The population has grown quickly and is still growing at a rapid rate in the twenty-first century. Due to the increased birth rate on the planet, some medical advancements have been made that have significantly improved the standard of healthcare and paved the way for the adoption of cutting-edge technologies. Nevertheless, due to certain traits of health indicators, reproductive activity may be dangerous for some people and may have some negative effects. Some forms of contraception were developed for this reason. Since this subject primarily relates to human health, it is strictly governed by international standards, the most important of which we will familiarize you with today.
Condoms for women — Application of ISO 25841 and condom quality control
ISO/TR 24484:2023
There are many standards and requirements that must be met in order to control the production and use of devices used in the healthcare or related industries. Due to the prevalence of female contraceptives today, production is strictly governed by international standards like ISO/TR 24484:2023.
This document provides the fundamental guidelines for applying ISO 25841. It describes in detail the components that must be used in the quality control of female condoms in accordance with related regulatory standards, as mentioned in ISO 25841 and other pertinent ideas. Aspects of quality management to be taken into account during the development, manufacture, quality assurance, and procurement of female condoms are covered in this document, which is a supplement to ISO 25841. It includes the fundamentals of quality management systems and places an emphasis on the functionality, security, and dependability of female condoms during their design, production, and delivery. This guideline is relevant to retention devices that are essential parts of female condoms made of natural rubber, synthetic rubber, or synthetic polymers.
NOTE ISO 25841 addresses female condoms made of synthetic polymers, natural rubber latex, or natural rubber latex.
When using this International Standard, keep in mind that it contains specific technical requirements; if your product doesn't meet those requirements, you must refer to the standards in the adjacent category of regulation.
Effect on condom strength of additional lubricants for male natural rubber latex condoms
ISO 19671:2018
Since the primary goal of all forms of contraception is protection, it is important to realize that using a method that contains one or more components that were produced with low quality can have unfavorable effects on human health. Because of this, the quality of contraceptives is now regulated by an international standard called ISO 19671:2018.
This document outlines a procedure for evaluating the impact or compatibility of a second lubricant with lubricated male natural rubber latex condoms. Additionally, it applies to anything else that comes into contact with these condoms, including topical medications. After being exposed to the test substance, the condoms' physical characteristics are measured (i. e. such as lubricant or topical medication. ) and outlines the pass/fail requirements for such modifications.
The assessment of the compatibility of lubricants applied to a condom at the time of manufacture is not relevant to this document. It does not directly relate to determining whether a specific condom is compatible with lubricants or other substances. While similar concepts may still be used in tests using female condoms, it is not directly applicable. The test procedures are applicable to condoms made of natural rubber latex and synthetic materials, but only natural rubber latex is required to have a pass/fail criterion.
We firmly advise that you pay attention to the international standards that set the rules for this industry if your business is involved in the production of this kind of product. Since this product affects human health, it is important to keep that in mind first.
Advice on the planning, carrying out, analyzing, and interpreting clinical trials for copper-bearing intrauterine contraceptive devices
ISO 11249:2018
A number of clinical studies are conducted before any health product is put into production in order to understand the level of safety of its use as well as the potential for and necessity of mass production. ISO 11249:2018 is one standard that clarifies clinical research for contraception.
Guidance on the design and execution of clinical studies to ascertain the performance characteristics of novel intrauterine devices is provided by ISO 11249:2018. Additionally, it offers suggestions for data analysis after the study is finished and for how manufacturers, researchers, and regulatory bodies should interpret the findings.
Assisting sponsors, monitors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices, ISO 11249:2018 aims to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results.
The compensation of subjects, the confidentiality of subjects' records, the use of local ethics committees, and other issues related to clinical trials are not covered in this document. ISO 14155 goes into great detail about these and many other clinical trial design issues.
We urge that both the businesses involved in the aforementioned product's production and the laboratories conducting clinical trials have access to this International Standard. You can click the link to our website to learn more about all the documents in this category and see a longer list of standards if you're interested.
Female condoms, clinical function studies based on self-reports, part two of the guidance on clinical studies for condoms
ISO 29943-2:2017
Because they lack their own laboratories, some industries are forced to rely solely on the scientific and technological foundation of previous studies. But one must realize that this technical and scientific foundation was created by scientists working in a different fields and that it calls for an understandable justification. International standards like ISO 29943-2:2017 are very helpful in these situations.
The purpose of ISO 29943-2:2017 is to support the design, execution, analysis, and interpretation of clinical function studies carried out in accordance with ISO 25841's specifications for female condoms. In these clinical studies, the effectiveness of a fresh female condom is contrasted with that of an older condom when used during vaginal (as opposed to anal) sex. These studies are specifically made to evaluate incidents of acute failure while in use. Additionally, ISO 29943-2:2017 offers guidance on how data analysis and result interpretation by manufacturers and regulatory bodies should be done after the study is finished.
The use of local ethics committees, payment of participants, and other aspects of clinical trials are not covered in this document. The ISO 14155 standard goes into greater detail about these and many other clinical trial design issues.
Any standard relating to human health has a number of technical and terminological aspects that can be challenging to explain to someone involved in a business process. You can consult with our expert, who will provide all the information you need, if you have any questions about which international standard you should buy.
The necessity of maintaining product quality through the application of global standards
Implementing and using international standards, especially in large-scale industries, is crucial because they are one of the ways to prevent mistakes from occurring during the production of a specific product. In order to improve financial performance and, as a result, enter global markets, scaling up is today's primary task for almost any production. Because of this, it is now impossible to imagine large corporations operating in any category without adhering to international standards. After all, it is these documents that in some ways standardize the production of a specific good and give market participants the ability to compete on competitive advantages, particularly in terms of quality and adherence to local or regional standards.