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Uued standardid


EVS-EN ISO 10993-6:2016
Hind 15,40 EUR
Identne ISO 10993-6:2016; EN ISO 10993-6:2016
Meditsiiniseadmete bioloogiline hindamine. Osa 6: Katsed implantatsioonijärgsete paiksete toimete hindamiseks
ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. ISO 10993-6:2016 applies to materials that are - solid and non-absorbable, - non-solid, such as porous materials, liquids, gels, pastes, and particulates, and - degradable and/or absorbable, which may be solid or non-solid. The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined. ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.

EVS-EN ISO 3964:2016
Hind 9,49 EUR
Identne EN ISO 3964:2016; ISO 3964:2016
Dentistry - Coupling dimensions for handpiece connectors (ISO 3964:2016)
This International Standard describes the coupling between handpieces and motors connected to dental units. This International Standard specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motors which supply the handpiece with water, air and light and rotation energy.

EVS-EN ISO 9173-1:2016
Hind 7,38 EUR
Identne ISO 9173-1:2016; EN ISO 9173-1:2016
Dentistry - Extraction forceps - Part 1: General requirements (ISO 9173-1:2016)
ISO 9173-1:2016 specifies the general performance requirements for extraction forceps used in dentistry.

EVS-EN 50527-1:2016
Hind 14,69 EUR
Identne EN 50527-1:2016
Elektromagnetväljade mõju hindamine aktiivseid implanteeritavaid meditsiiniseadmeid kandvate töötajate korral. Osa 1: Üldine
This European Standard provides a procedure to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace. It describes how a general risk assessment should be performed and determines whether it is necessary to carry out a detailed risk assessment. NOTE 1 This European Standard does not cover indirect effects caused by non active implants. NOTE 2 The risk of human exposure to EMF considered is only due to malfunctioning of AIMD. Possibilities of AIMD contribution to the risk, e.g. local modification of the distribution of EMF produced by external source or production of own EMF, are covered by the respective product standards for the AIMD. Based on specific workplace standards it can be determined whether preventive measures/actions need to be taken to comply with the provisions of Directive 2013/35/EU. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of the normal work. The frequencies covered are from 0 Hz to 300 GHz. The European Parliament and Council Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. It is recommended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard and take precedence. NOTE 3 Performance requirements with respect to active implantable medical devices are excluded from the Scope of this standard. These are defined in the relevant particular standards for active implantable medical devices. The risk assessment described in this standard is only required if an AIMD-Employee is present. Active Implantable Medical Devices (AIMDs) are regulated by Directive 90/385/EEC and the amendments to it. NOTE 4 Product standards EN 45502-1 and of the EN 45502-2-X series describe the product requirements for different kinds of AIMDs. Different kinds of AIMDs are e.g. pacemaker (EN 45502-2-1), implantable cardioverter defibrillators (EN 45502-2-2), cochlear implants (EN 45502-2-3), implantable neurostimulators (ISO 14708-3), implantable infusion pumps (ISO 14708-4). In situations where the risk assessment following this standard does not lead to a conclusion, complementary provisions for the assessment of workers exposure for different kinds of AIMDs are given in particular standards for these specific AIMDs (see Figure 1). (...) Figure 1 - Structure of the EN 50527 family of standards

EVS-EN 50527-2-1:2016
Hind 19,05 EUR
Identne EN 50527-2-1:2016
Elektromagnetväljade mõju hindamine aktiivseid implanteeritavaid meditsiiniseadmeid kandvate töötajate korral. Osa 2: Erinõuded südamestimulaatoriga töötajate korral
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they need to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded. NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.

EVS-EN 60601-2-10:2015/A1:2016
Hind 5,62 EUR
Identne IEC 60601-2-10:2012/A1:2016; EN 60601-2-10:2015/A1:2016
Elektrilised meditsiiniseadmed. Osa 2-10: Erinõuded närvi- ja lihasstimulaatorite esmasele ohutusele ja olulistele toimimisnäitajatele
Muudatus standardile EN 60601-2-10:2015
Amendment for EN 60601-2-10:2015


EVS-EN 60601-2-50:2009/A1:2016
Hind 5,62 EUR
Identne IEC 60601-2-50:2009/A1:2016; EN 60601-2-50:2009/A1:2016
Elektrilised meditsiiniseadmed. Osa 2-50: Erinõuded väikelaste füsioteraapiaseadmestiku esmasele ohutusele ja olulistele toimimisnäitajatele
Muudatus standardile EN 60601-2-50:2009
Amendment for EN 60601-2-50:2009


EVS-EN 80601-2-35:2010/A1:2016
Hind 6,47 EUR
Identne IEC 80601-2-35:2009/A1:2016; EN 80601-2-35:2009/A1:2016
Elektrilised meditsiiniseadmed. Osa 2-35: Erinõuded meditsiinilises kasutuses soojendustekkide, -patjade ja –madratsite esmasele ohutusele ja olulistele toimimisnäitajatele
Muudatus standardile EN 80601-2-35:2009
Amendment for EN 80601-2-35:2009


EVS-EN 60601-2-21:2009/A1:2016
Hind 7,38 EUR
Identne IEC 60601-2-21:2009/A1:2016; EN 60601-2-21:2009/A1:2016
Elektrilised meditsiiniseadmed. Osa 2-21: Erinõuded väikelaste kiirgussoojendajate esmasele ohutusele ja olulistele toimimisnäitajatele
Muudatus standardile EN 60601-2-21:2009
Amendment for EN 60601-2-21:2009


EVS-EN 60601-2-20:2009/A1:2016
Hind 8,01 EUR
Identne IEC 60601-2-20:2009/A1:2016; EN 60601-2-20:2009/A1:2016
Elektrilised meditsiiniseadmed. Osa 2-20: Erinõuded imikute transpordi inkubaatorite esmasele ohutusele ja olulistele toimimisnäitajatele
Muudatus standardile EN 60601-2-20:2009
Amendment for EN 60601-2-20:2009


EVS-EN 60601-2-19:2009/A1:2016
Hind 7,38 EUR
Identne IEC 60601-2-19:2009/A1:2016; EN 60601-2-19:2009/A1:2016
Elektrilised meditsiiniseadmed. Osa 2-19: Erinõuded imikuinkubaatorite esmasele ohutusele ja olulistele toimimisnäitajatele
Muudatus standardile EN 60601-2-19:2009
Amendment for EN 60601-2-19:2009


EVS-EN ISO 21535:2009/A1:2016
Hind 4,78 EUR
Identne ISO 21535:2007/Amd 1:2016; EN ISO 21535:2009/A1:2016
Mitteaktiivsed kirurgilised implantaadid. Liigeste asendusimplantaadid. Erinõuded puusaliigese asendusimplantaadile
Muudatus standardile EN ISO 21535:2009
No scope available


EVS-EN ISO 5366:2016
Hind 13,92 EUR
Identne ISO 5366:2016; EN ISO 5366:2016
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support. ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases. Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard. NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.

EVS-EN ISO 15223-1:2016
Hind 15,40 EUR
Identne ISO 15223-1:2016; EN ISO 15223-1:2016
Meditsiiniseadmed. Meditsiiniseadme märgisel, märgistusel ning kaasuvas teabes kasutatavad tingmärgid. Osa 1: Üldnõuded
Selles dokumendis täpsustatakse nõuded meditsiiniseadme märgistamisel kasutatavatele tingmärkidele, mis annavad teavet meditsiiniseadme ohutu ja tõhusa kasutamise kohta. Toodud on ka loend tingmärkidest, mis vastavad selle dokumendi nõuetele. See dokument on kohaldatav tingmärkidele, mida kasutatakse kogu maailmas turustatavate väga erinevate meditsiiniseadmete korral, ja mis seega peavad vastama erinevatele regulatiivsetele nõuetele. Neid tingmärke võib kasutada meditsiiniseadme enda peal, selle pakendi peal või sellega kaasuvas dokumentatsioonis. Selle dokumendi nõuded ei ole kohaldatavad tingmärkidele, mis on spetsifitseeritud muudes standardites.
ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document. ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.


EVS-EN ISO 19054:2006/A1:2016
Hind 4,78 EUR
Identne ISO 19054:2005/Amd 1:2016; EN ISO 19054:2006/A1:2016
Meditsiiniseadmete tugisüsteemid
Muudatus standardile EN ISO 19054:2006
Amendment for EN ISO 19054:2006


EVS-EN 15224:2016
Hind 22,15 EUR
Identne EN 15224:2016
Quality management systems - EN ISO 9001:2015 for healthcare
This European Standard specifies requirements for a quality management system when a healthcare organization: a) needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality characteristics; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility. NOTE 1 Statutory and regulatory requirements can be expressed as legal requirements. Requirements related to material outputs such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of this standard as they are regulated elsewhere. This standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this standard where applicable. This standard aims to adjust and specify the requirements, as well as the “product and service” concept and customer perspectives in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.

EVS-EN ISO 22870:2016
Hind 9,49 EUR
Identne ISO 22870:2016; EN ISO 22870:2016
Patsiendimanused uuringud. Kvaliteedi- ja pädevusnõuded
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.

ISO 10993-6:2016
Hind 128,84 EUR
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. ISO 10993-6:2016 applies to materials that are - solid and non-absorbable, - non-solid, such as porous materials, liquids, gels, pastes, and particulates, and - degradable and/or absorbable, which may be solid or non-solid. The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined. ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.
Asendab ISO 10993-6:2007

ISO 22882:2016
Hind 54,15 EUR
Castors and wheels -- Requirements for castors for hospital beds
ISO 22882:2016 specifies the technical requirements, the appropriate dimensions and the requirements for the testing of swivel castors for hospital beds with a wheel diameter of 100 mm or more and which have a central locking device. Swivel castors may be used with the main principal dimensions.

ISO/TS 20746:2016
Hind 54,15 EUR
Dentistry -- Determination of the strength of dental amalgam by the Hertzian indentation strength (HIT) method
ISO/TS 20746:2016 gives the practical details of the test method for the measurement of the strength of a dental amalgam by the Hertzian indentation strength test (HIT) method. It is applicable to dental amalgam formed from products that are within the scope of ISO 24234 and ISO 20749.

ISO/TR 15499:2016
Hind 82,16 EUR
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993‑1. It does not add to, or otherwise change, the requirements of ISO 10993‑1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
Asendab ISO/TR 15499:2012

IEC 62944:2016
Hind 224,07 EUR
Audio, video and multimedia systems and equipment - Digital television accessibility - Functional specifications
IEC 62944:2016(E) specifies a set of principles and considerations for digital television products in support of older people and persons with disabilities in addition to mainstream users. The effect of following the principles and considerations as set out in this document is to ensure that the widest range of users can access, understand and use digital television products. These principles and considerations cover four main user profiles such as individuals with hearing impairments, individuals with sight impairments, individuals with mobility impairments and individuals with cognitive impairments.

EVS-EN ISO 13485:2016/AC:2016
Hind 0,00 EUR
Identne EN ISO 13485:2016/AC:2016
Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded
Parandus standardile EN ISO 13485:2016
Corrigendum for EN ISO 13485:2016


Asendatud või tühistatud standardid


EVS-EN 23964:1999
Identne ISO 3964:1982; EN 23964:1989+AC1:1990
Hambaraviseadmete käeshoitav komponent. Ühendusdetailide mõõtmed
Standard määrab kindlaks nominaalmõõtmed ja lubatavad tolerantsid liigendühendustele, mida kasutatakse hambaraviseadmete käeshoitava komponendi ja neid käitavate mehhanismide vahel. Standard ei ole rakendatav vanemat tüüpi liugkontaktühendustele. Standard hõlmab ainult mehaaniliselt ühendatud osade aeglase või keskmise kiirusega tüüpe.
Specifies the nominal dimensions and tolerances of the swivel-type coupling used between the dental handpieces and their driving mechanisms. It is not applicable to the older "slip-joint" coupling and restricted to mechanically coupled handpieces of the slow or medium speed types.

Keel: Inglise

EVS-EN ISO 9173-1:2006
Identne ISO 9173-1:2006; EN ISO 9173-1:2006
Hambaväljatõmbamistangid. Osa 1: Kruvi- ja poltliite tüübid
Käesolev standard määrab kindlaks mõõtmed ja kasutusnõuded kruvi- või poltliitega hambaeemaldustangidele (ekstraktsioonitangidele), mis on üldiselt tuntud tangide inglispärase mudelina.
This part of ISO 9173 specifies the general performance requirements for extraction forceps used in dentistry.

Keel: Inglise

EVS-EN ISO 22870:2006
Identne ISO 22870:2006; EN ISO 22870:2006
Patsiendimanused uuringud. Kvaliteedi- ja pädevusnõuded
This International Standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this International Standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care.
Keel: Inglise

EVS-EN ISO 5366-1:2009
Identne ISO 5366-1:2000; EN ISO 5366-1:2009
Anesteesia- ja hingamisseadmed. Trahheostoomiavoolikud. Osa 1: Täiskasvanutele mõeldud voolikud ja ühendused
This part of ISO 5366 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber havinginside diameters of 6,5mm or greater. Such tubes are primarily designed for patients who require anaesthesia, arti-ficial ventilation or other respiratory support, but need not be restricted to these uses.This part of ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomytubes.
Keel: Inglise

EVS-EN ISO 10993-6:2009
Identne ISO 10993-6:2007; EN ISO 10993-6:2009
Meditsiinivahendite bioloogiline hindamine. Osa 6: Katsed implantatsioonijärgsete paiksete toimete hindamiseks
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are: - solid and non-biodegradable; - degradable and/or resorbable; - non-solid, such as porous materials, liquids, pastes and particulates.
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are: - solid and non-biodegradable; - degradable and/or resorbable; - non-solid, such as porous materials, liquids, pastes and particulates.

Keel: Inglise

EVS-EN 50527-1:2010
Identne EN 50527-1:2010
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
The scope of this European Standard is to provide a procedure in order to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace. It specifies how to perform a general risk assessment and to determine whether it is necessary to carry out a detailed risk assessment.
Keel: Inglise

EVS-EN 50527-2-1:2011
Identne EN 50527-2-1:2011
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527-1:2010 for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they have to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks to workers bearing a pacemaker from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded.
Keel: Inglise

EVS-EN ISO 15223-1:2012
Identne ISO 15223-1:2012; EN ISO 15223-1:2012
Meditsiiniseadmed. Sümbolid, mida kasutatakse meditsiinseadme ja/või pakendi märgistuses ning muus kaasuvas teabes. Osa 1: Üldnõuded (ISO 15223-1:2012)
This part of ISO 15223 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of ISO 15223. This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this part of ISO 15223 are not intended to apply to symbols specified in other standards.
Keel: Inglise

EVS-EN 15224:2012
Identne EN 15224:2012
Health care services - Quality management systems - Requirements based on EN ISO 9001:2008
This European standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics ; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility. Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere. This European Standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this European Standard where applicable. This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.
Keel: Inglise
Asendatud EVS-EN 15224:2016

Kavandite arvamusküsitlus


prEN ISO 18618
Identne ISO/DIS 18618.2; prEN ISO 18618
Tähtaeg 3.03.2017
Dentistry - Interoperability of CAD/CAM systems (ISO/DIS 18618:2016)
Interoperability of CAD/CAM systems
Keel: Inglise

prEN ISO 7886-3
Identne ISO/DIS 7886-3; prEN ISO 7886-3
Tähtaeg 3.03.2017
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)
No scope available
Keel: Inglise

prEN ISO 20186-1
Identne ISO/DIS 20186-1; prEN ISO 20186-1
Tähtaeg 3.03.2017
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO/DIS 20186-1:2016)
This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. Blood cellular RNA profiles can change significantly after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA examination and storage. Different dedicated measures need to be taken for stabilising blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this International Standard. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this International Standard. RNA in pathogens present in blood is not covered by this International Standard. NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
Keel: Inglise

prEN ISO 20186-2
Identne ISO/DIS 20186-2; prEN ISO 20186-2
Tähtaeg 3.03.2017
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA correct (ISO/DIS 20186-2:2016)
This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA analysis examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by (e.g., medical laboratories. It is also intended to be used by, laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizsations performing biomedical research, biobanks, and regulatory authorities). Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysisexamination. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures have to be taken for preserving blood cell free circulating DNA, which are not described in this International Standard. Circulating cell free DNA in blood is covered in ISO 20091-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizsing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this International Standard. Pathogen DNA present in blood is not covered by this International Standard. NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
Keel: Inglise

prEN ISO 21533
Identne ISO/DIS 21533; prEN ISO 21533
Tähtaeg 3.03.2017
Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO/DIS 21533:2016)
No scope available
Keel: Inglise

prEN 16777
Identne prEN 16777
Tähtaeg 3.03.2017
Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area - Test method and requirements (phase 2/step 2)
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants that form a homogeneous physically stable preparation when diluted with hard water- or in the case of ready-to-use products - with water. This European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices without mechanical action. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities, and in dental institutions; - in clinics of schools, of kindergartens, and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances on viruses in the conditions in which they are used. NOTE 2 This method corresponds to a phase 2, step 2 test. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Keel: Inglise