Obecné normy

Oblast zaměření: Struktura povrchu
Komise : CEN/TC 290 (Dimensional and geometrical product specification and verification)
Původce: CEN
K připomínkám do: 20.08.2018
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This document specifies acceptance and periodic reverification tests of CMM performance with contacting probing systems and is only applicable to CMMs using:

—    any type of contacting probing system, and

—    spherical or hemispherical stylus tip(s).

NOTE          CMM probing performance tests are specified by the maximum permissible errors (MPEs), due to the impracticality of isolating the performance of the probing system from that of the CMM, even on a small artefact such as a test sphere.

This document applies to CMMs supplied with any of the following:

a)     single-stylus probing system;

b)    multi-stylus probing systems with fixed multiple styli attached to a single probe (e.g. “star” stylus);

c)     multiple probing systems such as those with a stylus for each of their probes;

d)    systems with articulating probing systems;

e)     stylus and probe changing systems;

f)     manual (non-driven) as well as automated CMMs;

g)     installations including a scanning probe and capable of being used in a scanning measuring mode.

This document is not applicable to non-contacting probing systems, which require different testing procedures.

The terms “multi-stylus size error”, etc., should strictly be written “combined CMM and multi-stylus probing- system size error”, etc. For convenience, the wording has been truncated.

If it is desired to isolate the probing-system performance as far as is practical, the influence of the CMM can be minimized but not eliminated. See Annex C for more information.

Oblast zaměření: Zkoušení materiálu obecně
Komise : CEN/TC 138 (Non-destructive testing)
Původce: CEN
K připomínkám do: 11.09.2018
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This document specifies methods and acceptance criteria for assessing the electrical performance of digital ultrasonic instruments for pulse operation using A-scan display, operating within the frequency range 0,5 MHz to 15 MHz, for manual ultrasonic non-destructive testing with single or dual-element probes. This document is applicable for multi-channel instruments also. This document may partly be applicable to ultrasonic instruments in automated systems but then other tests can be needed to ensure satisfactory performance.

Ultrasonic instruments for continuous waves are not included in this document.

Ultrasonic phased array instruments are not included in this document, see e. g. ISO 18563-1. If a phased array instrument has dedicated connectors for single or dual-element probes this document is applicable for these channels.

Oblast zaměření: Zkoušení materiálu obecně
Komise : CEN/TC 138 (Non-destructive testing)
Původce: CEN
K připomínkám do: 11.09.2018
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This document describes methods, tolerances and acceptance criteria for verifying the performance of combined ultrasonic test equipment (i.e. instrument, probes and cables connected) by the use of appropriate standard calibration blocks.

These methods are specifically intended for manual test equipment, i.e. digital ultrasonic instruments according to ISO 22232‑1 for manual ultrasonic non-destructive testing with single or dual-element probes according to ISO 22232‑2. This document is applicable for multi-channel instruments also. For automated test equipment different tests can be needed to ensure satisfactory performance.

These methods are not intended to prove the suitability of the equipment for particular applications. The methods described are suitable for the use by operators working under site or shop floor conditions.

Ultrasonic instruments for continuous waves are not included in this document.

Ultrasonic phased array systems are not included in this document, see e. g. ISO 18563‑3. If a phased array instrument is used in combination with single or dual-element probes this document is applicable for this combination.

Oblast zaměření: Zkoušení materiálu obecně
Komise : CEN/TC 138 (Non-destructive testing)
Původce: CEN
K připomínkám do: 11.09.2018
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This document covers probes used for non-destructive ultrasonic testing in the following categories with centre frequencies in the range 0,5 MHz to 15 MHz, focusing or without focusing means:

a)     single- or dual-transducer contact probes generating longitudinal or transverse waves;

b)    single-transducer immersion probes.

Where material-dependent ultrasonic values are specified in this document they are based on steels having a sound velocity of (5 920 ± 50) m/s for longitudinal waves, and (3 255 ± 30) m/s for transverse waves.

Periodic tests for probes are not included in this document. Routine tests for the verification of probes using on-site methods are given in ISO 22232-3.

If parameters in addition to those specified in ISO 22232-3 are to be verified during the probe’s life time, as agreed upon by the contracting parties, the methods of verification for these additional parameters should be selected from those given in this document.

Ultrasonic phased array probes are not included in this document, see ISO 18563-2.

Oblast zaměření: Optika
Komise : CEN/TC 170 (Ophthalmic optics)
Původce: CEN
K připomínkám do: 22.09.2018
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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.

Oblast zaměření: Prokazování kvality
Komise : CEN/CLC/JTC 1 (Criteria for conformity assessment bodies)
Původce: CEN
K připomínkám do: 25.09.2018
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This Technical Specification complements the existing requirements of ISO/IEC 17021. It includes specific competence requirements for personnel involved in the certification process for quality management systems (QMS).

NOTE          This Technical Specification is applicable for auditing and certification of a QMS based on ISO 9001. It can also be used for other QMS applications.

Oblast zaměření: Systémy zpracování informací
Komise : CEN/TC 251 (Health informatics)
Původce: CEN
K připomínkám do: 25.09.2018
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This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of healthcare. It is specifically aimed at supporting ‘unplanned, cross-border care’ and is intended to be an international patient summary (IPS).  The data set is minimal and non-exhaustive, providing a robust, well-defined core set of data items. This tight focus paradoxically enables the specified data items to also be used in planned care, and for both unplanned and planned care to be supported by this data set within local and national contexts, thereby increasing its utility and value.

It uses the European Guidelines (eHN version 2, November 2016) as the initial source for the patient summary requirements but takes into consideration other international efforts so as to provide an interoperable data set specification for global application.

This IPS standard provides an abstract definition of a Patient Summary from which derived models are implementable.  Due to its nature therefore, readers should be aware that the compliance with this standard doesn’t imply automatic technical interoperability; this result, enabled by this standard, can be reached with the conformity to standards indicated in the associated technical specifications.

This international standard does not cover workflow processes of data entry, data collection, the summarization act itself nor subsequent data presentation, nor assimilation, nor aggregation.

It is not an implementation guide that is concerned with the various technical layers beneath the application layer.  Implementation guidance for specifically jurisdictional concerns, e.g. Directives, terminologies, formats etc., is specified in associated Technical Specifications.

In particular, representation by various coding schemes, additional structures and terminologies are not part of this standard.  Terminology and its binding are addressed in the associated Technical Specifications and comprise part of the Guidance for IPS implementation. The Identification of Medicinal Products standards (abbreviated to IDMP) are the recommended target for the Medication Summary related to this standard but, prior to IDMPs’ full implementation in practice, this IPS standard cannot insist in its use at this point in time and recognizes that interim schemes may be necessary until IDMP becomes the norm.

Oblast zaměření: Měřidla
Komise : CEN/TC 318 (Hydrometry)
Původce: CEN
K připomínkám do: 1.10.2018
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This document considers liquid atmospheric precipitation and defines the procedures and equipment to perform laboratory and field tests, in steady-state conditions, for the calibration, check and metrological confirmation of liquid precipitation measurement instruments. It provides a classification of catching-type measurement instruments based on their laboratory performance. The classification does not relate to the physical principle used for the measurement, nor does it refer to the technical characteristics of the instrument assembly, but is solely based on the instrument calibration. Attribution of a given class to an instrument is not intended as a high/low ranking of its quality but rather as a quantitative standardized method to declare the achievable measurement accuracy in order to provide guidance on the suitability for a particular purpose, while meeting the user’s requirements.

Oblast zaměření: Systémy zpracování informací
Komise : CEN/TC 278 (Intelligent transport systems)
Původce: CEN
K připomínkám do: 1.10.2018
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The present document defines the architecture of toll system environments in which a customer with one contract may use a vehicle in a variety of toll domains and with a different Toll charger for each domain.

Toll systems conforming to the present document may be used for various purposes including road (network) tolling, area tolling, collecting fees for the usage of bridges, tunnels, ferries, for access or for parking. From a technical point of view the considered toll systems use electronic equipment on board of a vehicle.

From a process point of view the architectural description focuses on toll determination, toll charging, and the associated enforcement measures. The actual collection of the toll, i.e. collecting payments, is outside of the scope of the present document.

The architecture in the present document is defined with no more details than those required for an overall overview, a common language, an identification of the need for and interactions among other standards, and the drafting of these standards.

The present document as a whole provides:

—    The enterprise view on the architecture, which is concerned with the purpose, scope and policies governing the activities of the specified system within the organization of which it is a part.

—    Terms and definitions for common use in a toll environment

—    A decomposition of the toll systems environment into its main enterprise objects

—    The roles and responsibilities of the main actors

—    Identification of the provided services by means of action diagrams that underline the needed standardised exchanges

—    Identification of the interoperability interfaces for EFC systems, to be specified in specialised standards.

Oblast zaměření: Systémy zpracování informací
Komise : CEN/TC 251 (Health informatics)
Původce: CEN
K připomínkám do: 1.10.2018
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This document specifies the common conventions required for the interchange of specific patient data (demographic, recording conditions ...), ECG signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results.

This document specifies the content and structure of the information which is to be interchanged between digital ECG electrocardiographs/devices and computer ECG management systems, as well as other computer or information systems (cloud, etc.) where ECG data can be stored.

This document defines the way to describe and encode standard and medium to long-term electrocardiogram waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups, ambulatory and home care. It covers electrocardiograms such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, Holter ECGs and exercise ECGs that are recorded, measured and analysed by equipment such as electrocardiographs, patient monitors, wearable devices. It also covers intracardiac electrograms recorded by implantable devices as well as the analysis results of ECG analysis and interpretation systems and software that are compatible with SCP-ECG.

ECG waveforms and data that are not in the scope of this technical specification include real-time ECG waveform encoding and analysis used for physiological monitors, and intra-cardiac or extra cardiac ECG mapping.