11 TERVISEHOOLDUS

Tagasi peagrupi juurde

Uued standardid

EVS-EN 1865-4:2012
Hind 6,47 EUR
Kiirabiautodes kasutatavad patsiendi transpordi abivahendid. Osa 4: Kokkupandav patsiendi transporditool
This European Standard defines the minimum requirements for the design and performance of foldable patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.

EVS-EN 61217:2012
Hind 19,05 EUR
Röntgenteraapia aparatuur. Koordinaadid, mehhanismid ja astmikud
This International Standard applies to equipment and data related to the process of TELERADIOTHERAPY, including PATIENT image data used in relation with RADIOTHERAPY TREATMENT PLANNING SYSTEMS, RADIOTHERAPY SIMULATORS, isocentric GAMMA BEAM THERAPY EQUIPMENT, isocentric medical ELECTRON ACCELERATORS, and non-isocentric equipment when relevant. The object of this standard is to define a consistent set of coordinate systems for use throughout the process of TELERADIOTHERAPY, to define the marking of scales (where provided), to define the movements of ME EQUIPMENT used in this process, and to facilitate computer control when used.

EVS-EN 60731:2012
Hind 22,15 EUR
Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
This International Standard specifies the performance requirements of RADIOTHERAPY DOSIMETERS, intended for the measurement of ABSORBED DOSE TO WATER or AIR KERMA (and their rates and spatial distributions) in PHOTON, ELECTRON, proton or heavy ion RADIATION FIELDS as used in RADIOTHERAPY. The DOSE MONITORING SYSTEMS incorporated in RADIOTHERAPY treatment machines are not covered by this standard, neither are the re-entrant IONIZATION CHAMBERS used for BRACHYTHERAPY source calibration and constancy check devices. This standard is applicable to the following types of dosimeter: a) FIELD-CLASS DOSIMETERS normally used for 1) the measurement of KERMA or dose in a RADIATION BEAM, either in air or in a PHANTOM; 2) in vivo skin surface or intracavitary measurements of dose on PATIENTS. b) REFERENCE-CLASS DOSIMETERS normally used for the calibration of FIELD-CLASS DOSIMETERS; NOTE REFERENCE-CLASS DOSIMETERS may be used as FIELD-CLASS DOSIMETERS. c) SCANNING-CLASS DOSIMETERS normally used for relative dose distribution measurements with a SCANNING SYSTEM such as an automatic water PHANTOM.

ISO 12870:2012
Hind 100,36 EUR
Ophthalmic optics -- Spectacle frames -- Requirements and test methods


ISO 21672-1:2012
Hind 60,88 EUR
Dentistry -- Periodontal probes -- Part 1: General requirements


ISO 11040-6:2012
Hind 54,29 EUR
Prefilled syringes -- Part 6: Plastic barrels for injectables


ISO 19980:2012
Hind 88,85 EUR
Ophthalmic instruments -- Corneal topographers


ISO 11608-1:2012
Hind 115,17 EUR
Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems


ISO 11608-2:2012
Hind 75,68 EUR
Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles


ISO/TS 23810:2012
Hind 54,29 EUR
Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup


ISO 6474-2:2012
Hind 60,88 EUR
Implants for surgery -- Ceramic materials -- Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement


ISO/IEC 29136:2012
Hind 95,43 EUR
Information technology -- User interfaces -- Accessibility of personal computer hardware


ISO/TS 10974:2012
Hind 195,79 EUR
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device


ISO 13926-3:2012
Hind 47,71 EUR
Pen systems -- Part 3: Seals for pen-injectors for medical use


EVS-EN ISO 11608-2:2012
Hind 11,67 EUR
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. It is not applicable to: - needles for dental use; - pre-filled syringe needles; - needles pre-assembled by the manufacturer; - needles not requiring assembly or attachment to the NIS.

EVS-EN ISO 11608-1:2012
Hind 16,10 EUR
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user. Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively. Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.

EVS-EN ISO 11137-2:2012
Hind 20,74 EUR
Tervishoiutoodete steriliseerimine. Kiirgus. Osa 2: Steriliseerimisdoosi määramine (ISO 11137-2:2012)
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

EVS-EN ISO 21672-1:2012
Hind 8,72 EUR
Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012)
This part of ISO 21672 specifies general requirements and test methods for periodontal probes. It is applicable to periodontal probes made of austenitic and martensitic stainless steel. It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force.

EVS-EN ISO 19980:2012
Hind 12,51 EUR
Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
This International Standard specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this International Standard and thus qualifies as a CT according to this International Standard. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This International Standard defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This International Standard is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. It is not applicable to ophthalmic instruments classified as ophthalmometers.

EVS-EN ISO 12870:2012
Hind 14,69 EUR
Oftalmiline optika. Prilliraamid. Nõuded ja katsemeetodid (ISO 12870:2012)
This International Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer. This International Standard is applicable to all spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames. It is also applicable to spectacle frames made from natural organic materials. NOTE See Annex A for recommendations on the design of spectacle frames. This International Standard is not applicable to complete custom-made spectacle frames or to products designed specifically to provide personal eye protection.

EVS-EN ISO 13485:2012
Hind 22,15 EUR
Meditsiiniseadmed. Kvaliteedijuhtimissüsteem. Normatiivsed nõuded
See rahvusvaheline standard täpsustab kvaliteedijuhtimissüsteemi nõudeid, kus organisatsioon peab näitama oma suutlikkust pakkuda meditsiiniseadmeid ja seotud teenuseid, mis vastavad järjekindlalt kliendi nõuetele ja normatiivsetele nõuetele, mida rakendatakse meditsiiniseadmetele ja seotud teenustele. Selle rahvusvahelise standardi esmane eesmärk on lihtsustada meditsiiniseadmete kvaliteedijuhtimissüsteemide ühtlustatud normatiivseid nõudeid. Selle tulemusena sisaldab see mõnda konkreetset meditsiiniseadmete kohta käivat normatiivset nõuet ja jätab välja mõned normatiivseteks nõueteks mittesobivad standardi ISO 9001:2000 nõuded. Nende väljajätmiste tõttu ei saa organisatsioonid, kelle kvaliteedijuhtimissüsteem on vastavuses selle rahvusvahelise standardiga, taotleda vastavust standardile ISO 9001:2000, kuni nende kvaliteedijuhtimissüsteem on vastavuses kõigi standardi ISO 9001:2000 nõuetega (vt lisa B).
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).

EVS-EN 60601-1:2006+A11:2011/AC:2012
Hind 0,00 EUR
Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele
Parandus standardi EVS-EN 60601-1:2006+A11:2011 eestikeelsele väljaandele
Corrigendum to EVS-EN 60601-1:2006+A11:2011 Estonian version

Asendatud või tühistatud standardid

EVS-EN 60731:2002/A1:2003
Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
This international Standard specifies the performance requirements or radiotherapy dosimeters, as defined in 3.1, intended for the measurement of absorbed dose to water or air kerma (and their rates) in photon or electron radiation fields as used in radiotherapy.
Keel: Inglise

EVS-EN 60731:2002
Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
This international Standard specifies the performance requirements or radiotherapy dosimeters, as defined in 3.1, intended for the measurement of absorbed dose to water or air kerma (and their rates) in photon or electron radiation fields as used in radiotherapy.
Keel: Inglise

EVS-EN ISO 11137-2:2007
Tervishoiutoodete steriliseerimine. Kiirgus. Osa 2: Steriliseerimisdoosi määramine
This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
Keel: Inglise

EVS-EN ISO 11608-2:2001
Pen-injectors for medical use - Part 2: Needles - Requirements and test methods
This International Standard specifies requirements and test methods for single use, double ended, sterile needles for pen-injectors which fulfil the specifications of ISO 11608-1.
Keel: Inglise

EVS-EN ISO 13485:2004
Meditsiiniseadmed. Kvaliteedijuhtimissüsteem. Normatiivsed nõuded
Standard täpsustab kvaliteedijuhtimissüsteemi nõudeid, kus organisatsioon peab näitama oma suutlikkust pakkuda meditsiiniseadmeid ja seotud teenuseid, mis vastavad järjekindlalt kliendi nõuetele, ja reguleerivaid sätteid, mida rakendatakse meditsiiniseadmetele ja seotud teenustele.
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Keel: Eesti, Inglise

EVS-EN ISO 19980:2005
Ophthalmic instruments - Corneal topographers
This International Standard is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye.
Keel: Inglise

EVS-EN ISO 11608-1:2001
Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods
This International Standard specifies requirements and test methods for pen-injectors intended to be used with needles and with replaceable or non-replaceable prefilled cartridges. Pen-injectors which are not electrically driven, but are equipped with electronic components.
Keel: Inglise

EVS-EN ISO 11137-2:2007/AC:2009
Tervishoiutoodete steriliseerimine. Kiirgus. Osa 2: Steriliseerimisdoosi määramine

Keel: Inglise

EVS-EN ISO 12870:2009
Oftalmiline optika. Prilliraamid. Nõuded ja katsemeetodid
Käesolev rahvusvaheline standard esitab põhinõuded klaasimata prilliraamidele, mis on ette nähtud kasutamiseks koos kõigi väljakirjutatud klaasidega, k.a. toonitud ja toonimata klaasid, ning kehtib jaemüügikohtade kaupmeestele.
This International Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses, and is applicable to frames at the point of sale to the retailer, by the manufacturer or supplier. It is applicable to all spectacle frame types including rimless mounts, semi-rimless mounts and folding spectacle frames. This International Standard is applicable to spectacle frames made from natural organic materials.
Keel: Inglise

ISO/TS 23810:2006
Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup

Keel: Inglise

ISO 11608-2:2000
Pen-injectors for medical use -- Part 2: Needles -- Requirements and test methods

Keel: Inglise

ISO 12870:2004
Ophthalmic optics -- Spectacle frames -- Requirements and test methods

Keel: Inglise

ISO 11608-1:2000
Pen-injectors for medical use -- Part 1: Pen-injectors -- Requirements and test methods

Keel: Inglise

ISO 19980:2005
Ophthalmic instruments -- Corneal topographers

Keel: Inglise

EVS-EN ISO 13485:2004/AC:2009
Meditsiiniseadmed. Kvaliteedijuhtimissüsteem. Normatiivsed nõuded

Keel: Eesti, Inglise

EVS-EN 61217:2010
Röntgenteraapia aparatuur. Koordinaadid, mehhanismid ja astmikud
This International Standard applies to equipment and data related to the process of tele-radiotherapy, including patient image data used in relation with radiotherapy treatment planning systems, radiotherapy simulators, isocentric gamma beam therapy equipment, isocentric medical electron accelerators, and non-isocentric equipment when relevant.
Keel: Inglise

EVS-EN 61217:2010/A1:2010
Röntgenteraapia aparatuur. Koordinaadid, mehhanismid ja astmikud
This International Standard applies to equipment and data related to the process of tele-radiotherapy, including patient image data used in relation with radiotherapy treatment planning systems, radiotherapy simulators, isocentric gamma beam therapy equipment, isocentric medical electron accelerators, and non-isocentric equipment when relevant.
Keel: Inglise

EVS-EN 61217:2010/A2:2010
Röntgenteraapia aparatuur. Koordinaadid, mehhanismid ja astmikud
This International Standard applies to equipment and data related to the process of tele-radiotherapy, including patient image data used in relation with radiotherapy treatment planning systems, radiotherapy simulators, isocentric gamma beam therapy equipment, isocentric medical electron accelerators, and non-isocentric equipment when relevant.
Keel: Inglise

Kavandite arvamusküsitlus

FprEN 60601-1-2
Tähtaeg 30.06.2012
Elektrilised meditsiiniseadmed. Osa 1-2: Üldnõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektromagnetiline ühilduvus. Nõuded ja katsetused
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. Specifically, this collateral standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES of ME EQUIPMENT and ME SYSTEMS. Applicability of this collateral standard includes ME EQUIPMENT and ME SYSTEMS that have been found to have no ESSENTIAL PERFORMANCE. BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES shall be evaluated for all ME EQUIPMENT and ME SYSTEMS.
Keel: Inglise

EN ISO 13408-6:2011/prA1
Tähtaeg 30.06.2012
Tervishoiutoodete aseptiline töötlemine. Osa 6: Isolaatorsüsteemid (ISO 13408-6:2005/DAM 1:2012)
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
Keel: Inglise

EN ISO 8359:2009/FprA1
Tähtaeg 30.06.2012
Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/FDAM 1:2012)
This International Standard specifies safety requirements for continuous-flow oxygen concentrators, as defined in 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators in- tended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.
Keel: Inglise

prEN ISO 5356-1
Tähtaeg 30.06.2012
Anesteesia- ja hingamisaparatuur. Koonilised konnektorid. Osa 1: Koonused ja pesad (ISO/DIS 5356-1:2012)
This part of ISO 5356 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic-gas scavenging systems and vaporizers. This part of ISO 5356 gives requirements for the following conical connectors: - 8,5 mm size intended for use in paediatric breathing systems; - 15 mm and 22 mm sizes intended for general use in breathing systems; - 22 mm latching connectors (including performance requirements); - 23 mm size intended for use with vaporizers, but not for use in breathing systems; - 30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system. This part of ISO 5356 does not specify the medical devices and accessories on which these connections are to be provided. Requirements for the application of conical connectors are not included in this part of ISO 5356, but are or will be given in the relevant International Standards for specific medical devices and accessories.
Keel: Inglise

prEN ISO 16498
Tähtaeg 30.06.2012
Dentistry - Minimal dental implant data set for clinical use (ISO/DIS 16498:2012)
This International Standard specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient’s jaw(s). The final prosthesis is excluded. This information will be recorded by the responsible clinician in the patient's file and should be made available to the patient by the clinician(s) who provided the care.
Keel: Inglise

FprEN ISO 11073-10421
Tähtaeg 30.06.2012
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO/FDIS 11073-10421:2012)
The scope of this standard is to establish a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case.
Keel: Inglise