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This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity
HOW DOES IT WORK?View the latest standards
Official journal of: 2026-06-15
Description: Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Purpose: Amendment to EN ISO 15223-1:2021
Official journal of: 2026-06-11
Description: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Purpose: Amendment to EN 60601-1:2006
Official journal of: 2026-06-11
Description: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Purpose: EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is recognized that many items of medical electrical equipment and responsible organizations must depend on standards to ensure essential performance as well as basic safety. Such areas include the accuracy with which the equipment controls the delivery of energy or therapeutic substances to the patient, or processes and displays physiological data that will affect patient management. EN 60601-1 can also be applied to equipment used for compensation or alleviation of disease, injury or disability. For certain types of medical electrical equipment, these requirem...
Official journal of: 2026-06-11
Description: Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods (ISO 23908:2024)
Purpose: This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances. The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use. The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision. This document d...
Official journal of: 2026-06-11
Description: Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024)
Purpose: This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, this document specifies a static test procedure for p...
Official journal of: 2026-06-11
Description: Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)
Purpose: This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as: a) bed frames; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs; i) ...
Official journal of: 2026-06-11
Description: Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024)
Purpose: This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle. This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
Official journal of: 2026-06-11
Description: Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024)
Purpose: This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware. This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1. NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causati...
Official journal of: 2026-06-11
Description: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
Purpose: ISO 15883-1 specifies general performance requirements for washer-disinfectors (WD) and washer-disinfectors accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified. The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice. ISO 15...
Official journal of: 2026-06-11
Description: Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2025)
Purpose: This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses. This document takes precedence over the corresponding requirements of other standards, if differences exist.
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The "EU Declarations of conformity" web application also support mobile screen sizes, so you can access to your account everytime, everywhere.
The user interface is really intuitive; in this way, the user can enjoy the maximum experience even on a mobile device.
The EU declaration of conformity is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking he has manufactured. The declaration shall be in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates. Read more...
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This Application collects some Personal Data from its Users.
Among the types of Personal Data that this Application collects, by itself or through third parties, there are: Cookies; Usage Data.
Complete details on each type of Personal Data collected are provided in the dedicated sections of this privacy policy or by specific explanation texts displayed prior to the Data collection.
Personal Data may be freely provided by the User, or, in case of Usage Data, collected automatically when using this Application.
Unless specified otherwise, all Data requested by this Application is mandatory and failure to provide this Data may make it impossible for this Application to provide its services. In cases where this Application specifically states that some Data is not mandatory, Users are free not to communicate this Data without consequences to the availability or the functioning of the Service.
Users who are uncertain about which Personal Data is mandatory are welcome to contact the Owner.
Any use of Cookies – or of other tracking tools – by this Application or by the owners of third-party services used by this Application serves the purpose of providing the Service required by the User, in addition to any other purposes described in the present document and in the Cookie Policy, if available.
Users are responsible for any third-party Personal Data obtained, published or shared through this Application and confirm that they have the third party's consent to provide the Data to the Owner.
The Owner takes appropriate security measures to prevent unauthorized access, disclosure, modification, or unauthorized destruction of the Data.
The Data processing is carried out using computers and/or IT enabled tools, following organizational procedures and modes strictly related to the purposes indicated. In addition to the Owner, in some cases, the Data may be accessible to certain types of persons in charge, involved with the operation of this Application (administration, sales, marketing, legal, system administration) or external parties (such as third-party technical service providers, mail carriers, hosting providers, IT companies, communications agencies) appointed, if necessary, as Data Processors by the Owner. The updated list of these parties may be requested from the Owner at any time.
Legal basis of processingThe Owner may process Personal Data relating to Users if one of the following applies:
In any case, the Owner will gladly help to clarify the specific legal basis that applies to the processing, and in particular whether the provision of Personal Data is a statutory or contractual requirement, or a requirement necessary to enter into a contract.
PlaceThe Data is processed at the Owner's operating offices and in any other places where the parties involved in the processing are located.
Depending on the User's location, data transfers may involve transferring the User's Data to a country other than their own. To find out more about the place of processing of such transferred Data, Users can check the section containing details about the processing of Personal Data.
Users are also entitled to learn about the legal basis of Data transfers to a country outside the European Union or to any international organization governed by public international law or set up by two or more countries, such as the UN, and about the security measures taken by the Owner to safeguard their Data.
If any such transfer takes place, Users can find out more by checking the relevant sections of this document or inquire with the Owner using the information provided in the contact section.
Retention timePersonal Data shall be processed and stored for as long as required by the purpose they have been collected for.
Therefore:
The Owner may be allowed to retain Personal Data for a longer period whenever the User has given consent to such processing, as long as such consent is not withdrawn. Furthermore, the Owner may be obliged to retain Personal Data for a longer period whenever required to do so for the performance of a legal obligation or upon order of an authority.
Once the retention period expires, Personal Data shall be deleted. Therefore, the right to access, the right to erasure, the right to rectification and the right to data portability cannot be enforced after expiration of the retention period.
The Data concerning the User is collected to allow the Owner to provide its Services, as well as for the following purposes: Analytics and SPAM protection.
Users can find further detailed information about such purposes of processing and about the specific Personal Data used for each purpose in the respective sections of this document.
Personal Data is collected for the following purposes and using the following services:
The services contained in this section enable the Owner to monitor and analyze web traffic and can be used to keep track of User behavior.
Google Analytics (Google Ireland Limited)
Google Analytics is a web analysis service provided by Google Ireland Limited (“Google”). Google utilizes the Data collected to track and examine the use of this Application, to prepare reports on its activities and share them with other Google services.
Google may use the Data collected to contextualize and personalize the ads of its own advertising network.
Personal Data collected: Cookies; Usage Data.
Place of processing: Ireland – Privacy Policy. Privacy Shield participant.
This type of service analyzes the traffic of this Application, potentially containing Users' Personal Data, with the purpose of filtering it from parts of traffic, messages and content that are recognized as SPAM.
Google reCAPTCHA (Google Ireland Limited)
Google reCAPTCHA is a SPAM protection service provided by Google Ireland Limited.
The use of reCAPTCHA is subject to the Google privacy policy and terms of use.
Personal Data collected: Cookies; Usage Data.
Place of processing: Ireland – Privacy Policy. Privacy Shield participant.
Users may exercise certain rights regarding their Data processed by the Owner.
In particular, Users have the right to do the following:
Where Personal Data is processed for a public interest, in the exercise of an official authority vested in the Owner or for the purposes of the legitimate interests pursued by the Owner, Users may object to such processing by providing a ground related to their particular situation to justify the objection.
Users must know that, however, should their Personal Data be processed for direct marketing purposes, they can object to that processing at any time without providing any justification. To learn, whether the Owner is processing Personal Data for direct marketing purposes, Users may refer to the relevant sections of this document.
How to exercise these rightsAny requests to exercise User rights can be directed to the Owner through the contact details provided in this document. These requests can be exercised free of charge and will be addressed by the Owner as early as possible and always within one month.
The User's Personal Data may be used for legal purposes by the Owner in Court or in the stages leading to possible legal action arising from improper use of this Application or the related Services.
The User declares to be aware that the Owner may be required to reveal personal data upon request of public authorities.
In addition to the information contained in this privacy policy, this Application may provide the User with additional and contextual information concerning particular Services or the collection and processing of Personal Data upon request.
System logs and maintenanceFor operation and maintenance purposes, this Application and any third-party services may collect files that record interaction with this Application (System logs) use other Personal Data (such as the IP Address) for this purpose.
Information not contained in this policyMore details concerning the collection or processing of Personal Data may be requested from the Owner at any time. Please see the contact information at the beginning of this document.
How “Do Not Track” requests are handledThis Application does not support “Do Not Track” requests.
To determine whether any of the third-party services it uses honor the “Do Not Track” requests, please read their privacy policies.
The Owner reserves the right to make changes to this privacy policy at any time by giving notice to its Users on this page and possibly within this Application and/or - as far as technically and legally feasible - sending a notice to Users via any contact information available to the Owner. It is strongly recommended to check this page often, referring to the date of the last modification listed at the bottom.
Should the changes affect processing activities performed on the basis of the User’s consent, the Owner shall collect new consent from the User, where required.
Any information regarding a natural person, a legal person, an institution or an association, which is, or can be, identified, even indirectly, by reference to any other information, including a personal identification number.
Usage DataInformation collected automatically through this Application (or third-party services employed in this Application), which can include: the IP addresses or domain names of the computers utilized by the Users who use this Application, the URI addresses (Uniform Resource Identifier), the time of the request, the method utilized to submit the request to the server, the size of the file received in response, the numerical code indicating the status of the server's answer (successful outcome, error, etc.), the country of origin, the features of the browser and the operating system utilized by the User, the various time details per visit (e.g., the time spent on each page within the Application) and the details about the path followed within the Application with special reference to the sequence of pages visited, and other parameters about the device operating system and/or the User's IT environment.
UserThe individual using this Application who, unless otherwise specified, coincides with the Data Subject.
Data SubjectThe natural person to whom the Personal Data refers.
Data Processor (or Data Supervisor)The natural or legal person, public authority, agency or other body which processes Personal Data on behalf of the Controller, as described in this privacy policy.
Data Controller (or Owner)The natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of Personal Data, including the security measures concerning the operation and use of this Application. The Data Controller, unless otherwise specified, is the Owner of this Application.
This ApplicationThe means by which the Personal Data of the User is collected and processed.
ServiceThe service provided by this Application as described in the relative terms (if available) and on this site/application.
European Union (or EU)Unless otherwise specified, all references made within this document to the European Union include all current member states to the European Union and the European Economic Area.
This privacy policy relates solely to this Application.
CookiesSmall sets of data stored in the User's device.