applies to accessories designed by the manufacturer for connection to a ventilator breathing system or ventilator where the characteristics of those accessories could affect the basic safety or essential performance of the ventilator and ventilator's breathing system.

NOTE This document may also be used for other ventilation applications including non-electrical devices and equipment, research, critical event reporting, forensic analysis, and adverse event reporting systems (vigilance ).

This document does not specify terms related to respiratory therapy equipment or physiological closed-loop ventilation, high-frequency ventilation, or negative pressure ventilation; nor for respiratory support using liquid ventilation or extracorporeal gas exchange or oxygen, except when it was considered necessary to establish boundaries between border concepts.

If your field of activity comes into contact with the equipment that is mentioned in the annotation to this standard, we recommend having it available so that the implementation of international standardization in your organization has only positive consequences.

Molecular diagnostic tests in vitro. Specifications of processes for preliminary examination of human samples. Isolated microbiome DNA.

CEN / TS 17626: 2021

Laboratory research is a relatively new type of human activity if we talk about it on a global scale. An increasing number of private organizations are engaged in the invention of new drugs and technologies related to human health, which is why there is a need for international standardization specifically for this industry. One notable example of such international standards is CEN / TS 17626: 2021.

This document defines the requirements and gives recommendations for the preliminary examination of human samples, such as stool, saliva, skin and urogenital samples, intended for microbiome DNA testing. The preliminary research phase includes, but is not limited to, sample collection, handling, transport, storage, handling, DNA extraction and documentation. This document is applicable to in vitro molecular diagnostic tests performed by medical laboratories. It is also intended for use by laboratory clients, developers and manufacturers of in vitro diagnostics, biobanks, biomedical research institutions and commercial organizations, and regulatory bodies.

Various special measures are taken for screening processes for the study of infectious diseases (for example, targeted identification of pathogens) and for the study of microbiome DNA from tissues (for example, biopsy). This is outside the scope of this document.

Various special measures are taken for the processes of preliminary examination of saliva for the study of human genomic DNA. They are not described in this document, but are addressed in CEN / TS 17305, In Vitro Molecular Diagnostic Research - Specifications for Saliva Pre-Examination Processes - Isolated DNA.

NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this document.

The measures prescribed in this document make it possible to minimize the possible risks associated with financial losses in the course of research related to DNA. It should also be noted that this document has a certain number of amendments, or rather clarifications, what exactly it does not include. We recommend that you pay attention to these aspects in order to be sure that the document you have purchased will be able to qualitatively improve the activities carried out.

Dentistry - Intraoral camera (ISO 23450: 2021)

EN ISO 23450: 2021

Medical standards created by the ISO Institute can be created both for global categories and for individual branches of human activity. In this case, we are talking about the division of standards in medicine. International standards are created both for medical equipment and to regulate their use in certain categories, such as, for example, surgery, dentistry, cardiology, and the like. One of the most recent standards governing the use of equipment in dentistry is EN ISO 23450: 2021.

This document specifies the requirements and test methods for intraoral cameras used in patient dentistry to graphically depict the oral cavity to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and labeling. This document does not apply to

a) active polymerization activators for the polymerization of dental materials;

b) an exclusively extraoral camera for preparing reviews or recording treatment;

c) dental microscopes for minimally invasive treatment;

d) medical endoscopes;

e) attachments for cameras for illuminating teeth (transillumination);

f) attachments for CAD / CAM scanners;

g) combinations of dental instruments with camera functions;

h) endodontic chambers;

i) devices for examination of root canals (endoscopic microcameras);

j) cameras for navigating instruments;

k) cameras for determining the color of teeth.

A detailed listing of characteristics and parameters to which this document does not apply, makes it possible to understand in which categories of dentistry this international standard will not be appropriate. That is why you should pay great attention to the annotations for each standard and also rely on the technological base present in your organization.

Medical electrical equipment - Part 2-87: Specific requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87: 2021)

EN ISO 80601-2-87: 2021

We have already mentioned that in connection with the active development of innovation technologies, all processes are globally automated. This process does not bypass the medical sector and an increasing number of new equipment is being introduced, and as a result, it requires the creation of regulatory documents for their implementation and application, one of which is EN ISO 80601-2-87: 2021.

ISO 80601-2-87 applies to basic safety and essential performance of high frequency ventilator (HFV) in combination with its accessories, hereinafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and require comprehensive care and constant supervision in a professional medical institution; - designed to be operated by a professional medical operator; - Designed for patients requiring varying levels of support from mechanical ventilation, including ventilator-dependent patients; and - capable of providing over 150 inflations / min. There are three main designations for HFV: - high frequency impact ventilation [HFPV, with a typical HFV rate (60 to 1,000) HFV / min inflation]; - high-frequency jet ventilation [HFJV, with a typical HFV frequency equal to (from 100 to 1,500) inflation HFV / min]; and - high frequency oscillatory ventilation [HFOV, with a typical HFV rate (180 to 1200) HFV inflation / min and usually with active expiration].

The use of international standards of this kind increases the guarantees of minimizing risks and also greatly simplifies the process of familiarization with new equipment, which in turn improves the quality of the use of innovations and the indirect effect.

Safety and quality are the key points for the success of your organization

The safety of human life is the most important point to focus on when it comes to organizations related to medical technology. Incorrect implementation of standards can entail not only financial risks or risks of breakdown of certain equipment, but in the first place can harm human health. That is why the implementation and constant updating of international standards in medical organizations is not just a recommendation, but a requirement that you should adhere to and keep abreast of the latest documents in the part of medicine in which you operate. In order to avoid the error of acquiring an incorrect standard, you can always consult with a team of specialists and significantly strengthen the scientific and technological base of your organization.