Useful definitions

A collection of weakly or medium strongly bound particles where the resulting external surface area is similar to the sum of the surface areas of the individual components.

A particle comprising strongly bonded or fused particles where the resulting external surface area is significantly smaller than the sum of surface areas of the individual components.

Material, sufficiently homogeneous and stable with respect to one or more specified properties, established to be fit for its intended use in a measurement process. Certified RMs are accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability, ensuring traceability to the international system of units (SI) or specific, internationally agreed units, such as biologicals.

Measurements that corroborate each other to support the same decision.

An identifiable, integral component of a larger particle.

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) of the EC directive 2011/696/EU and of those referred to in the first paragraph of this point.

Note 1 to entry: For medical devices, the definition of nanomaterial of the EC directive 2011/696/EU and its revisions apply.

[SOURCE: Medical Device Regulation (EU) 2017/745]

A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action.

[SOURCE]

property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty

[REF.]

Currently a formal definition of nanomedicines does not exist. ETPN defines Nanomedicine as the application of nanotechnology to achieve innovation in healthcare. The European medical agency (EMA) has established a working definition for nanomedicines, based on following considerations: (i)Purposely designed systems for clinical applications; (ii) At least one component at nano-scale size that should not exceed 1000 nm; (iii) resulting in definable specific properties and characteristics

Note 1 to entry: For pharmaceutical products, both EMA and the US Food and Drug Administration (FDA) consider an extended definition of nano-materials, including sizes not exceed 1000 nm.

[SOURCE: The REFINE white paper]

Orthogonal Measurements: Measurements that use different physical principles to measure the same property of the same sample with the goal of minimising method-specific biases and interferences.

[REF.]

Minute piece of matter with defined physical boundaries.

Material, sufficiently homogeneous and stable with respect to one or more specified properties, which enable concluding on the conformance of the product being tested with the requirements set forth in the corresponding Ph. Eur. text.

Original source particle of agglomerates or aggregates or mixtures of the two.

Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process. Certified reference material (RM) are accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability. They ensure results are traceable to the international system of units (SI) or specific, internationally agreed units, e.x. biologicals.