Medicine as one of the main subjects of international regulation in the modern world

Updated: Feb 24


Medicine has always taken a leading position when it comes to creating regulatory documents. Since in the last year a lot of events have happened in this industry, therefore, a large number of detailed documents have been created to regulate the equipment used in it. Asking the question of COVID-2019, it should be noted that more preference and the need to combat this ailment was given to ventilation and oxygen equipment. That is why, in 2020, an even larger number of international standards have emerged that regulate this subcategory, with which we will introduce you today.


Medical electrical equipment — Part 2–69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601–2–69:2020)

ISO 80601–2–69:2020


Since the field of medicine is a complex concept, when discussing the technologies and equipment used, it is necessary to approach in a very detailed way when choosing international standards. Some documents cannot be applied separately, namely for individual pieces of equipment, and because of this, a whole system of documents is created that regulates both test methods and all subsequent stages of implementation of use and elimination of negative aspects. If your organization comes into contact with medical equipment that concentrates oxygen, we recommend that you familiarize yourself with the document that tells about the basic safety requirements approved at the international level.


Medical electrical equipment — Part 2–70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601–2–70:2020)

ISO 80601–2–70:2020


Like any other document, an international standard related to the field of medicine has its additions and individual parts, one of the additions, or rather a more global explanation of the previous standard, is EN ISO 80601–2–70: 2020.


This particular standard is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.


This particular standard excludes sleep apnoea breathing therapy equipment intended for use with neonates.


This particular standard is applicable to me equipment or an ME system intended for those patients who are not dependent on mechanical ventilation such as patients with central sleep apnoea.


This particular standard is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.


If a large number of technical terms and amendments do not give you a clear understanding of whether this standard can be applied in the industry where you operate, we recommend that you clarify all your questions with a team of specialists in the field of selection of international standards.


Medical electrical equipment — Part 2–67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601–2–67:2020)

ISO 80601–2–67:2020


Sometimes certain subcategories of the same industry may require different levels of standardization, which is why the application of certain parts of the standard can be redundant and not only useless, but also negatively influencing. For this, such standards are created which include certain parts such as EN ISO 80601–2–67: 2020.


This particular standard is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as me equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient’s inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.


This particular standard is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.


This particular standard is only applicable to active devices (e.g. Pneumatically or electrically powered) and is not applicable to non-active devices (e.g. Reservoir cannulas).


Since there are a very large number of similar aspects among the standards mentioned, we recommend that you clarify all the parameters in more detail to select the most suitable document to increase the productivity of your activity.


Dentistry — Vo cabulary and designation system for forensic oro-dental data (ISO 20888:2020)

ISO 20888:2020


Despite the popularity of the use of ventilation equipment, such a branch of medicine as dentistry has not gone unnoticed. In 2020, the creation of international standardization for this category continued, one of which is EN ISO 20888: 2020.


The purpose of this standard is to develop uniform nomenclature for the description of forensic dental data and define a standardized set of uniform terms to convey this information. The goal of the standard is not to define the extent of information collected, only to be certain that common terms are used in order to aid in an

identifying human remains or a living amnesiac.


Since this document is quite global and generalized, we recommend having it available to everyone whose field of activity is in contact with dentistry.


Ophthalmic instr uments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004–1:2020)

ISO 15004–1:2020


Since medicine and the equipment used in it are popularized more and more every day, the number of standards created for different industries is increasing. One such document is EN ISO 15004–1: 2020.


This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.


This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.


The introduction of innovations in the field of medicine is a very delicate aspect of compliance with rules and regulations, which is why we recommend adhering to the international system when applying innovative technologies in your field of activity.


Information techno logy — Security techniques — Requirements for bodies providing audit and certification of information security management systems (ISO/IEC 27006:2015, including Amd 1:2020)

ISO/IEC 27006:2020


The security of the data system, as well as management systems, is applied not only in the areas associated with these technologies, but also in medicine. Since every day more and more IT technologies are used in the field of treating people, therefore, the quality of data transmission will affect the safety of health. If you care about the quality of your medical services and data security, we recommend that you familiarize yourself with the EN ISO / IEC 27006: 2020 standard in more detail by clicking on the link attached above.


Medicine and its rapid advance to a leading position


Due to the fact that the demand for medical equipment has increased significantly, therefore, the amount of supply in the world market has increased. That is why the competition is gaining more and more momentum every day. One of the key aspects of competitiveness and the prospects for taking a leading position in the market is the quality of products and services, which can be achieved primarily by following the international standards created to regulate the entire system and industry. If your organization comes into contact with medical equipment indirectly or straightforwardly, in any of these cases, we recommend having several standards available that fit both globally for the scope of your activity and categorize the technologies you use. Stay tuned to iTeh for the latest international standardization updates





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