Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 25.05.2019
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This document specifies requirements and test methods for endodontic instruments used as pluggers and spreaders, used to compact endodontic filling materials not cited in the other parts of the 3630 series.

This document specifies requirements for size, marking, product designation, safety considerations, and their labeling and packaging.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 25.05.2019
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This document specifies requirements and test methods for hand-held or mechanically operated shaping and cleaning instruments used to perform root canal procedures not cited in the other parts of the 3630 series.

This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 204 (Sterilization of medical devices)
Původce: CEN
K připomínkám do: 26.05.2019
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell based health care products.

This document does not specify requirements for restricted access barrier systems (RABS).

This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.

This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.

This International Standard does not define biosafety containment requirements.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 164 (Water supply)
Původce: CEN
K připomínkám do: 27.05.2019
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This document specifies:

a)     the field of application;

b)    the requirements of hose union anti vacuum valves;

c)     dimensional and physio-chemical properties, and properties of general hydraulic, mechanical and acoustic design of hose union anti-vacuum valves of nominal sizes DN 15 up to and including DN 25;

d)    marking and technical product information.

This document specifies the characteristics of hose union anti-vacuum valves of nominal size DN 15 up to and including DN 25 that are suitable for use in drinking water systems at pressures up to and including 1 MPa (10 bar) and temperatures up to and including 65 °C and for 1 h at 90 °C.

HB protects against back siphonage only and is installed in vertical downward flow position.

HB and HD anti-vacuum valves are for installation exclusively at the connecting point between stop valve and hose in vertical downward flow position.

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 211 (Acoustics)
Původce: CEN
K připomínkám do: 3.06.2019
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This document specifies a laboratory substitution method to determine the insertion loss without flow of ducted, mainly absorbent, circular and rectangular silencers, as well as other duct elements for use in ventilating and air-conditioning systems.

NOTE 1       Laboratory measurement procedures for ducted silencers with superimposed flow are described in ISO 7235.

This document is applicable to silencers where the design velocity does not exceed 15 m/s. As the method does not include self-generated flow noise, this document is not suitable for tests on silencers where this type of noise is of great importance for the evaluation of the silencer performance. As most silencers, particularly in offices and dwelling, have design velocities below 15 m/s this document can often be a cost efficient alternative to ISO 7235.

The insertion loss determined according to this document in a laboratory will not necessarily be the same as the insertion loss that will be obtained in an installation in the field. Different sound and flow fields in the duct will yield different results. In this document the sound field will be dominated by plane wave modes. As this document requires regular test ducts, the results may include some flanking transmission via structural vibrations in the duct walls, that sets an upper limit to the insertion loss that can be determined.

NOTE 2       ISO 7235 gives methods for determining this limit.

This document is intended to be used for circular silencers with diameters of 80 mm to 2000 mm or rectangular silencers with cross-sectional areas within the same range.

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
Původce: CEN
K připomínkám do: 11.06.2019
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This document specifies requirements for electrically heated shell boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.

This document covers only boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 17.06.2019
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This document provides test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials.

This document is not applicable to instruments and dental amalgam (see ISO TS 17988).

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 26.06.2019
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This international standard provides dentists and forensic dental experts with an organized system of concepts to describe the distinctive characteristics of an individual’s mouth. The chosen system is based on a forensic approach of a mouth’s characteristics, with many concepts specifics to the identification domain that are not defined elsewhere in ISO dentistry vocabularies (e.g. “present tooth”).

The hierarchical structure of the standard is designed to describe attributes of a tooth, the mouth and a prosthesis/orthosis with increasing levels of discriminative characteristics (e.g. material characteristics, restored tooth surface…) and the possibility to connect any level of description of an attribute with the most comprehensive concept.

This standard is intended to be used for data exchange between antemortem and postmortem files, without any ambiguity on the terms used to describe an individual’s mouth.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 26.06.2019
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This document specifies requirements and test methods for cartridge syringes used in dentistry which are reusable syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local anaesthetics.

This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.

This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 30.06.2019
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Part 2 of ISO 25539 specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

NOTE          Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.

The scope of this part of ISO 25539 is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this standard, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.

Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this standard, but test methods are not described for the combination. The preclinical in vivo and clinical evaluations of these stents may be addressed with the evaluations of the associated endovascular prosthesis in accordance with ISO 25539-1.

Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this standard. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539 (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).

Balloons integral to the stent system are within the scope of this standard. This part of ISO 25539 provides requirements beyond the requirements of ISO 10555-4 Intravascular catheters — Sterile and single-use catheters, specific to the use of balloons with vascular stents.

This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.

Tacking devices intended to spot treat post-angioplasy dissections, coil supporting devices, and flow diverters are within the scope of this standard, but comprehensive requirements and testing are not described for these devices.

Although drug-eluting stents are within the scope of this standard, this standard is not comprehensive with respect to the drug-eluting properties of these devices.

NOTE          Vascular device-drug combination products are within the scope of ISO 12417-1 Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products.

Although absorbable stents and stents with absorbable coatings are within the scope of this standard, this standard in not comprehensive with respect to the absorbable properties of these devices.

NOTE          Absorbable implants are within the scope of ISO/TS 17137 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants.

Although coated stents and coated stent systems are within the scope of this standard, this standard is not comprehensive with respect to coatings.

NOTE          Some coating properties are within the scope of ISO 17327-1 Non-active surgical implants — Implant coating — Part 1: General requirements.

This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 30.06.2019
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑12.

This document includes:

—    pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

—    details of in vitro and in vivo irritation test procedures;

—    key factors for the interpretation of the results.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex D several special in vivo irritation tests are described for application of medical devices in areas other than skin. In addition, Annex E provides information for conducting human skin irritation testing.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 30.06.2019
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This document specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological test systems onlyin accordance with one or more parts of ISO 10993. Specifically, this document addresses the following:

—    test sample selection;

—    selection of representative portions from a medical device;

—    test sample preparation;

—    experimental controls;

—    selection of, and requirements, for reference materials;

—    preparation of extracts.

This document is not applicable to live cells, but can be relevant to the material or medical device components of combination products containing live cells.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 2.07.2019
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This document specifies requirements, test methods, instructions for use and marking for multifunction handpieces (colloquially called “syringes”) intended to be used in the oral cavity of the patient. The multifunction handpieces are connected to dental units and provide the user with water, air and spray for treatment purposes. Some multifunction handpieces provide also illumination of the situs.

This document does not apply to dental handpieces and motors, dental turbines, intraoral cameras, contra angels, dental polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces, suction cannulas and saliva ejectors.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 5.07.2019
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This document specifies requirements and test methods for central compressed air source equipment supplying dental air for dental units and various dental air consuming devices in the dental office.

It also specifies quality requirements and test methods for the dental air produced by the central compressed air source equipment, such as requirements for the purity level of dental air.

It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central compressed air source equipment.

This document applies only to central compressed air source equipment located outside of the dental treatment room.

Central compressed air source equipment located in the dental treatment room and facility piping are excluded from the scope of this document.

This document does not include requirements for dental laboratory applications (e. g. CAD/CAM systems)

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 264 (Air quality)
Původce: CEN
K připomínkám do: 8.07.2019
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This document specifies the quality assurance and quality control procedures related to automated dust arrestment plant monitors.

This document applies to two types of instruments commonly used for dust arrestment plant control purposes:

—    filter dust monitors that are configured in mass concentration units (e.g. mg/m3) and is used for dust arrestment control purposes;

—    filter leakage monitors that indicate a change in the emission levels or a change in the magnitude of the dust pulses created by the cleaning process of the dust arrestment plant.

This document applies to instruments certified according to the requirements of EN 15859.

This document provides information on the configuration, ongoing quality assurance (with internal zero and reference checks) and annual surveillance tests of instruments. This ensures that the instrument is providing information to demonstrate that dust arrestment plant is working correctly and controlling dust pollution to the required levels.

The configuration of the alarm levels of filter dust monitors is performed by parallel measurements with the standard reference method in EN 13284‑1.

This document specifies the set-up of filter leakage monitors used to monitor a change in response caused by deterioration in the operation of the dust arrestment plant.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 9.07.2019
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This document specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic, rubber or other materials and intended for the filling and the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is automatically rendered unusable.

This document does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

This document is not applicable to syringes for use with insulin (specified in ISO 8537), syringes for use with power-driven syringe pumps (specified in ISO 7886‑2), reuse prevention syringes (specified in ISO 7886‑4) and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

NOTE          Prefilled syringes are covered in the ISO 11040‑ series.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 9.07.2019
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This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.

This document does not apply to syringes for use with insulin (specified in ISO 8537[2]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.