Human health care has always been one of the most relevant areas and industries that then began to emerge as a business category. Development and financial results, which, as we can see, have influenced global processes, especially in the last two years. As the health sector is one of the most unified, interaction with technology is not just a recommendation for accelerated development. Therefore, there is a need to build a scientific and technological base that greatly simplifies the process of interaction between organizations and companies in different countries between individual subjects in this branch. internationally it is the international standard. Today we will familiarize with some of the most important documents in the field of equipment and medical technologies.
Absorbent Products for Urinary and / or Fecal Incontinence Names and Images of the Product Type (ISO 22748: 2021)
EN ISO 22748: 2021
For each type of medical activity, as well as a specific methodology for conducting research and the conclusion that the results will create their own international standards created. When we talk about absorbents and their use in medical practice, we have to mention an international document that is as important as EN ISO 22748: 2021.
This document gives names and examples of recommended and other types of products. Illustrations of the product categories according to ISO 9999, subclass 09 30, "Absorbent products for the absorption of urine and faeces".
A feature of this International Standard is not only that it describes the characteristics of the methods and gives technical recommendations, but also certain standards for the use of accompanying visuals.
Sterilization of medical devices Biological indicators Part 8: Procedure for validating a shortened incubation time for a biological indicator (ISO 111388: 2021)
EN ISO 11138-8: 2021
With regard to the occurrence of the coronavirus, the disinfection problems and sterilization have also been in the daily life of the Mankind gained importance. When it comes to this category in a professional sense, great attention is paid to the normative legal documents regulating this sub-category of medicine. One of the most recent significant international standards in this context is EN ISO 11138-8: 2021.
1.1 This document specifies the requirements for a test method that is used to establish or confirm a reduced incubation time (RIT) that is shorter than the reference incubation time is of 7 days according to 7.3.22 of ISO 111381: 2017 for biological indicators used to monitor wet heat sterilization processes or ethylene oxide (EO) sterilization processes.
1.2 This document applies to manufacturers of biological indicators and end users of biological indicators who intend to establish, validate or confirm an RIT, if this is required by their quality system.
1.3 This document does not apply to biological indicators for monitoring sterilization processes with dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2).
NOTE 1 The procedure described in this document for establishing an RIT for biological indicators to monitor moist heat or EO sterilization processes has been in widespread use for many years; However, there is only limited experience with this method for establishing an RIT for biological processes. Indicators for monitoring dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes, therefore this document does not cover these sterilization processes.
NOTE 2 For EO as a sterilant, the stated RIT applies to each type of EO cycle; H. 100% EO, EO mixtures, etc. It is important to understand that each international standard specializes in a separate product.In order for the application of the international standard to produce the most productive results, we recommend that you study in detail the comments and technical characteristics of this or that document.
Washer-disinfectors Part 5: Performance requirements and test method criteria for the verification of the cleaning effect (ISO 158835: 2021)
EN ISO 15883-5: 2021
Disinfectants can be used both in the professional sense, i. H. in medical institutions, as well as in the daily life of every person. Since the quality of this equipment and related materials is directly responsible for human health and safety, great attention is paid to establishing international standards for this category. One of the most current international standards for the washing of disinfectants today is EN ISO 15883-5: 2021.
This document specifies the procedures and test methods that are used to determine the cleaning efficiency of Washer-Disinfectors (WD) and their accessories for the Cleaning of reusable devices to prove medical devices.
NOTE 1 The requirements can be applied to washer-disinfectors intended for use with other items used in medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to activities that must be performed by manufacturers of reusable medical devices.
Like any other international standard, this document has a number of changes, so you should be aware of them so that implementation of this international standard is of the highest quality and most productive for your business.
Medical electrical equipment Part 274: Particular requirements for the basic safety and essential performance characteristics of respiratory air humidification equipment (ISO 80601274: 2021)
EN ISO 80601-2-74: 2021
The medical field of human activity is regulated by international standards, not only with regard to the materials used, but also the categories in which a large number of innovative electrical devices are used. One of the most widespread and most important international standards for medical electrical devices today is the basic safety and essential performance of a humidifier, hereinafter also referred to as ME device, in combination with its accessories, the combination hereinafter also referred to as ME system. Humidifiers where the properties of these accessories may affect basic safety or essential performance Hazards associated with the intended physiological function of ME devices or ME systems within the scope of this document are not covered by the specific requirements of this document, except in IEC 606011: 2005 + AMD1: 2012 + AMD2: 2020, 7.2. 13 and 8.4.1.
This International Standard, despite the existence of common features, has a number of modifications and clarifications that give this document a narrow profile. We strongly recommend that you pay attention to the specifications of the devices, which are governed by each international standard.After all, the problems of medicine and its legal regulation have a direct impact on the safety of human life.
Tools Guidelines for cognitive accessibility Daily time management (ISO 21802: 2019)
EN ISO 21802: 2021
Although international standardization mainly focuses on the regulation of global systems and large and large equipment scales, separate documents are also included that regulate accessories and auxiliary technologies or can give general recommendations for the application of more sensible standards. A notable example is EN ISO 21802: 2021.
This document defines principles of cognitive accessibility in the area of daily time management. This document provides guidelines for the application of the design of features and functions that are known to improve the accessibility of products and systems that are used to aid in day-to-day time management for people with cognitive impairments
regardless of age. This document does not contain specific test methods and instructions for measuring and reporting.
This International Standard is more complementary than a stand-alone document if you are interested in building a proven system in which the activities carried out are carried out not only in the most productive way with the lowest cost, but also in the most efficient way I strongly recommend to produce a number of additional documents that can minimize potential risks and expand your company's potential opportunities.
Dependence between security, industry development and international standards ISO
At first glance, the relationship between the implementation of a particular document and the security of financial results is difficult to understand, but it should be understood that the concentration of production in one part of the world or the other increases the requirements for the first places in the market are significant, so that competitiveness should be at a reasonable level. This can only be achieved by complying with the norms and requirements prescribed in international standards. If you need advice on obtaining useful documents for your company, we will be happy to help you open up new opportunities in your industry.