In the light of recent events on the world stage, the production and use of protective medical equipment have increased significantly. It should be noted that with the emergence of increased demand, the number of proposals and production in this area also increased. Since the main issue of quality is responsible for human lives, the standardization of this aspect has become much stricter, more and more norms and standards arise every day. Compliance with international rules in the field of production, sale and use of protective equipment can affect not only the level of demand for your products both in the domestic and foreign markets, but also on the company's image, which will determine the further vector of the company's development. Today, we will introduce you to the most basic international standards applicable to medical protective equipment.
Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
Protective gloves are used everywhere and for different purposes. Medical supplies require a narrower specification with appropriate standards. Moreover, when it comes to specifications in the field of protective equipment and methods for testing them, the necessary standards are created for each specification in the field. As far as there is a big variety of medical equipment specifications in determining the exact standard is one of the key points of successful performance. One of such documents is EN ISO 374-5:2017. This European Standard specifies a test method for the penetration resistance of gloves that protect against micro-organisms. As far as this standard has a narrow specialization, follow the link to the website to get more detailed information about the document and the possibilities of using it in a correct way.
Protective gloves - General requirements and test methods
The use of protective gloves was previously associated only with specific professional actions. But times are changing, and today protective gloves are used even in everyday life by people. Production of medical devices is increasing from day to day and its quality significantly influences not only the image of the company but also the long term perspective of development. To standardize their production, ISO 21420 was created. This document specifies the general requirements and relevant test procedures for glove design and construction, innocuousness, comfort, and efficiency, as well as the marking and information supplied by the manufacturer, applies to all protective gloves. It can also apply to arm protectors and gloves permanently incorporated in containment enclosures. Gloves and hand protectors such as mittens, pot holders, and arm protection are covered by this document. We strongly recommend focusing on the quality of the production and its accordance with international rules. In this way of development, you will be sure that all possible risks occurring in the international market will be prevented.
Medical gloves made from natural rubber latex -- Determination of water-extractable protein using the modified Lowry method
Protective gloves are used everywhere and for different purposes. Medical supplies require a narrower specification with appropriate standards. One such document is ISO 12243: 2003 This standard specifies a method for the determination of the amount of water-extractable protein in natural rubber (NR) gloves for medical use. The method is potentially suitable for the determination of extractable protein in other articles made from NR latex; however, the extraction procedures and times have not been validated and will vary with the type of article to be tested. Other methods for the determination of specific proteins in medical gloves exist (these are described in an annex) but they are not of general applicability. This International Standard is concerned solely with the method of assay. It is not concerned with sampling nor does it purport to address the safety implications of the values obtained or requirements for labeling. If you have any questions about this standard and whether it is applicable to the area of the performance of your company, please contact Iteh for clarifying the details.
Cosmetics -- Microbiology -- Testing of impregnated or coated wipes and masks
Previously, masks were used only in certain areas of activity. Today, they are used even when people go to the store. That is why many new standards have arisen. It should be mentioned that using the norms that regulate protective devices stands for the safety of people. One of the legal acts governing impregnated or coated wipes and masks is ISO 21322: 2020. This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing. In case you need to understand a more detailed description of possible variants of application the standard follows the link to the ITeh website.
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. Due to the last events in the world paying attention to the standards of medical devices production has significantly increased. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Compliance of medical devices is checked in accordance with a number of regulatory acts, of which one of the standards is ISO 17510. This document applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy. If you have any questions about the details and specifics of this document that is needed for improvement your business, contact Iteh to clarify all the details you are interested in.
Protective gloves and other hand protective equipments against thermal risks (heat and/or fire)
We have already introduced you to the international standards governing the production of protective gloves. We want to inform you about the existence of a more specialized document - EN 407:2020. This European Standard specifies requirements, test methods, marking and information for protective gloves against heat and/or flame and hands protective equipment against domestic thermal risks. It should be used for all gloves and hands protective equipment which protect the hands or part of the hand against heat and/or flame in one or more of the following forms: flame, contact heat, convective heat, radiant heat, small splashes or large quantities of molten metal. The knowledge of international standards not only increases competitiveness in your field of activity, but also prevents dangerous risks, especially when it comes to people's lives. Stay safe with Iteh.
Clothing for protection against infectious agents -- Medical face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
Protection against infections is one of the most pressing issues today. International standards governing their production are necessary for the regulation of their production. More than that every time of business nowadays need a certain level of awareness of the medical protection standards to minimize possible risks and increase the productiveness and safety level. One of such documents is ISO 22609: 2004. This standard describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood. The test method does not address the performance of the medical face mask's design, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). For getting more detailed information that may significantly change the way of organizational processes, follow the direct link to this standard.
Respiratory protective devices -- Vocabulary and graphical symbols
Respiratory Protective devices is a particular type of Personal Protective Equipment, used to protect the individual wearer against the inhalation of hazardous substances in the workplace air. It should only be used where adequate control of exposure cannot be achieved by other means. Like any other field of activity, respiratory devices need regulation from a normative point of view. One of the documents standardizing Respiratory Protective devices is ISO 16972. This document defines terms and specifies units of measurement for respiratory protective devices (RPDs), excluding diving apparatus. It indicates graphical symbols that can be required on RPDs, parts of RPD or instruction manuals in order to instruct the person using the RPD as to its operation. Compliance with international norms and standards not only accompanies quality, but also reveals the possibilities of interaction on the international market. In case your business is connected with respiratory devices connect with Itech and expand the boundaries of your business.
Correct standard use can change the speed and scale of the company’s growth.
As mentioned above, the need for awareness of medical device standards is an integral part of the development of any business. The world is changing and putting forward new rules of the game in the market. Thus, in order to become a winner in the world of competition, which is increasing every day, you need to be sure that the internal structure is in accordance with international norms and standards. It should also be noted that the field of medicine is a rather complex concept and the issue of verifying the most suitable standard for your company should be seriously considered. If you want to know about the need for certain regulatory legal acts for your business, go to the iTeh website for more detailed information.
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