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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: 2026-11-09
Description: Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)
Purpose: ISO 11137-1 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. This standard describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performed properly. Although the scope is limited to medical devices, ISO 11137-1 can be applied to other products and equipment. ISO 11137-1 covers radiation processes employing irradiators using: a) the radionuclide 60Co or 137Cs, b) a beam from an electron generator or c) a beam from an X-ray generator. ISO 11137-1 cannot be applied to processes for inactivating viruses or the causative agents of spongiform encep...
Official journal of: 2026-11-09
Description: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2025)
Purpose: ISO 80369-1 specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. It also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: — respiratory, — enteral, — limb cuff inflation, — neural, — intravascular or hypodermic, — other use cases utilising an ISO 80369-7 small-bore connector. ISO 80369-1 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or bet...
Official journal of: 2026-11-09
Description: Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
Purpose: The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered). These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.
Official journal of: 2026-11-09
Description: Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
Purpose: IEC 60601-2-57 applies to the basic safety and essential performance of equipment that incorporates one or more sources of optical radiation in the wavelength range from 200 nm to 3 000 nm. Laser radiation is excluded from the scope of this document. The equipment is intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications. Such equipment is referred to as light source equipment (LS equipment). The requirements of IEC 60601-2-57 represent the minimum necessary to achieve a reasonable level of safety and reliability. They apply to the operation and use of non-laser light source equipment intended for therapeutic, di...
Official journal of: 2026-11-09
Description: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Purpose: IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4. Medical Electrical Equipment or Medical Electrical Systems which incorporate lasers as sources of energy being transferred to the Patient or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. Laser Products for these applications classified as a Class 1, Class 1M, Class 2, Class 2M or Class 3R Laser Product, ar...
Official journal of: 2026-11-09
Description: Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO 15883-6:2026)
Purpose: This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD. The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces). NOTE Thermal disinfection can be achieved by rinsing the load with ...
Official journal of: 2026-11-09
Description: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)
Purpose: ISO 10993-7 specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices. It also defines procedures for measuring EO and ECH, as well as methods for determining conformity prior to device release. Additional background, including guidance and a flowchart showing how this standard is applied, are also included in Annexes A, B, C, D, E, F, G, H, I, J and K. EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this standard. ISO 10993-7 does not apply to devices that have been demonstrated to not absorb or retain EO or its degrad...
Official journal of: 2026-11-09
Description: Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2026)
Purpose: ISO 10993-6 specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This standard applies to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required. ISO 10993-6 applies to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products. These implantation tests are not intended...
Official journal of: 2026-11-09
Description: Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2026)
Purpose: This document specifies requirements and test methods for male condoms made from natural rubber latex. This document does not specify requirements related to any medicinal substances applied to or delivered by the condom. NOTE The safety and effectiveness of any medicinal substance are assessed according to national and regional regulations.
Official journal of: 2026-11-09
Description: Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
Purpose: ISO 14155 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this standard are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). ISO 14155 specifies general requirements intended to — protect the rights, safety and well-being of human subjects, — ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, — define the responsibi...
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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.
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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.