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This document 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 document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to:

 

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

 

This document 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 document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document 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 responsibilities of the sponsor and principal investigator, and — assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply. NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

 

This document specifies requirements and general principles governing the biological evaluation of medical devices within a risk management process per ISO 14971. This document applies to the evaluation of medical devices that have direct contact or indirect contact with either: Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with: The biological evaluation specified by this document can address the biological safety of the medical device throughout its life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This version of the standard does not mandate re-testing of medical devices that are already on the market and have established and acceptable safety profiles (see 6.6.2). This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conduct of a clinical trial. This means that principles outlined by this standard can be applied to evaluation of prototype or development stage devices as well as to finished medical devices. Other parts of ISO 10993 cover specific aspects of biological evaluation such as chemical characterisation, biological testing, sample preparations, animal welfare and toxicological risk assessment. For some types of medical devices, specific requirements from other standards (outside the ISO 10993-series) can be considered with justification for the approach taken in the event of differences between ISO 10993 requirements and those provided in other standards. For example, the ISO 18562 series of standards provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO 7405 provides specific requirements for biological evaluation of dental devices. The evaluation of risks related to infectious agents (e.g., bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents) is not within the scope of this document.

 

This Document defines a methodology to evaluate scenarios and provides a procedure extending test scenarios to test cases for a given function in a traceable way based on the testability. This Document also defines necessary characteristics of a test case that include but are not limited to unified identifier, test objective, inputs, steps, platform and expected results. This Document describes methods and criteria to evaluate the test case (e.g., frequency, criticality, complexity of a scenario), the coverage concerning functional and technical requirements, operational domain (OD) and test criteria, and also the optimizing of the set of prioritized test cases. This Document is applicable to Level 3 and higher ADS as defined in ISO/SAE PAS 22736.[1] The focus of this Document is on safety (Functional safety and Safety of the intended functionality (SOTIF)), in general the content is also applicable to non-safety relevant test scenarios.

 

This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

 

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

 

 

This document defines the requirements for developing and documenting the goals, limitations, target end users, and target patient population for Artificial Intelligence (AI) and Augmented Intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data, and annotation necessary for the software to ensure that it achieves its intended goals.

 

This document applies to software for 2D x ray image analysis in dental medicine, the basis of which is the application of artificial intelligence (AI). The scope of applicability of this document includes a) Software-as-a-Medical Device (SaMD) b) Software-in-a-Medical Device (SiMD) and c) Software to improve the efficiency of healthcare applications. This document applies to AI applications that learn statically and continuously/incrementally.

 

This document specifies requirements intended to ensure safety and health of persons using caravan holiday homes as defined in EN 13878, as temporary or seasonal accommodation. It specifies grades of resistance to snow loads and the stability of the structure of caravan holiday homes as well as the minimum information to be included in a user's handbook. It also specifies the corresponding test methods.

 

This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification. The requirements for the different classes are given in the respective parts of prEN 12469.

 

This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene. It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.

 

This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.

 

This document gives guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.

 

ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.

 

Specification of the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release. The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm-2·week-1 set forth by European Regulation [Regulation (EC) No 1907/2006, REACH, in particular Commission Regulation (EC) No 552/2009 of 22 June 2009 amending regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and restriction of Chemicals (REACH) as regards Annex XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES]. The standard applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. It also applies to those relevant metal parts of ready-towear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.

 

This document specifies the requirements for secured and unsecured diagnostic communication between client DoIP entity and server(s) installed in the vehicle using Internet protocol (IP) as well as the transmission control protocol (TCP) and user datagram protocol (UDP). This includes the definition of vehicle gateway requirements (e.g., for integration into an existing computer network) and test equipment (client DoIP entity) requirements (e.g., to detect and establish communication with a vehicle). This document specifies features that are used to detect a vehicle in a network and enable communication with the vehicle gateway as well as with its sub-components during the various vehicle states. These features are separated into two types: mandatory and optional. This document specifies the following mandatory features: This document specifies the following optional features:

 

This document specifies the competencies required of assistance dogs’ professionals. The purpose of this document is to improve and ensure the quality of professionals working in a role within an assistance dog organization. Each speciality of assistance dog requires a specific set of role competencies and there are some common core competencies. Core competencies: - breeding; - puppy raising; - dog care; - assessors; - orientation and mobility; - trainers; - instructors. Specific competencies: - guide dogs; - hearing dogs; - medical alert dogs; - mobility assistance dogs; - autism and development disorder dogs; - team training instructor. It is accepted that assistance dog organisations vary greatly in structure and not every organization will have all the roles identified. Where one person performs more than one role, it is expected that they will have the competencies of all the roles they perform e.g. a dog trainer may also have the competencies of a dog care specialist. And there will be some organisations where some of these roles are not required, e.g. those with no breeding programme will not require the associated role competencies.

 

ISO 19490:2017 specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.