Dentistry - Medical devices for dentistry Dental implants. Tandvård - Medicintekniska produkter för tandvård - Dentala implantat

Size: px
Start display at page:

Download "Dentistry - Medical devices for dentistry Dental implants. Tandvård - Medicintekniska produkter för tandvård - Dentala implantat"

Transcription

1 SIS FASTSTÄLLER OCH UTGER SVENSK STANDARD SAMT SÄLJER NATIONELLA, EUROPEISKA OCH INTERNATIONELLA STANDARDPUBLIKATIONER Dentistry - Medical devices for dentistry Dental implants Tandvård - Medicintekniska produkter för tandvård - Dentala implantat The European standard EN 1642:1996 has the status of a Swedish Standard. This document contains the official English version of EN 1642:1996. Swedish Standards corresponding to documents referred to in this Standard are listed in Catalogue of Swedish Standards, issued by SIS. The Catalogue lists, with reference number and year of Swedish approval, International and European Standards approved as Swedish Standards as well as other Swedish Standards. Europastandarden EN 1642:1996 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN 1642:1996. Motsvarigheten och aktualiteten i svensk standard till de publikationer som omnämns i denna standard framgår av Katalog över svensk standard, som ges ut av SIS. I katalogen redovisas internationella och europeiska standarder som fastställts som svenska standarder och övriga gällande svenska standarder.

2

3 English version Dentistry - Medical devices for dentistry - Dental implants Art dentaire Dispositifs médicaux pour I art dentaire Implants dentaires Zahnheilkunde Medizinprodukte für die Zahnheilkunde Dentalimplantate This European Standard was approved by CEN on CEN members are bound to comply with the CEN/CENELEC Internal Regualtions which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

4 Foreword This standard has been prepared by Technical Committee CEN/TC 55 'Dentistry, the secretariat of which is held by DIN. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of the EU Directive(s). For relationship with EU Directive(s), this standard. see informative Annex ZA, which is an integral part of This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 1997, and conflicting national standards shall be withdrawn at the latest by February According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows: Level 1: General requirements for medical devices, Level 2: Level 3: Particular requirements for families of medical devices used in dentistry. Specific requirements for types of medical devices used in dentistry. There are no level 1 standards written exclusively in respect of medical devices used in dentistry. This standard is a level 2 standard and details requirements that apply to dental implants (For surgically implantable dental materials included within the definition of restorative materials see EN 1641). It also indicates that there are additional requirements in the level 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level. In the informative annex A a reference for guidance on the classification of medical devices used in dentstry [3] is given.

5 1 Scope This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN This Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. 2 Normative references This European Standard incorporates by dated or undated reference provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 540 EN 550 EN 552 EN 556 EN 980 pren 1041 EN 1641 EN EN EN EN EN EN EN EN Clinical investigation of medical devices for human subjects Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization Sterilization of medical devices - Validation and routine control of sterilization on by irradiation Sterilization of medical devices - Requirement for medical devices to be labelled 'STERILE Graphical symbols for use in the labelling of medical devices Information supplied by the manufacturer with medical devices Dentistry - Medical devices for dentistry - Materials Dental vocabulary - Part 1: General clinical terms Dental vocabulary - Part 2: Dental materials Data elements and interchange formats - Information interchange - Representation of dates and times Biological evaluation of medical devices - Part 1: Guidance on selection of tests Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - In vitro methods Biological evaluation of medical devices - Part 6: Test for local effects after implantation

6 EN ISO pren ISO 7405 EN ISO EN ISO Dental vocabulary - Part 5: Terms associated with testing Biological evaluation of dental materials Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 3 Definitions For the purposes of this standard the definitions of EN , EN , EN ISO and the following definition apply: dental implant Device designed to be placed surgically within or on the mandibular or maxillary bone to provide resistance to displacement of a dental prosthesis. NOTE: The term dental implant includes transendodontic implants. 4 Requirements 4.1 General Dental implants shall comply with the requirements which are applicable to them bearing in mind the intended purpose of the implant concerned. Conformity with these requirements shall be considered to be met by demonstrating compliance with the following subclauses, as appropriate For dental implants a risk analysis shall be carried out and documented. NOTE: EN 1441 describes a procedure for carrying out and documenting a risk analysis of medical devices. 4.2 Design and properties Dental implants shall be manufactured from materials selected with regard to the properties required for the intended purpose. NOTE: Further information is given in ISO/TR

Tandvård - Periodontalcuretter, scalers och excavatorer - Del 3: Scalers H-typ (ISO :1996)

Tandvård - Periodontalcuretter, scalers och excavatorer - Del 3: Scalers H-typ (ISO :1996) Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers H-type (ISO 13397-3:1996) Tandvård - Periodontalcuretter, scalers och excavatorer - Del 3: Scalers H-typ (ISO 13397-3:1996)

More information

Tandvård Medicintekniska produkter för tandvård Dentala implantat. Dentistry Medical devices for dentistry Dental implants

Tandvård Medicintekniska produkter för tandvård Dentala implantat. Dentistry Medical devices for dentistry Dental implants SVENSK STANDARD SS-EN 1642:2005 Fastställd 2005-04-15 Utgåva 2 Tandvård Medicintekniska produkter för tandvård Dentala implantat Dentistry Medical devices for dentistry Dental implants ICS 11.060.15 Språk:

More information

Kondomer av naturgummilatex för män Natural rubber latex male condoms

Kondomer av naturgummilatex för män Natural rubber latex male condoms Kondomer av naturgummilatex för män Natural rubber latex male condoms Natural rubber latex male condoms The European Standard EN 600:1996 has the status of a Swedish Standard. This document contains the

More information

SVENSK STANDARD SS-EN 1615

SVENSK STANDARD SS-EN 1615 SVENSK STANDARD SS-EN 1615 Fastställd Utgåva Sida 2001-05-04 2 1 (1+14) Copyright SIS. Reproduction in any form without permission is prohibited. Enteral feeding catheters and enteral giving sets for single

More information

http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se Provläsningsexemplar / Preview SVENSK STANDARD SS-EN 980 Fastställd 2003-05-23 Utgåva 2 Grafiska symboler för märkning

More information

SVENSK STANDARD SS-EN ISO 14801:2004. Tandvård Utmattningstest för benförankrade dentala implantat (ISO 14801:2003)

SVENSK STANDARD SS-EN ISO 14801:2004. Tandvård Utmattningstest för benförankrade dentala implantat (ISO 14801:2003) SVENSK STANDARD SS-EN ISO 14801:2004 Fastställd 2004-10-08 Utgåva 1 Tandvård Utmattningstest för benförankrade dentala implantat (ISO 14801:2003) Dentistry Fatigue test for endosseous dental implants (ISO

More information

Tandvård Medicintekniska produkter för tandvård Instrument. Dentistry Medical devices for dentistry Instruments

Tandvård Medicintekniska produkter för tandvård Instrument. Dentistry Medical devices for dentistry Instruments SVENSK STANDARD SS-EN 1639:2005 Fastställd 2005-04-15 Utgåva 2 Tandvård Medicintekniska produkter för tandvård Instrument Dentistry Medical devices for dentistry Instruments ICS 11.060.25 Språk: engelska

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 1640:2004 Stomatoloogia. Meditsiinivahendid stomatoloogias. Aparatuur Dentistry - Medical devices for dentistry - Equipment EESTI STANDARDIKESKUS EESTI STANDARDI EESSÕNA NATIONAL

More information

SVENSK STANDARD SS-EN ISO 22803:2006

SVENSK STANDARD SS-EN ISO 22803:2006 SVENSK STANDARD SS-EN ISO 22803:2006 Fastställd 2006-03-09 Utgåva 1 Tandvård Membran för styrd vävnadsregeneration inom oral och maxillofacial kirurgi Krav på innehåll i teknisk dokumentation (ISO 22803:2004)

More information

Tandvård Arbetsstol (ISO 7493:2006) Dentistry Operator's stool (ISO 7493:2006)

Tandvård Arbetsstol (ISO 7493:2006) Dentistry Operator's stool (ISO 7493:2006) SVENSK STANDARD SS-EN ISO 7493:2006 Fastställd 2006-05-11 Utgåva 2 Tandvård Arbetsstol (ISO 7493:2006) Dentistry Operator's stool (ISO 7493:2006) ICS 11.060.20 Språk: engelska Publicerad: juni 2006 Copyright

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 1641:2004 Stomatoloogia. Meditsiinivahendid stomatoloogias. Materjalid Dentistry - Medical devices for dentistry - Materials EESTI STANDARDIKESKUS EESTI STANDARDI EESSÕNA NATIONAL

More information

Tandvård Konstgjorda tänder för dentala proteser (ISO 22112:2005)

Tandvård Konstgjorda tänder för dentala proteser (ISO 22112:2005) SVENSK STANDARD SS-EN ISO 22112:2006 Fastställd 2006-03-09 Utgåva 1 Tandvård Konstgjorda tänder för dentala proteser (ISO 22112:2005) Dentistry Artificial teeth for dental prostheses (ISO 22112:2005) ICS

More information

Hörselskydd Allmänna fordringar Del 2: Proppar. Hearing protectors General requirements Part 2: Ear-plugs

Hörselskydd Allmänna fordringar Del 2: Proppar. Hearing protectors General requirements Part 2: Ear-plugs SVENSK STANDARD SS-EN 352-2 Fastställd 2003-09-12 Utgåva 2 Hörselskydd Allmänna fordringar Del 2: Proppar Hearing protectors General requirements Part 2: Ear-plugs ICS 13.340.20 Språk: engelska Publicerad:

More information

SVENSK STANDARD SS-EN ISO 21530:2005

SVENSK STANDARD SS-EN ISO 21530:2005 SVENSK STANDARD SS-EN ISO 21530:2005 Fastställd 2005-04-15 Utgåva 1 Tandvård Material för ytor på tandvårdsutrustning Bestämning av beständighet mot kemiska desinfektionsmedel (ISO 21530:2004) Dentistry

More information

SVENSK STANDARD SS-EN ISO

SVENSK STANDARD SS-EN ISO SVENSK STANDARD SS-EN ISO 6402-1 Fastställd 2002-10-11 Utgåva 3 Plast Akrylnitril-styren-akrylat (ASA), akrylnitril-(eten-propen-dien)-styren (AEPDS) och akrylnitril-(klorerad polyeten)-styren (ACS) gjutnings-

More information

SVENSK STANDARD SS-EN

SVENSK STANDARD SS-EN SVENSK STANDARD SS-EN 12006-1 Handläggande organ Fastställd Utgåva Sida Hälso- och sjukvårdsstandardiseringen, HSS 1999-12-22 1 1 (1+50) Copyright SIS. Reproduction in any form without permission is prohibited.

More information

Blodtrycksmätare för indirekt blodtrycksmätning

Blodtrycksmätare för indirekt blodtrycksmätning SVENSK STANDARD SS-EN 1060-4:2004 Fastställd 2004-11-26 Utgåva 1 Blodtrycksmätare för indirekt blodtrycksmätning Del 4: Provningsmetoder för allmän systemnoggrannhet för automatiska blodtrycksmätare Non-invasive

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 17223 March 2018 ICS 03.100.70; 11.040.01 English version Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality

More information

SVENSK STANDARD SS-EN 12821

SVENSK STANDARD SS-EN 12821 SVENSK STANDARD SS-EN 12821 Handläggande organ Fastställd Utgåva Sida Standardiseringsgruppen STG 2000-06-16 1 1 (1+15) Copyright SIS. Reproduction in any form without permission is prohibited. Foodstuffs

More information

Kondomer av naturgummilatex Krav och provningsmetoder (ISO 4074:2002) Natural latex rubber condoms Requirements and test methods (ISO 4074:2002)

Kondomer av naturgummilatex Krav och provningsmetoder (ISO 4074:2002) Natural latex rubber condoms Requirements and test methods (ISO 4074:2002) SVENSK STANDARD SS-EN ISO 4074 Fastställd 2002-06-28 Utgåva 1 Kondomer av naturgummilatex Krav och provningsmetoder (ISO 4074:2002) Natural latex rubber condoms Requirements and test methods (ISO 4074:2002)

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 15854:2005 Dentistry - Casting and baseplate waxes Dentistry - Casting and baseplate waxes EESTI STANDARDIKESKUS EESTI STANDARDI EESSÕNA NATIONAL FOREWORD Käesolev Eesti standard

More information

SVENSK STANDARD SS-EN ISO In vitro-diagnostik Krav på blodglucosmätare avsedda för övervakning av diabetes mellitus (ISO 15197:2003)

SVENSK STANDARD SS-EN ISO In vitro-diagnostik Krav på blodglucosmätare avsedda för övervakning av diabetes mellitus (ISO 15197:2003) SVENSK STANDARD SS-EN ISO 15197 Fastställd 2003-08-01 Utgåva 1 In vitro-diagnostik Krav på blodglucosmätare avsedda för övervakning av diabetes mellitus (ISO 15197:2003) In vitro diagnostic test systems

More information

Foodstuffs Determination of vitamin B1 by HPLC

Foodstuffs Determination of vitamin B1 by HPLC SVENSK STANDARD SS-EN 14122:2004 Fastställd 2004-02-27 Utgåva 1 Livsmedel Vätskekromatografisk bestämning av vitamin B1 Foodstuffs Determination of vitamin B1 by HPLC ICS 67.050 Språk: engelska Publicerad:

More information

http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se Provläsningsexemplar / Preview Teknisk rapport SIS-CEN ISO/TR 25108:2006 Utgåva 1 Oktober 2006 Oförstörande provning

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 16409:2006 Dentistry - Oral hygiene products - Manual interdental brushes Dentistry - Oral hygiene products - Manual interdental brushes EESTI STANDARDIKESKUS EESTI STANDARDI

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 10139-1:2005 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use Dentistry - Soft lining materials for removable dentures - Part 1:

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 12353:2006 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, sporicidal and fungicidal activity Chemical disinfectants

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 13397-2:2005 Hambajuureümbrise küretid, hambakivieemaldamisvahendid ja ekskavaatorid.osa 2: GR-tüüpi hambajuureümbrise küretid Dentistry - Periodontal curettes, dental scalers

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 8:2001 Animal feeding stuffs - Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc - Method using atomic absorption spectrometry

More information

Foodstuffs - Determination of vitamin D by high performance liquid chromatography - Measurement of cholecalciferol (D3) or ergocalciferol (D2)

Foodstuffs - Determination of vitamin D by high performance liquid chromatography - Measurement of cholecalciferol (D3) or ergocalciferol (D2) Irish Standard Foodstuffs - Determination of vitamin D by high performance liquid chromatography - Measurement of cholecalciferol (D3) or ergocalciferol (D2) NSAI 2009 No copying without NSAI permission

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 14885:2006 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics Chemical disinfectants and antiseptics - Application

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 1640:2009 Stomatoloogia. Meditsiinivahendid stomatoloogias. Aparatuur Dentistry - Medical devices for dentistry - Equipment EESTI STANDARDI EESSÕNA Käesolev Eesti standard EVS-EN

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 7405:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry EESTI STANDARDI EESSÕNA NATIONAL FOREWORD Käesolev Eesti standard EVS-EN ISO 7405:2009

More information

Foodstuffs - Detection of irradiated food from which silicate minerals can be isolated - Method by thermoluminescence

Foodstuffs - Detection of irradiated food from which silicate minerals can be isolated - Method by thermoluminescence Foodstuffs - Detection of irradiated food from which silicate minerals can be isolated - Method by thermoluminescence Livsmedel - Analys av bestrålade livsmedel innehållande silikater - Termoluminiscensmetod

More information

http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se Provläsningsexemplar / Preview SVENSK STANDARD SS-EN ISO 6785:2007 Fastställd 2007-06-28 Utgåva 1 Milk and milk

More information

Ergonomi Bedömning av verbal kommunikation (ISO 9921:2003) Ergonomics Assessment of speech communication (ISO 9921:2003)

Ergonomi Bedömning av verbal kommunikation (ISO 9921:2003) Ergonomics Assessment of speech communication (ISO 9921:2003) SVENSK STANDARD SS-EN ISO 9921 Fastställd 2003-10-31 Utgåva 1 Ergonomi Bedömning av verbal kommunikation (ISO 9921:2003) Ergonomics Assessment of speech communication (ISO 9921:2003) ICS 13.180 Språk:

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 10873:2010 Dentistry - Denture adhesives EESTI STANDARDI EESSÕNA Käesolev Eesti standard EVS-EN ISO 10873:2010 sisaldab Euroopa standardi EN ISO 10873:2010 ingliskeelset teksti.

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 16498:2013 Dentistry - Minimal dental implant data set for clinical use (ISO 16498:2013) EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See Eesti standard EVS-EN ISO 16498:2013 sisaldab

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 14663:2006 Foodstuffs - Determination of vitamin B6 (including its glycosylated forms) by HPLC Foodstuffs - Determination of vitamin B6 (including its glycosylated forms) by HPLC

More information

ISO INTERNATIONAL STANDARD. Non-destructive testing Penetrant testing Part 1: General principles

ISO INTERNATIONAL STANDARD. Non-destructive testing Penetrant testing Part 1: General principles INTERNATIONAL STANDARD ISO 3452-1 First edition 2008-09-01 Non-destructive testing Penetrant testing Part 1: General principles Essais non destructifs Examen par ressuage Partie 1: Principes généraux Reference

More information

http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se SVENSK STANDARD SS-EN ISO 23747:2007 Fastställd 2007-07-26 Utgåva 1 Anestesi- och respiratorutrustning Mätare för

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 15136:2006 Materials and articles in contact with foodstuffs - Certain epoxy derivatives subject to limitation - Determination of BADGE, BFDGE and their hydroxy and chlorinated derivatives

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 14486:2005 Water quality - Detection of human enteroviruses by monolayer plaque assay Water quality - Detection of human enteroviruses by monolayer plaque assay EESTI STANDARDIKESKUS

More information

Livsmedel - Analys av bestrålade livsmedel innehållande fett - Gaskromatografisk analys av kolväten

Livsmedel - Analys av bestrålade livsmedel innehållande fett - Gaskromatografisk analys av kolväten Foodstuffs - Detection of irradiated food containing fat - Gas chromatographic analysis of hydrocarbons Livsmedel - Analys av bestrålade livsmedel innehållande fett - Gaskromatografisk analys av kolväten

More information

SVENSK STANDARD SS-EN ISO 7937:2005

SVENSK STANDARD SS-EN ISO 7937:2005 SVENSK STANDARD SS-EN ISO 7937:2005 Fastställd 2005-03-24 Utgåva 1 Microbiology of food and animal feeding stuffs Horizontal method for the enumeration of Clostridium perfringens Colony-count technique

More information

Livsmedel Bestämning av saxitoxin och dc-saxitoxin i musslor HPLC-metod med postkolonn derivatisering

Livsmedel Bestämning av saxitoxin och dc-saxitoxin i musslor HPLC-metod med postkolonn derivatisering SVENSK STANDARD SS-ENV 14194 Fastställd 2002-05-31 Utgåva 1 Livsmedel Bestämning av saxitoxin och dc-saxitoxin i musslor HPLC-metod med postkolonn derivatisering Foodstuffs Determination of saxitoxin and

More information

Hörselskydd Rekommendationer för val, användning, skötsel och underhåll Vägledande

Hörselskydd Rekommendationer för val, användning, skötsel och underhåll Vägledande SVENSK STANDARD SS-EN 458:2005 Fastställd 2005-03-04 Utgåva 2 Hörselskydd Rekommendationer för val, användning, skötsel och underhåll Vägledande dokument Hearing protectors Recommendations for selection,

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 6876:2012 Dentistry - Root canal sealing materials (ISO 6876:2012) EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See Eesti standard EVS-EN ISO 6876:2012 sisaldab Euroopa standardi

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 15197:2003 In vitro laboriklaasil diagnoosimise süsteemid. Nõuded diabeedikute enesetestimise veresuhkru jälgimise süsteemile (ISO 15197:2003) In vitro diagnostic test systems

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 20569:2018 Dentistry - Trephine burs (ISO 20569:2018) EVS-EN ISO 20569:2018 EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See Eesti standard EVS-EN ISO 20569:2018 sisaldab Euroopa

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 14801:2016 Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016) EVS-EN ISO 14801:2016 EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See Eesti

More information

Foodstuffs Determination of vitamin B6 by HPLC

Foodstuffs Determination of vitamin B6 by HPLC SVENSK STANDARD SS-ENV 14164 Fastställd 2002-03-15 Utgåva 1 Livsmedel Vätskekromatografisk bestämning av vitamin B6 Foodstuffs Determination of vitamin B6 by HPLC ICS 07.100.30 Språk: engelska Tryckt i

More information

http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se Provläsningsexemplar / Preview Teknisk specifikation SIS-CEN ISO/TS 17764-2:2006 Utgåva 1 December 2006 Animal

More information

Foodstuffs Determination of vitamin B6 (including its glycosylated forms) by HPLC

Foodstuffs Determination of vitamin B6 (including its glycosylated forms) by HPLC SVENSK STANDARD SS-EN 14663:2005 Fastställd 2005-12-16 Utgåva 1 Foodstuffs Determination of vitamin B6 (including its glycosylated forms) by HPLC ICS 67.050 Språk: engelska Publicerad: februari 2006 Copyright

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 16791 August 2017 ICS 17.180.20 English Version Quantifying irradiance for eye-mediated non-imageforming effects of light in humans Quantification

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 13897:2018 Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018) EVS-EN ISO 13897:2018 EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See Eesti standard EVS-EN ISO 13897:2018

More information

Vibration och stöt Tillståndskontroll och diagnos av maskiner Allmänna riktlinjer för tolkning av data och diagnosteknik (utvärderingsmetoder)

Vibration och stöt Tillståndskontroll och diagnos av maskiner Allmänna riktlinjer för tolkning av data och diagnosteknik (utvärderingsmetoder) SVENSK STANDARD SS-ISO 13379 Fastställd 2003-09-19 Utgåva 1 Vibration och stöt Tillståndskontroll och diagnos av maskiner Allmänna riktlinjer för tolkning av data och diagnosteknik (utvärderingsmetoder)

More information

ISO 7405 INTERNATIONAL STANDARD. Dentistry Evaluation of biocompatibility of medical devices used in dentistry

ISO 7405 INTERNATIONAL STANDARD. Dentistry Evaluation of biocompatibility of medical devices used in dentistry INTERNATIONAL STANDARD ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical devices used in dentistry Art dentaire Évaluation de la biocompatibilité des dispositifs médicaux

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 29843-2 October 2014 ICS 13.080.30 English Version Soil quality - Determination of soil microbial diversity - Part 2:

More information

Teknisk specifikation SIS-CEN/TS :2005

Teknisk specifikation SIS-CEN/TS :2005 Teknisk specifikation SIS-CEN/TS 13130-13:2005 Utgåva 1 April 2005 Material och produkter i kontakt med livsmedel Plaster lydande under begränsningar Del 13: Fastställande av 2,2-bis(4-hydroxifenyl)propan

More information

To provide information on the new standard, a number of EOG members formed a committee to compile information on the following basis:

To provide information on the new standard, a number of EOG members formed a committee to compile information on the following basis: EN 13537 Sleeping Bag Standard Information for Retailers 30.12.2004 Disclaimer This information sheet has been provided by the EOG to help companies assess the implications of the new EN 13537 norm on

More information

Livsmedel Analys av bestrålade livsmedel innehållande silikater Termoluminiscens metod

Livsmedel Analys av bestrålade livsmedel innehållande silikater Termoluminiscens metod SVENSK STANDARD SS-EN 1788 Fastställd 2002-04-26 Utgåva 2 Livsmedel Analys av bestrålade livsmedel innehållande silikater Termoluminiscens metod Foodstuffs Thermoluminescence detection of irradiated food

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 11702:2010 Animal and vegetable fats and oils - Enzymatic determination of total sterols content EESTI STANDARDI EESSÕNA Käesolev Eesti standard EVS-EN ISO 11702:2010 sisaldab

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 15633-3 August 2012 ICS 67.050 English Version Foodstuffs - Detection of food allergens by immunological methods - Part 3:

More information

ISO INTERNATIONAL STANDARD

ISO INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 6360-7 First edition 2006-02-01 Dentistry Number coding system for rotary instruments Part 7: Specific characteristics of mandrels and special instruments Art dentaire Système

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 11701:2010 Vegetable fats and oils - Determination of phospholipids in lecithins by HPLC using a light-scattering detector EESTI STANDARDI EESSÕNA Käesolev Eesti standard EVS-EN

More information

SVENSK STANDARD SS-EN 1657:2005

SVENSK STANDARD SS-EN 1657:2005 SVENSK STANDARD SS-EN 1657:2005 Fastställd 2005-12-28 Utgåva 2 Kemiska desinfektionsmedel och antiseptiska medel Kvantitativt suspensionsprov för utvärdering av den fungicida eller den jästavdödande effekten

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 6874 Third edition 2015-09-01 Dentistry Polymer-based pit and fissure sealants Médecine bucco-dentaire Produits dentaires à base de polymères pour comblement des puits et fissures

More information

ISO INTERNATIONAL STANDARD

ISO INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 22794 First edition 2007-07-15 Corrected version 2009-01-15 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN ISO 7029:2017 Acoustics - Statistical distribution of hearing thresholds related to age and gender (ISO 7029:2017) EVS-EN ISO 7029:2017 EESTI STANDARDI EESSÕNA NATIONAL FOREWORD See

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 13130-13 February 2005 ICS 67.250 English version Materials and articles in contact with foodstuffs - Plastics substances

More information

中国食品安全资源网 Animal feeding stuffs Determination of trypsin inhibitor activity of soya products BS EN ISO 14902:2001

中国食品安全资源网   Animal feeding stuffs Determination of trypsin inhibitor activity of soya products BS EN ISO 14902:2001 BRITISH STANDARD Animal feeding stuffs Determination of trypsin inhibitor activity of soya products The European Standard has the status of a British Standard ICS 65.120 BS EN ISO 14902:2001 NO COPYING

More information

ISO 7885 INTERNATIONAL STANDARD. Dentistry Sterile injection needles for single use

ISO 7885 INTERNATIONAL STANDARD. Dentistry Sterile injection needles for single use Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 7885 Third edition 2010-02-15 Dentistry Sterile injection needles for single use Médecine bucco-dentaire Aiguilles stériles pour injection, non

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 15621:2012 Animal feeding stuffs - Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by

More information

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014 Good Laboratory Practice EU-Serbia screening meeting Brussels, 19 June 2014 Table of contents 1. Background information on the principles of GLP 2. EU legal basis for GLP 3. Role of Member States 4. Role

More information

GENERAL PRINCIPLES ON FLEXIBILITY OF WORDING FOR HEALTH CLAIMS

GENERAL PRINCIPLES ON FLEXIBILITY OF WORDING FOR HEALTH CLAIMS GENERAL PRINCIPLES ON FLEXIBILITY OF WORDING FOR HEALTH CLAIMS These general principles were presented for the first time at an informal meeting in Brussels on 19 June 2012. Experts from 17 Member States

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 17510 First edition 2015-08-01 Medical devices Sleep apnoea breathing therapy Masks and application accessories Dispositifs médicaux Thérapie respiratoire de l apnée du sommeil

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 14708-7 First edition 2013-01-15 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems Implants chirurgicaux Dispositifs

More information

WESTERN EUROPE PREVALENCE AND INCIDENCE OF PERIPHERAL ARTERY DISEASE AND CRITICAL LIMB ISCHEMIA 2017

WESTERN EUROPE PREVALENCE AND INCIDENCE OF PERIPHERAL ARTERY DISEASE AND CRITICAL LIMB ISCHEMIA 2017 WESTERN EUROPE PREVALENCE AND INCIDENCE OF PERIPHERAL ARTERY DISEASE AND CRITICAL LIMB ISCHEMIA 2017 Mary L. Yost 404-520-6652 , LLC 23 Ridge Rd. Beaufort, SC 20097 Copyright Pending 2017 All rights reserved,

More information

This document is a preview generated by EVS

This document is a preview generated by EVS TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN/TS 13130-9 February 2005 ICS 67.250 English version Materials and articles in contact with foodstuffs - Plastics substances

More information

ISO INTERNATIONAL STANDARD. Dentistry Casting and baseplate waxes. Art dentaire Cires pour coulée et pour plaque de base

ISO INTERNATIONAL STANDARD. Dentistry Casting and baseplate waxes. Art dentaire Cires pour coulée et pour plaque de base INTERNATIONAL STANDARD ISO 15854 First edition 2005-07-15 Dentistry Casting and baseplate waxes Art dentaire Cires pour coulée et pour plaque de base Reference number ISO 15854:2005(E) ISO 2005 PDF disclaimer

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 16408 Second edition 2015-08-15 Dentistry Oral care products Oral rinses Médecine bucco-dentaire Produits de soins bucco-dentaire Bains de bouche Reference number ISO 16408:2015(E)

More information

Dentistry Dental amalgam

Dentistry Dental amalgam Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 24234 Second edition 2015-05-01 Dentistry Dental amalgam Médecine bucco-dentaire Amalgame dentaire Reference number ISO 24234:2015(E) ISO 2015

More information

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EUROPEAN COMMISSION Brussels, 17.6.011 COM(011) 35 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 16872:2016 HOMÖOPAATIA LISAKVALIFIKATSIOONIGA ARSTIDE (HLKA-DE) TEENUSED. NÕUDMISED HOMÖOPAATIA LISAKVALIFIKATSIOONIGA ARSTIDE OSUTATUD TERVISHOIUTEENUSTELE Services of Medical Doctors

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 16635-2 First edition 2014-09-15 Dentistry Dental rubber dam instruments Part 2: Clamp forceps Médecine bucco-dentaire Instruments de digue dentaire en caoutchouc Partie 2: Pinces

More information

Dentistry Test methods for machining accuracy of computeraided milling machines

Dentistry Test methods for machining accuracy of computeraided milling machines Provläsningsexemplar / Preview TECHNICAL REPORT ISO/TR 18845 First edition 2017-06 Dentistry Test methods for machining accuracy of computeraided milling machines Médecine bucco-dentaire Méthodes d essai

More information

EESTI STANDARD EVS-EN ISO :2010

EESTI STANDARD EVS-EN ISO :2010 EESTI STANDARD EVS-EN ISO 8253-1:2010 Akustika. Audiomeetrilised katsemeetodid. Osa 1: Puhastooni õhujuhte- ja luujuhteläve audiomeetriline põhimõõtmine Acoustics - Audiometric test methods - Part 1: Basic

More information

SVENSK STANDARD SS-ISO 6472/Amd 1

SVENSK STANDARD SS-ISO 6472/Amd 1 SVENSK STANDARD SS-ISO 6472/Amd 1 Handläggande organ Fastställd Utgåva Sida SVENSK MATERIAL- & MEKANSTANDARD, SMS 1999-07-30 1 1 (1+6) Copyright SIS. Reproduction in any form without permission is prohibited.

More information

ISO/TR TECHNICAL REPORT. Non-destructive testing Guidelines for NDT personnel training organizations

ISO/TR TECHNICAL REPORT. Non-destructive testing Guidelines for NDT personnel training organizations TECHNICAL REPORT ISO/TR 25108 First edition 2006-07-01 Non-destructive testing Guidelines for NDT personnel training organizations Essais non destructifs Lignes directrices pour les organismes de formation

More information

ISO INTERNATIONAL STANDARD. Non-active surgical implants Joint replacement implants Particular requirements

ISO INTERNATIONAL STANDARD. Non-active surgical implants Joint replacement implants Particular requirements INTERNATIONAL STANDARD ISO 21534 Second edition 2007-10-01 Non-active surgical implants Joint replacement implants Particular requirements Implants chirurgicaux non actifs Implants de remplacement d'articulation

More information

Where we stand in EFORT

Where we stand in EFORT Where we stand in EFORT Engaging with the new EU regulatory landscape for medical devices. Challenges & opportunities Brussel, Belgium April 6, 2018 Per Kjaersgaard-Andersen Associate Professor Section

More information

This document is a preview generated by EVS

This document is a preview generated by EVS INTERNATIONAL STANDARD ISO 12891-2 Second edition 2014-09-15 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants Retrait et analyse des implants chirurgicaux Partie

More information

ISO INTERNATIONAL STANDARD. Dentistry Denture adhesives. Médecine bucco-dentaire Adhésifs pour prothèses dentaires. First edition

ISO INTERNATIONAL STANDARD. Dentistry Denture adhesives. Médecine bucco-dentaire Adhésifs pour prothèses dentaires. First edition INTERNATIONAL STANDARD ISO 10873 First edition 2010-09-15 Dentistry Denture adhesives Médecine bucco-dentaire Adhésifs pour prothèses dentaires Reference number ISO 10873:2010(E) ISO 2010 PDF disclaimer

More information

This document is a preview generated by EVS

This document is a preview generated by EVS EESTI STANDARD EVS-EN 16618:2015 Food analysis - Determination of acrylamide in food by liquid chromatography tandem mass spectrometry (LC-ESI-MS/MS) EVS-EN 16618:2015 EESTI STANDARDI EESSÕNA NATIONAL

More information

COMMISSION OF THE EUROPEAN COMMUNITIES

COMMISSION OF THE EUROPEAN COMMUNITIES COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 22.12.2008 COM(2008) 882 final REPORT FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE

More information

ISO INTERNATIONAL STANDARD. Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers

ISO INTERNATIONAL STANDARD. Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers INTERNATIONAL STANDARD ISO 14708-2 Second edition 2012-08-15 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers Implants chirurgicaux Dispositifs médicaux implantables actifs

More information

ISO INTERNATIONAL STANDARD. Dentistry Powered toothbrushes General requirements and test methods

ISO INTERNATIONAL STANDARD. Dentistry Powered toothbrushes General requirements and test methods INTERNATIONAL STANDARD ISO 20127 First edition 2005-03-15 Dentistry Powered toothbrushes General requirements and test methods Art dentaire Brosses à dents électriques Exigences générales et méthodes d'essai

More information