Medical equipment is quite diverse in terms of the methods of its use, as well as the complexity of using and implementing updates. Recently, an increasing amount of artificial intelligence is being introduced into any type of equipment, thereby facilitating the possibility of its use, but on the other hand, complicating and lengthening the adaptation process. In order for the introduction of innovations to become the safest, to minimize possible physical financial risks and also to create a unified system at the international level, regulatory documents are being created that regulate the aforementioned processes. Today we want to introduce you to the international ISO standards for cardiac equipment. If your field of activity comes into contact with this type of equipment, we strongly recommend staying up to date with the latest developments in the field of international standardization to be sure of the complete safety of existing processes in your production or organization.
EN ISO 5840-1:2021
Prostheses have been used for quite a long time and in the field of cardiac surgery are an element that saves human lives, which is why it is necessary to comprehensively approach their application of methods and qualities. The international standard regulating this issue is EN ISO 5840-1: 2021.
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components.
The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.
When it comes to human health, it is necessary to approach each stage of the planned activity very responsibly, which is why we strongly recommend that you always have the latest standards with detailed technical characteristics and recommendations available.
EN ISO 5840-3:2021
Each standard has several parts in it. Sometimes each part can complement the previous ones and, when used together, create a fairly effective complex. But sometimes the whole standard can talk about one category that is included in the whole complex. A striking example is the refinement to the previous standard, or rather its previous part, by its addition to EN ISO 5840-3: 2021.
EN ISO 5840-2:2021
A large number of technological features, as well as clarification for each unique case, creates the need for the creation of a clear regulatory and legal explanation. Another important standard for the regulation of cardiac equipment is EN ISO 5840-2: 2021.
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.
If you have any questions about the difference between the three above-mentioned standards, you can always ask for help from a team of specialists in the field of selection of international standards and solve all your questions in order to avoid choosing the wrong document.
We have repeatedly discussed the need to standardize the metals used, but when it comes to the field of medicine, this topic is given increased importance and one of the documents regulating this issue is EN 14222: 2021.
This document specifies requirements for electrically heated steam boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar.
Detailed technical specifications and recommendations regarding medical equipment and processes for regulating their operation can be seen by clicking on the link to the site attached in the title of this document.
International technical standards and their importance
As already noted, there is a huge number of types of equipment used even in one category and its highly specialized branch. Nevertheless, each case in medicine is unique, and therefore requires both an integrated and a private approach at the same time. And the sale and production, as well as the operation of medical cardiological equipment at each of the mentioned stages is responsible for human life. That is why the presence of international standards will significantly protect you from making possible mistakes, and will also give you the opportunity to expand your scope not only to international markets, but also to declare the quality of your products or services at the global level.
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