Hälso- och sjukvård

This document addresses good clinical practice for the design, conduct, recording and reporting of pre-market clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

The principles set forth in this document also apply to post-market clinical investigations and should be followed as far as relevant, considering the nature of the clinical investigation and the requirements of national regulations (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 This standard can be used for regulatory purposes.

NOTE 2 Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.

NOTE 3 For Software as a Medical Device (SaMD), justifications for exemptions of this standard can consider the uniqueness of indirect contact between subjects and the SaMD. However it is required to demonstrate 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 (see Reference [5]).

This document does not apply to in vitro diagnostic medical devices.

This part of ISO 20776 describes one reference method, broth micro-dilution, for determination of MICs. The MIC may be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as “susceptible” (S), “intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this part of ISO 20776, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate Annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this document are applicable to all stages of the life-cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as for example those related to biocompatibility, data and systems security, electricity, moving parts, radiation, usability, and other risks.

This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure. This document does also not apply to business risk management.

This document does not specify acceptable risk levels, but requires manufacturers to establish objective criteria for risk acceptability.

This document does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

NOTE Guidance on the application of this document can be found in ISO/TR 24971 [9].

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.

With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.

This patt of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickelchromium- molybdenum alloy for use in the manufacture of surgical implants.

NOTE - The mechanical properties of a Sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.

This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.

NOTE The mechanical properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

The method described is designed to determine the disinfectant activity of processes used in the 1) human health, 2) veterinary, 3) food, industrial and institutional sectors using chemical processes.

The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document.

The test methods and volumes described provide the defined challenge. Even if an automated airborne disinfection system has passed all or part of the test described here, the system and its delivered cycles should then be validated in the individual enclosure to be disinfected using appropriate biological or chemical indicators.

This document describes a Phase 2 step 2 methods designed:

— to check, under standardized laboratory conditions approaching real-world practice, that the proposed airborne surface disinfection processes meet the objective for which they were devised;

— to cross-compare the different processes under reproducible conditions;

— to provide an experimental design within specified boundaries when real-world-practice conditions depart from the conditions given in the text below.

The method is applicable to processes to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas (WG1, WG2 and WG3).

It applies to the process of whole enclosure / room disinfection achieved by automated processes (i.e. with no operator manually applying the disinfectant). This document covers the disinfection of nonporous surfaces but not that of air;

This method can be used as a basis for biosecurity applications in laboratories.

The method is used to qualify the process, i.e. the set of components and consumables needed for implementation. By way of example, for chemical processes, the device product combination cannot be separated.

This document is applicable to processes for which activity is claimed against the following categories of microorganisms:

— vegetative bacteria including mycobacteria,

— bacterial spores,

— yeasts,

— fungal spores and,

— viruses.

Each activity can be claimed independently but passing both bactericidal and yeasticidal activity as per text in Annex A tests is the minimum requirement to claim compliance.

An activity tested for each domain of application may only be claimed if the criteria are achieved against all of the specified organisms associated with that activity.

The proposed method includes 2 parts:

— Part 1 - Efficacy test: intended to ensure that minimal efficacy requirements are obtained for each type of activity claimed and for the targeted application(s) (WG1 and/or WG2 and/or WG3).

— Part 2 - Distribution test: intended to ensure efficacy of the process throughout the enclosure. It is performed with a reference microorganism at 4 sampling positions.

The tests described in this document are based on measuring the logarithmic reduction of different species of bacteria, yeasts, moulds, bacterial spores, bacteriophages or viruses and mycobacteria under a specified set of conditions. As the panel of microorganisms selected may prove to be too narrow for certain applications, it may be supplemented by other strains based on the experimental design described in this document, by varying the conditions according to the needs of the practical application(s) envisaged.

For the defined test conditions the number of test position of the carriers can be increased according to specific needs of a given application or local requirements.

The manufacturer:

— specifies the limitations for use and precautions for use of the process;

— ensures that the documented test conditions are representative of the recommended practice(s).

The aim of this document is to simulate practical conditions of airborne disinfection in a laboratory situation; obligatory conditions are defined according to the method defined below. Additional conditions are also proposed.

The test report specifies and summarizes the conditions under which the tests are carried out.

The processes are generally implemented after a cleaning procedure and are then tested, according to the application sectors, under clean or low-level soiling conditions. For some specific applications, and according to the manufacturer's recommendations, evaluation methods in the presence of other interfering substances can also be envisaged under additional conditions.