Standardiseringsprosjekter og nye standarder

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1 Annonseringsdato: Listenummer: 4/2017 Standardiseringsprosjekter og nye standarder Listenummer: 4/2017 Side: 1 av 122

2 01 Generelt. Terminologi. Standardisering. Dokumentasjon 01 Generelt. Terminologi. Standardisering. Dokumentasjon Standardforslag til høring - europeiske (CEN) EN ISO 7010:2012/prA7 Grafiske symboler - Sikkerhetsfarger og sikkerhetsskilter - Registrerte sikkerhetsskilter - Endringsblad 7 (ISO 7010:2011/Amd 7:2016) Graphical symbols - Safety colours and safety signs - Registered safety signs - Amendment 7 (ISO 7010:2011/Amd 7:2016) Kommentarfrist: pren 1885 Feather and down - Terms and definitions Kommentarfrist: pren Space engineering - Gyros terminology and performance specification Kommentarfrist: pren ISO Societal security - Terminology (ISO/DIS 22300:2017) Kommentarfrist: pren ISO Størrelser og enheter - Del 9: Fysikalsk kjemi og molekylfysikk (ISO/DIS :2017) Quantities and units - Part 9: Physical chemistry and molecular physics (ISO/DIS :2017) Kommentarfrist: pren ISO Størrelser og enheter - Del 11: Karakteriske tall (ISO/DIS :2017) Quantities and units - Part 11: Characteristic numbers (ISO/DIS :2017) Kommentarfrist: Standardforslag til høring - internasjonale (ISO) ISO 7010:2011/DAmd 188 Safety sign E021: Protection shelter Kommentarfrist: ISO 7010:2011/DAmd 189 Safety sign P044: Use of smart glasses prohibited Kommentarfrist: ISO 7010:2011/DAmd 190 Safety sign F007: Fire protection door Kommentarfrist: Listenummer: 4/2017 Side: 2 av 122

3 01 Generelt. Terminologi. Standardisering. Dokumentasjon ISO 7010:2011/DAmd 191 Safety sign M050: Alighting from toboggan to the left Kommentarfrist: ISO 7010:2011/DAmd 192 Safety sign M051: Alighting from toboggan to the right Kommentarfrist: ISO 7010:2011/DAmd 193 Safety sign M052: Keep distance between toboggans Kommentarfrist: ISO 7010:2011/DAmd 195 Safety sign P046: Do not stretch out of toboggan Kommentarfrist: ISO 7010:2011/DAmd 196 Safety sign P047: Do not ram into toboggans Kommentarfrist: ISO 7010:2011/DAmd 197 Safety sign W042: Warning; Arc flash Kommentarfrist: ISO 7010:2011/DAmd 198 Safety sign P043: Not for people in the state of intoxication Kommentarfrist: ISO/DIS Reciprocating internal combustion engines - Vocabulary - Part 1: Terms for engine design and operation Kommentarfrist: ISO/DIS 5593 Rolling bearings -- Vocabulary Kommentarfrist: ISO/DIS Buildings and civil engineering works -- Vocabulary -- Part 1: General terms Kommentarfrist: ISO/DIS Optics and optical instruments - Preparation of drawings for optical elements and systems - Part 14: Wavefront deformation tolerance for systems containing zero-power elements only (Formerly ISO/NP 15000) Kommentarfrist: Listenummer: 4/2017 Side: 3 av 122

4 01 Generelt. Terminologi. Standardisering. Dokumentasjon ISO/DIS Ceramic tile - Definitions, classification, characteristics and marking Kommentarfrist: ISO/DIS Ceramic tiles -- Definitions, classification, characteristics and marking Kommentarfrist: ISO/DIS Graphical symbols -- Safety signs -- Safety way guidance systems (SWGS) Kommentarfrist: ISO/DIS Security and resilience -- Terminology Kommentarfrist: ISO/DIS Quantities and units -- Part 4: Mechanics Kommentarfrist: ISO/DIS Quantities and units -- Part 9: Physical chemistry and molecular physics Kommentarfrist: ISO/DIS Quantities and units -- Part 9: Physical chemistry and molecular physics Kommentarfrist: ISO/DIS Quantities and units -- Part 11: Characteristic numbers Kommentarfrist: ISO/DIS Quantities and units -- Part 11: Characteristic numbers Kommentarfrist: ISO-standarder ISO :2016 Solid mineral fuels -- Vocabulary -- Part 2: Terms relating to sampling, testing and analysis Erstatter A00008:20: ISO 5492:2008/Amd 1:2016 Listenummer: 4/2017 Side: 4 av 122

5 01 Generelt. Terminologi. Standardisering. Dokumentasjon ISO :2017 Earth-moving machinery -- Symbols for operator controls and other displays -- Part 1: Common symbols Erstatter A00008:20:030310,A00008:20: ISO :2017 Earth-moving machinery -- Symbols for operator controls and other displays -- Part 2: Symbols for specific machines, equipment and accessories Erstatter A00008:20:012744,A00008:20:024232,A00008:20: ISO 7112:2017 Machinery for forestry -- Portable brush-cutters and grass-trimmers -- Vocabulary Erstatter A00008:20: Rapporter fra CEN (CR) CEN ISO/TS :2015 Nanotechnologies - Vocabulary - Part 1: Core terms (ISO/TS :2015) CEN ISO/TS :2015 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization (ISO/TS :2013) CEN ISO/TS :2015 Nanotechnologies - Vocabulary - Part 8: Nanomanufacturing processes (ISO/TS :2013) CEN/TS 15398:2016 Resilient, textile and laminate floor coverings - Floor covering standard symbols - Complementary element Resilient, textile and laminate floor coverings - Floor covering standard symbols - Complementary element CEN/TS 15989:2015 Firefighting and rescue service vehicles and equipment - Graphical symbols for control elements and displays and for markings CEN/TS 16981:2016 Photocatalysis - Glossary of terms Fastsatte norske standarder NS-EN 378-1:2016 Kuldeanlegg og varmepumper - Sikkerhets- og miljøkrav - Del 1: Grunnleggende krav, definisjoner, klassifisering og vurderingskriterier Refrigerating systems and heat pumps - Safety and environmental requirements - Part 1: Basic requirements, definitions, classification and selection criteria NS-EN ISO 374-1:2016 Vernehansker mot farlige kjemikalier og mikroorganismer - Del 1: Terminologi og ytelseskrav for kjemiske risikoer (ISO 374-1:2016) Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016) Listenummer: 4/2017 Side: 5 av 122

6 01 Generelt. Terminologi. Standardisering. Dokumentasjon NS-EN ISO 374-5:2016 Vernehansker mot farlige kjemikalier og mikroorganismer - Del 5: Terminologi og ytelseskrav for risikoer for mikroorganismer (ISO 374-5:2016) Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016) NS-EN ISO 7010:2012/A6:2016 Endringsblad A6 - Grafiske symboler - Sikkerhetsfarger og sikkerhetsskilter - Registrerte sikkerhetsskilter (ISO 7010:2011/Amd 6:2014) Amendment A6 - Graphical symbols - Safety colours and safety signs - Registered safety signs (ISO 7010:2011/Amd 6:2014) NS-EN ISO 9999:2016 Hjelpemidler for personer med nedsatt funksjonsevne - Klassifisering og terminologi (ISO 9999:2016) Assistive products for persons with disability - Classification and terminology (ISO 9999:2016) NS-EN ISO :2016 Medisinsk utstyr - Symboler for medisinsk utstyr til bruk på etiketter, som merking og til informasjon - Del 1: Generelle krav (ISO :2016) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO :2016) Tilbaketrukne norske standarder NS-EN 374-1:2003 Vernehansker mot kjemikalier og mikroorganismer - Del 1: Terminologi og funksjonskrav Protective gloves against chemicals and micro-organisms - Part 1: Terminology and performance requirements NS-EN 378-1:2008+A2:2012 Kuldeanlegg og varmepumper - Sikkerhets- og miljøkrav - Del 1: Grunnleggende krav, definisjoner, klassifisering og vurderingskriterier Refrigerating systems and heat pumps - Safety and environmental requirements - Part 1: Basic requirements, definitions, classification and selection criteria Språk: no NS-EN 378-1:2008+A2:2012 Kuldeanlegg og varmepumper - Sikkerhets- og miljøkrav - Del 1: Grunnleggende krav, definisjoner, klassifisering og vurderingskriterier Refrigerating systems and heat pumps - Safety and environmental requirements - Part 1: Basic requirements, definitions, classification and selection criteria NS-EN ISO 9999:2011 Hjelpemidler for personer med redusert funksjonsevne - Klassifisering og terminologi (ISO 9999:2011) Assistive products for persons with disability - Classification and terminology (ISO 9999:2011) Listenummer: 4/2017 Side: 6 av 122

7 01 Generelt. Terminologi. Standardisering. Dokumentasjon NS-EN ISO :2012 Medisinsk utstyr - Symboler for medisinsk utstyr til bruk på etiketter, som merking eller til informasjon - Del 1: Generelle krav (ISO :2012) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO :2012) 03 Sosiologi. Tjenester. Bedriftsorganisasjon og -ledelse. Administrasjon. Transport Standardforslag til høring - europeiske (CEN) pren ISO Electronic fee collection - Evaluation of equipment for conformity to ISO/TS Part 1: Test suite structure and test purposes (ISO/DIS :2017) Kommentarfrist: pren ISO Societal security - Terminology (ISO/DIS 22300:2017) Kommentarfrist: pren ISO Elektronisk avgiftsinnkreving - Definisjon av grensesnitt mellom betalingskort og kjøretøyenhet Electronic fee collection - Interface definition for on-board account using integrated circuit card (ICC) Kommentarfrist: pren ISO Sustainable and traceable cocoa beans - Part 4: Requirements for certification schemes (ISO/DIS :2017) Kommentarfrist: pren ISO/IEC General requirements for the competence of testing and calibration laboratories (ISO/IEC DIS 17025:2016) Kommentarfrist: Standardforslag til høring - internasjonale (ISO) ISO/DIS Control charts -- Part 1: General guidelines Kommentarfrist: ISO/DIS Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) Kommentarfrist: ISO/DIS Steels for the reinforcement of concrete -- Reinforcement couplers for mechanical splices of bars -- Part 3: Conformity assessment scheme Kommentarfrist: Listenummer: 4/2017 Side: 7 av 122

8 03 Sosiologi. Tjenester. Bedriftsorganisasjon og -ledelse. Administrasjon. Transport ISO/DIS Electronic fee collection -- Evaluation of equipment for conformity to ISO/TS Part 1: Test suite structure and test purposes Kommentarfrist: ISO/DIS Project, programme and portfolio management -- Guidance on programme management Kommentarfrist: ISO/DIS Security and resilience -- Terminology Kommentarfrist: ISO/DIS Electronic fee collection -- Interface definition for on-board account using integrated circuit card (ICC) Kommentarfrist: ISO-standarder ISO/TS :2016 Intelligent transport systems - Traffic and travel information (TTI) via transport protocol experts group, generation 2 (TPEG2) -- Part 23: Roads and multimodal routes (TPEG2-RMR) ISO/TS :2017 Intelligent transport systems -- Traffic and travel information (TTI) via transport protocol experts group, generation 2 (TPEG2) -- Part 24: Light encryption (TPEG2-LTE) ISO/TS :2017 Intelligent transport systems -- Traffic and travel information (TTI) via transport protocol experts group, generation 2 (TPEG2) -- Part 25: Electromobility charging infrastructure (TPEG2-EMI) Rapporter fra CEN (CR) CEN ISO/TS 19299:2015 Electronic fee collection - Security framework (ISO/TS 19299:2015) CEN ISO/TR 17424:2015 Intelligent transport systems - Cooperative systems - State of the art of Local Dynamic Maps concepts (ISO/TR 17424:2015) CEN ISO/TS 17425:2016 Intelligent transport systems - Cooperative systems - Data exchange specification for in-vehicle presentation of external road and traffic related data (ISO/TS 17425:2016) CEN ISO/TS 17426:2016 Intelligent transport systems - Cooperative systems - Contextual speeds (ISO/TS 17426:2016) Listenummer: 4/2017 Side: 8 av 122

9 03 Sosiologi. Tjenester. Bedriftsorganisasjon og -ledelse. Administrasjon. Transport CEN ISO/TS 17969:2015 Petroleum, petrochemical and natural gas industries - Guidelines on competency for personnel (ISO/TS 17969:2015) CEN ISO/TS 18750:2015 Intelligent transport systems - Cooperative systems - Definition of a global concept for Local Dynamic Maps (ISO/TS 18750:2015) CEN/TR :2015 Construction products: Assessment of release of dangerous substances - Guidance on the statistical assessment of declared values - Part 1: Principles and rules of application CEN/TR :2015 Construction products: Assessment of release of dangerous substances - Guidance on the statistical assessment of declared values - Part 2: Technical and statistical background CEN/TR 16862:2015 Plastics welding supervisor - Task, responsibilities, knowledge, skills and competence Plastics welding supervisor - Task, responsibilities, knowledge, skills and competence CEN/TR 16886:2016 Guidance on the application of statistical methods for determining the properties of masonry products CEN/TR 16894:2015 Posttjenester - Leveringskvalitet: Ettersending Postal services - Quality of delivery: Reforwarding CEN/TR 16915:2015 Postal Services - Quality of service - Damage to postal items Postal Services - Quality of service - Damage to postal items CEN/TS 14014:2015 Postal services - Hybrid mail - XML definition of encapsulation of letters for automated postal handling CEN/TS 15472:2016 Postal services - Method for measurement of parcel transit time for cross-border parcels within the European Union and EFTA using Tracking and Tracing CEN/TS 16405:2017 Intelligent transport systems - Ecall - Additional data concept specification for heavy goods vehicles CEN/TS :2015 Innovation management - Part 7: Innovation Management Assessment Innovation management - Part 7: Innovation Management Assessment CEN/TS :2015 Electronic fee collection - Secure monitoring for autonomous toll systems - Part 2: Trusted recorder Listenummer: 4/2017 Side: 9 av 122

10 03 Sosiologi. Tjenester. Bedriftsorganisasjon og -ledelse. Administrasjon. Transport CEN/TS 16735:2015 Postal services - Extensible Common Structure and Representation for Postal Rates - EPR CEN/TS 16819:2015 Postal services - Parcel boxes for end use - Technical features CEN/TS 16880:2015 Service excellence - Creating outstanding customer experiences through service excellence CEN/TS 16919:2016 Postal services - Interface and data transfer format for capturing postal automation events IDT-PAE CEN/TS :2015 Security requirements for trustworthy systems managing certificates and time-stamps Fastsatte norske standarder NS-EN :2016 Elektronisk avgiftsinnkreving - Evaluering av samsvar av kjøretøyenhet og veikantutstyr med NS-EN Del 2: Generelt testopplegg Electronic fee collection - Evaluation of on-board and roadside equipment for conformity to EN Part 2: Abstract test suite NS-EN 16872:2016 Tjenester fra leger med tilleggskvalifikasjoner innenfor homeopati - Krav til levering av helsetjenester av leger med tilleggskvalifikasjoner innenfor homeopati Services of Medical Doctors with additional qualification in Homeopathy (MDQH) - Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy NS-EN ISO 17034:2016 Generelle kompetansekrav til produsenter av referansematerialer (ISO 17034:2016) General requirements for the competence of reference material producers (ISO 17034:2016) NS-EN ISO 22870:2016 Pasientnære undersøkelser (point-of-care-testing, POCT) - Krav til kvalitet og kompetanse (ISO 22870:2016) Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) NS-ISO/IEC 27004:2016 Informasjonsteknologi - Sikringsteknikker - Ledelsessystemer for informasjonssikkerhet - Overvåking, måling, analyse og evaluering Information technology - Security techniques - Information security management - Monitoring, measurement, analysis and evaluation Tilbaketrukne norske standarder NS-EN :2011 Elektronisk avgiftsinnkreving - Evaluering av samsvar av kjøretøyenhet og veikantutstyr mot NS-EN Del 2: Generelt prøvingssett Electronic fee collection - Evaluation of on-board and roadside equipment for conformity to EN Part 2: Abstract test suite Listenummer: 4/2017 Side: 10 av 122

11 03 Sosiologi. Tjenester. Bedriftsorganisasjon og -ledelse. Administrasjon. Transport NS-EN ISO 22870:2006 Pasientnære undersøkelser (point-of-care-testing, POCT) - Krav til kvalitet og kompetanse (ISO 22870:2006) Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006) 07 Matematikk. Naturvitenskap Standardforslag til høring - europeiske (CEN) pren ISO Cosmetics - Microbiology - Enumeration of yeast and mould (ISO/FDIS 16212:2017) Kommentarfrist: pren ISO Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO/FDIS 18415:2017) Kommentarfrist: pren ISO Cosmetics - Microbiology - General instructions for microbiological examination (ISO/FDIS 21148:2017) Kommentarfrist: pren ISO Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO/FDIS 21149:2017) Kommentarfrist: Standardforslag til høring - internasjonale (ISO) ISO/DIS Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on product Kommentarfrist: ISO/DIS Microbiology of the food chain -- Horizontal methods for sampling techniques from surfaces using contact plates and swabs Kommentarfrist: CEN Workshop Agreements CWA 17102:2017 Water analysis - Virus sensor system - Monitoring rotavirus, norovirus and hepatitis A virus in various types of water intended for human use Rapporter fra CEN (CR) CEN ISO/TS 18867:2015 Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Detection of pathogenic Yersinia enterocolitica and Yersinia pseudotuberculosis (ISO/DTS 18867:2015) Listenummer: 4/2017 Side: 11 av 122

12 07 Matematikk. Naturvitenskap CEN ISO/TR 19838:2016 Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic Microbiology (ISO/TR 19838:2016) CEN ISO/TS 12025:2015 Nanomaterials - Quantification of nano-object release from powders by generation of aerosols (ISO/TS 12025:2012) CEN ISO/TS 17200:2015 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements (ISO/TS 17200:2013) CEN ISO/TS 17728:2015 Fôr- og næringsmiddelmikrobiologi Prøvetakingsteknikker for mikrobiologisk analyse av mat og fôr prøver (ISO/DTS 17728:2014) Microbiology of the food chain - Sampling techniques for microbiological analysis of food and feed samples (ISO/TS 17728:2015) CEN ISO/TS :2015 Nanotechnologies - Vocabulary - Part 1: Core terms (ISO/TS :2015) CEN ISO/TS :2015 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization (ISO/TS :2013) CEN ISO/TS :2015 Nanotechnologies - Vocabulary - Part 8: Nanomanufacturing processes (ISO/TS :2013) CEN/TR :2015 Geographic information - Spatial data infrastructures - Part 5: Validation and testing CEN/TS :2016 Foodstuffs - Detection of food allergens by molecular biological methods - Part 3: Hazelnut (Corylus avellana) - Qualitative detection of a specific DNA sequence in chocolate by real-time PCR CEN/TS :2016 Matvarer Bestemmelse av allergener i mat ved molekylærbiologisk metode Del 4 Peanøtt (Arachis hypogaea) Kvalitativ bestemmelse av en spesifikk DNA sekvens i sjokolade ved sanntids PCR Foodstuffs - Detection of food allergens by molecular biological methods - Part 4: Peanut (Arachis hypogaea) - Qualitative detection of a specific DNA sequence in chocolate by real-time PCR CEN/TS :2016 Foodstuffs - Detection of food allergens by molecular biological methods - Part 5: Mustard (Sinapis alba) and soya (Glycine max) - Qualitative detection of a specific DNA sequence in cooked sausages by real-time PCR CEN/TS :2015 Ambient air - Monitoring the effects of genetically modified organisms (GMO) - Pollen monitoring - Part 1: Technical pollen sampling using pollen mass filter (PMF) and Sigma-2-sampler CEN/TS :2015 Ambient air - Monitoring the effects of genetically modified organisms (GMO) - Pollen monitoring - Part 2: Biological pollen sampling using bee colonies Listenummer: 4/2017 Side: 12 av 122

13 07 Matematikk. Naturvitenskap CEN/TS 16937:2016 Nanotechnologies - Guidance for the responsible development of nanotechnologies CEN/TS 17010:2016 Nanotechnologies - Guidance on measurands for characterising nano-objects and materials that contain them 11 Helsevesen, Teknikk Standardforslag til høring - europeiske (CEN) EN 12791:2016/prA1:2017 Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2) Kommentarfrist: pren 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) Kommentarfrist: pren ISO Kirurgiske implantater - Metalliske materialer - Del 2: Ulegert titan (ISO/DIS :2017) Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO/DIS :2017) Kommentarfrist: pren ISO Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO/DIS :2017) Kommentarfrist: pren ISO Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO/DIS :2017) Kommentarfrist: pren ISO Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO/DIS 11981:2017) Kommentarfrist: pren ISO Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO/DIS :2016) Kommentarfrist: pren ISO Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA correct (ISO/DIS :2016) Kommentarfrist: Listenummer: 4/2017 Side: 13 av 122

14 11 Helsevesen, Teknikk pren ISO Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO/DIS 21533:2016) Kommentarfrist: pren ISO Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 25424:2017) Kommentarfrist: Standardforslag til høring - internasjonale (ISO) ISO/DIS Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (Revision of second edition (ISO :1993) Kommentarfrist: ISO/DIS 6710 Single-use containers for venous blood specimen collection Kommentarfrist: ISO/DIS Wheelchairs -- Part 2: Determination of dynamic stability of electrically powered wheelchairs Kommentarfrist: ISO/DIS Sterile hypodermic syringes for single use -- Part 3: Auto-disabled syringes for fixed-dose immunization Kommentarfrist: ISO/DIS Gas mixers for medical use -- Stand-alone gas mixers Kommentarfrist: ISO/DIS Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on product Kommentarfrist: ISO/DIS Ophthalmic implants -- Intraocular lenses -- Part 10: Phacic intraocular lenses Kommentarfrist: ISO/DIS Optics and optical instruments - Intraocular lenses - Part 7: Clinical investigations Kommentarfrist: ISO/DIS Optics and optical instruments - contact lenses and contact lens care products - Methods for the determination of the physical compatibility of contact lenses with contact lens care products Kommentarfrist: Listenummer: 4/2017 Side: 14 av 122

15 11 Helsevesen, Teknikk ISO/DIS Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use Kommentarfrist: ISO/DIS Pen systems - Part 2: Plungers and discs for pen-injectors for medical use Kommentarfrist: ISO/DIS Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) Kommentarfrist: ISO/DIS Sterilization of health care products -- Biological and chemical indicators -- Test equipment Kommentarfrist: ISO/DIS Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 1: Isolated cellular RNA Kommentarfrist: ISO/DIS Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA correct Kommentarfrist: ISO/DIS Prosthetics and orthotics -- Soft orthoses -- Uses, functions, classification and description Kommentarfrist: ISO/DIS Prosthetics and orthotics -- Foot orthotics -- Uses, functions classification and description Kommentarfrist: ISO/DIS Prosthetics and orthotics -- Terms relating to the treatment and rehabilitation of persons having a lower limb amputation Kommentarfrist: ISO/DIS Dentistry -- Reusable dental syringes designed for intraligamentary injections Kommentarfrist: ISO/DIS Dentistry -- Reusable cartridge syringes intended for intraligamentary injections Kommentarfrist: Listenummer: 4/2017 Side: 15 av 122

16 11 Helsevesen, Teknikk ISO/DIS Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices Kommentarfrist: ISO/DIS Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices Kommentarfrist: ISO/DIS Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Kommentarfrist: ISO/DIS Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Kommentarfrist: ISO-standarder ISO :2017 Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses Erstatter A00008:20:035886,A00008:20: ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process Erstatter A00008:20: ISO/TS 20746:2016 Dentistry -- Determination of the strength of dental amalgam by the Hertzian indentation strength (HIT) method Rapporter fra CEN (CR) CEN/TR 16824:2015 Early care services for babies born with cleft lip and/or palate CEN/TS 14237:2015 Textiles for healthcare and social services facilities CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins Listenummer: 4/2017 Side: 16 av 122

17 11 Helsevesen, Teknikk CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA CEN/TS :2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma CEN/TS 16850:2015 Societal and Citizen Security - Guidance for managing security in healthcare facilities CEN/TS 16945:2016 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma Fastsatte norske standarder NS-EN 16872:2016 Tjenester fra leger med tilleggskvalifikasjoner innenfor homeopati - Krav til levering av helsetjenester av leger med tilleggskvalifikasjoner innenfor homeopati Services of Medical Doctors with additional qualification in Homeopathy (MDQH) - Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy NS-EN ISO 3964:2016 Tannpleie - Tilknytningsmål for håndstykker for dental bruk (ISO 3964:2016) Dentistry - Coupling dimensions for handpiece connectors (ISO 3964:2016) NS-EN ISO 5366:2016 Anestesi- og respirasjonsutstyr - Trakeostomituber og forbindelser (ISO 5366:2016) Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016) Listenummer: 4/2017 Side: 17 av 122

18 11 Helsevesen, Teknikk NS-EN ISO :2016 Kirurgiske implantater - Metalliske materialer - Del 3: Plastisk bearbeidet titanlegering med 6 % aluminium og 4 % vanadium (ISO :2016) Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO :2016) NS-EN ISO :2016 Kirurgiske instrumenter - Materialer - Del 1: Metaller (ISO :2016) Surgical instruments - Materials - Part 1: Metals (ISO :2016) NS-EN ISO :2016 Infusjonsutstyr til medisinsk bruk - Del 13: Graderte strømningsregulatorer for engangsbruk med kontakt med væske (ISO :2016) Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO :2016) NS-EN ISO :2016 Elastomere deler for parenterale løsninger og for utstyr til farmasøytisk bruk - Del 5: Funksjonskrav og prøving (ISO :2016) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO :2016) NS-EN ISO :2016 Tannpleie - Ekstraksjonsstenger - Del 1: Generelle krav (ISO :2016) Dentistry - Extraction forceps - Part 1: General requirements (ISO :2016) NS-EN ISO 9999:2016 Hjelpemidler for personer med nedsatt funksjonsevne - Klassifisering og terminologi (ISO 9999:2016) Assistive products for persons with disability - Classification and terminology (ISO 9999:2016) NS-EN ISO 10938:2016 Oftalmisk opptikk - Synstavler for synsprøver - Trykte, projiserte og elektroniske (ISO 10938:2016) Ophthalmic optics - Chart displays for visual acuity measurement - Printed, projected and electronic (ISO 10938:2016) NS-EN ISO 11381:2016 Oftalmisk optikk - Brilleinnfatninger - Skruegjenger (ISO 11381:2016) Ophthalmic optics - Spectacle frames - Screw threads (ISO 11381:2016) NS-EN ISO 14801:2016 Tannpleie - Implantater - Dynamisk belastningsprøving for endostale implantater (ISO 14801:2016) Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016) NS-EN ISO :2016 Medisinsk utstyr - Symboler for medisinsk utstyr til bruk på etiketter, som merking og til informasjon - Del 1: Generelle krav (ISO :2016) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO :2016) NS-EN ISO 17509:2016 Tannpleie - Momentnøkkel til håndstykker benyttet for implantering (ISO 17509:2016) Dentistry - Torque transmitter for handpieces (ISO 17509:2016) Listenummer: 4/2017 Side: 18 av 122

19 11 Helsevesen, Teknikk NS-EN ISO 22870:2016 Pasientnære undersøkelser (point-of-care-testing, POCT) - Krav til kvalitet og kompetanse (ISO 22870:2016) Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) Tilbaketrukne norske standarder NS-EN ISO :2009 Anestesi- og respirasjonsutstyr - Trakeostomituber - Del 1: Tuber og forbindelser for voksne (ISO :2000) Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO :2000) NS-EN ISO :2012 Kirurgiske implantater - Metalliske materialer - Del 3: Plastisk bearbeidet titanlegering med 6 % aluminium og 4 % vanadium (ISO :1996) Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO :1996) NS-EN ISO :2000 Tannpleie - Kirurgiske instrumenter - Metalliske materialer - Del 1: Rustfritt stål (ISO :1991, innbefattet endringsblad A1:1999) Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO :1991, including Amendment A1:1999) NS-EN ISO :2014 Elastomere deler for parenterale løsninger og for utstyr til farmasøytisk bruk - Del 5: Funksjonskrav og prøving (ISO :2005) Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO :2005) NS-EN ISO :2006 Tannpleie - Ekstraksjonsstenger - Del 1: Generelle krav og prøvingsmetoder (ISO :2006) Dentistry - Extraction forceps - Part 1: General requirements and test methods (ISO :2006) NS-EN ISO 9999:2011 Hjelpemidler for personer med redusert funksjonsevne - Klassifisering og terminologi (ISO 9999:2011) Assistive products for persons with disability - Classification and terminology (ISO 9999:2011) NS-EN ISO 10938:1998 Ophthalmic instruments - Chart projectors (ISO 10938:1998) NS-EN ISO 11381:1996 Optikk og optiske instrumenter - Øyeoptikk - Skrugjenger (gjengesnitt) (ISO 11381:1994) Optics and optical instruments - Ophthalmic optics - Screw threads (ISO 11381:1994) Listenummer: 4/2017 Side: 19 av 122

20 11 Helsevesen, Teknikk NS-EN ISO 14801:2007 Tannpleie - Implantater - Utmattelsesprøving for endostale implantater (ISO 14801:2007) Dentistry - Implants - Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) NS-EN ISO :2012 Medisinsk utstyr - Symboler for medisinsk utstyr til bruk på etiketter, som merking eller til informasjon - Del 1: Generelle krav (ISO :2012) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO :2012) NS-EN ISO 22870:2006 Pasientnære undersøkelser (point-of-care-testing, POCT) - Krav til kvalitet og kompetanse (ISO 22870:2006) Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006) NS-ISO 3964:1982 Tannpleie - Håndstykker for dentalt bruk - Tilknytningsmål (= EN 23964) (ISO 3964:1982) Dentistry - Dental handpieces - Coupling dimensions (= EN 23964) (ISO 3964:1982) 13 Miljøvern. Helsevern. Sikkerhet Standardforslag til høring - europeiske (CEN) EN 353-1:2014/prA1:2017 Personal fall protection equipment - Guided type fall arresters including an anchor line - Part 1: Guided type fall arresters including a rigid anchor line Kommentarfrist: EN ISO 14044:2006/prA1 Environmental management - Life cycle assessment - Requirements and guidelines (ISO 14044:2006/DAM 1:2016) Kommentarfrist: pren Secure storage units - Requirements, classification and methods of test for resistance to burglary - Part 1: Safes, ATM safes, strongroom doors and strongrooms Kommentarfrist: pren Respiratory protective devices - Powered filtering devices incorporating a loose fitting respiratory interface - Requirements, testing, marking Kommentarfrist: pren Respiratory protective devices - Power filtering devices incorporating full face masks, half masks or quarter masks - Requirements, testing, marking Kommentarfrist: Listenummer: 4/2017 Side: 20 av 122

21 13 Miljøvern. Helsevern. Sikkerhet pren Beskyttelsesutstyr for å hindre forurensning av drikkevann ved tilbakestrømming - Luftgap med ikke-sirkulært overløp (uhindret) - Gruppe A - Type B Devices to prevent pollution by backflow of potable water - Air gap with non-circular overflow (unrestricted) - Family A - Type B Kommentarfrist: pren Protective clothing - Protective jackets, body and shoulder protectors for equestrian use, for horse riders and those working with horses, and for horse drivers - Requirements and test methods Kommentarfrist: pren Hearing protectors - Testing - Part 3: Supplementary acoustic test method Kommentarfrist: pren Cold applied joint sealants - Test methods - Part 7: Determination of the resistance to flame Kommentarfrist: pren Utstyr for eksplosjonsmotstand Explosion resistant equipment Kommentarfrist: pren Respiratory protective devices - Compressed air line breathing apparatus with demand valve - Part 1: Devices with a full face mask- Requirements, testing and marking Kommentarfrist: pren Respiratory protective devices - Continuous flow compressed air line breathing devices - Requirements, testing and marking Kommentarfrist: pren Utvidet anvendelse av resultater fra brannmotstandsprøving - Ikke-bærende vegger - Del 4: Glasskonstruksjoner Extended application of results from fire resistance tests - Non-loadbearing walls - Part 4: Glazed constructions Kommentarfrist: pren Utvidet anvendelse av resultater fra brannmotstandsprøving - Ikke-bærende himlinger - Del: 7 Sandwichkonstruksjoner av metall Extended application of results from fire resistance tests - Non-loadbearing ceilings - Part 7: Metal sandwich panel construction Kommentarfrist: pren Vannundersøkelse Generelle krav og prosedyrer for ytelsesprøving av vannovervåkingsutstyr Måleinstrumenter Water quality - General requirements and performance test procedures for water monitoring equipment - Measuring devices Kommentarfrist: Listenummer: 4/2017 Side: 21 av 122

22 13 Miljøvern. Helsevern. Sikkerhet pren Determination of burning behaviour of dust layers Kommentarfrist: pren Railway applications - Fire protection in railway vehicles - Toxicity test of materials and components Kommentarfrist: pren ISO Akustikk - Referanseverdier til kalibrering av audiometre - Del 1: Ekvivalente referanselydtrykknivåer for rentoner og supra-aurale øretelefoner Acoustics - Reference zero for the calibration of audiometric equipment - Part 1: Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones (ISO/DIS 389-1:2016) Kommentarfrist: pren ISO Safety devices for protection against excessive pressure - Part 2: Bursting disc safety devices (ISO/DIS :2017) Kommentarfrist: pren ISO Water quality - Determination of free chlorine and total chlorine - Part 2: Colorimetric method using N,N-diethyl-1,4- phenylenediamine, for routine control purposes Kommentarfrist: pren ISO Ergonomi for samhandling mellom menneske og system - Del 11: Brukskvalitet. Definisjoner og begreper (ISO/DIS :2015) Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts (ISO/DIS :2016) Kommentarfrist: pren ISO Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts (ISO/DIS :2016) Kommentarfrist: pren ISO Vernetøy for brukere av håndholdte kjedesager - Del 1: Utstyr for prøving av motstand mot gjennomskjæring med kjedesag Protective clothing for users of hand-held chain-saws - Part 1: Test rig for testing resistance to cutting by a chain-saw (ISO/DIS :2016) Kommentarfrist: pren ISO Vernetøy for brukere av håndholdte kjedesager - Del 2: Ytelseskrav og prøvingsmetoder for benvern Protective clothing for users of hand-held chainsaws - Part 2: Performance requirements and test methods for leg protectors (ISO/DIS :2016) Kommentarfrist: pren ISO Vernetøy for brukere av håndholdte kjedesager - Del 3: Prøvingsmetoder for fottøy Protective clothing for users of hand-held chain-saws - Part 3: Test methods for footwear (ISO/DIS :2016) Kommentarfrist: Listenummer: 4/2017 Side: 22 av 122

23 13 Miljøvern. Helsevern. Sikkerhet pren ISO Vernetøy for brukere av håndholdte kjedesager - Del 4: Prøvingsmetoder og ytelseskrav for vernehansker Protective clothing for users of hand-held chain-saws - Part 4: Test methods and performance requirements for protective gloves (ISO/DIS :2016) Kommentarfrist: pren ISO Vernetøy for brukere av håndholdte kjedesager - Del 5: Prøvingsmetoder og ytelseskrav for beskyttelsesgamasjer Protective clothing for users of hand-held chain-saws - Part 5: Test methods and performance requirements for protective gaiters (ISO/DIS :2016) Kommentarfrist: pren ISO Vernetøy for brukere av håndholdte kjedesager - Del 6 Prøvingsmetoder og ytelsesskrav for overkroppsvern Protective clothing for users of hand-held chain-saws - Part 6: Test methods and performance requirements for upper body protectors (ISO/DIS :2016) Kommentarfrist: pren ISO Safety of machinery - Laser processing machines - Part 1: General safety requirements (ISO/DIS :2016) Kommentarfrist: pren ISO Safety of machinery - Laser processing machines - Part 2: Safety requirements for hand-held laser processing devices (ISO/DIS :2016) Kommentarfrist: pren ISO Tekstiler - Metoder for husholdningsvask av tekstiler forut for prøving av flambarhet (ISO/DIS 12138:2017) Textiles - Domestic laundering procedures for textile fabrics prior to flammability testing (ISO/DIS 12138:2017) Kommentarfrist: pren ISO Renrom og tilhørende kontrollerte omgivelser - Del 3: Prøvingsmetoder Cleanrooms and associated controlled environments - Part 3: Test methods (ISO/DIS :2016) Kommentarfrist: pren ISO Geotechnical investigation and testing - Laboratory testing of soil - Part 12: Determination of liquid and plastic tests (ISO/DIS :2016) Kommentarfrist: pren ISO Protective clothing for firefighters - Physiological impact - Part 1: Measurement of coupled heat and moisture transfer with the sweating TORSO (ISO/DIS :2017) Kommentarfrist: Listenummer: 4/2017 Side: 23 av 122

24 13 Miljøvern. Helsevern. Sikkerhet pren ISO Protective clothing for firefighters - Physiological impact - Part 1: Measurement of coupled heat and moisture transfer with the sweating TORSO (ISO/DIS :2017) Kommentarfrist: pren ISO Protective clothing for fire-fighters - Physiological impact - Part 2: Determination of physiological heat load caused by protective clothing worn by firefighters (ISO/DIS :2017) Kommentarfrist: pren ISO Protective clothing for fire-fighters - Physiological impact - Part 2: Determination of physiological heat load caused by protective clothing worn by firefighters (ISO/DIS :2017) Kommentarfrist: pren ISO Soil quality - Determination of selected organotin compounds - Gas-chromatographic method (ISO/FDIS 23161:2016) Kommentarfrist: pren ISO The human-centred organization - Rationale and general principles (ISO 27500:2016) Kommentarfrist: pren ISO Kraftdrevet håndverktøy - Metoder for måling av vibrasjonsemisjon - Del 13: Festeverktøy Hand-held portable power tools - Test methods for evaluation of vibration emission - Part 13: Fastener driving tools (ISO/DIS :2017) Kommentarfrist: Standardforslag til høring - internasjonale (ISO) ISO 14044:2006/DAmd 1 Kommentarfrist: ISO/DIS Akustikk - Referanseverdier til kalibrering av audiometre - Del 1: Ekvivalente referanselydtrykknivåer for rentoner og supra-aurale øretelefoner Acoustics -- Reference zero for the calibration of audiometric equipment -- Part 1: Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones Kommentarfrist: ISO/DIS Safety devices for protection against excessive pressure - Part 2: Bursting disc safety devices (Revision of ISO 4126:1981) Kommentarfrist: ISO/DIS Akustikk Hørselsvern Del 6: Bestemmelse av lyddemping av øreklokker med aktiv støyreduksjon Acoustics -- Hearing protectors -- Part 6: Determination of sound attenuation of active noise reduction earmuffs Kommentarfrist: Listenummer: 4/2017 Side: 24 av 122

25 13 Miljøvern. Helsevern. Sikkerhet ISO/DIS Vannundersøkelse Bestemmelse av fritt klor og totalklor Kolorimetrisk metode med N,N-dietyl-1,4-fenylendiamin for rutinekontroll Water quality -- Determination of free chlorine and total chlorine -- Part 2: Colorimetric method using N,N-diethyl-1,4- phenylenediamine, for routine control purposes Kommentarfrist: ISO/DIS Ergonomics of human-system interaction -- Part 11: Usability: Definitions and concepts Kommentarfrist: ISO/DIS Vernetøy for brukere av håndholdte kjedesager - Del 1: Utstyr for prøving av motstand mot gjennomskjæring med kjedesag Protective clothing for users of hand-held chain-saws -- Part 1: Test rig for testing resistance to cutting by a chain-saw Kommentarfrist: ISO/DIS Vernetøy for brukere av håndholdte kjedesager - Del 2: Ytelseskrav og prøvingsmetoder for benvern Protective clothing for users of hand-held chainsaws -- Part 2: Performance requirements and test methods for leg protectors Kommentarfrist: ISO/DIS Vernetøy for brukere av håndholdte kjedesager - Del 3: Prøvingsmetoder for fottøy Protective clothing for users of hand-held chain-saws -- Part 3: Test methods for footwear Kommentarfrist: ISO/DIS Vernetøy for brukere av håndholdte kjedesager - Del 4: Prøvingsmetoder og ytelseskrav for vernehansker Protective clothing for users of hand-held chain-saws -- Part 4: Test methods and performance requirements for protective gloves Kommentarfrist: ISO/DIS Vernetøy for brukere av håndholdte kjedesager - Del 5: Prøvingsmetoder og ytelseskrav for beskyttelssgamasjer Protective clothing for users of hand-held chain-saws -- Part 5: Test methods and performance requirements for protective gaiters Kommentarfrist: ISO/DIS Protective clothing for users of hand-held chain-saws -- Part 6: Test methods and performance requirements for upper body protectors Kommentarfrist: ISO/DIS Vernetøy for brukere av håndholdte kjedesager - Del 6 Prøvingsmetoder og ytelsesskrav for overkroppsvern Protective clothing for users of hand-held chain-saws -- Part 6: Test methods and performance requirements for upper body protectors Kommentarfrist: Listenummer: 4/2017 Side: 25 av 122

26 13 Miljøvern. Helsevern. Sikkerhet ISO/DIS Protective clothing for users of hand-held chain-saws - Part 2: Test methods and performance requirements for leg protectors Kommentarfrist: ISO/DIS Protective clothing for users of hand-held chain-saws - Part 3: Test methods for footwear Kommentarfrist: ISO/DIS Protective clothing for users of hand-held chain-saws -- Part 4: Test methods and performance requirements for protective gloves Kommentarfrist: ISO/DIS Protective clothing for users of hand-held chain-saws - Part 5: Test methods and performance requirements for protective gaiters Kommentarfrist: ISO/DIS Safety of machinery -- Laser processing machines -- Part 2: Safety requirements for hand-held laser processing devices Kommentarfrist: ISO/DIS Textiles - Domestic laundering procedure for textile fabrics prior to flammability testing Kommentarfrist: ISO/DIS Environmental labels and declarations -- Principles, requirements and guidelines for communication of footprint information Kommentarfrist: ISO/DIS Radiological protection -- Criteria and performance limits for the periodic evaluation of dosimetry services Kommentarfrist: ISO/DIS Renrom og tilhørende kontrollerte omgivelser - Del 3: Metrologi og testmetoder (ISO/DIS :2002) Cleanrooms and associated controlled environments -- Part 3: Metrology and test methods Kommentarfrist: ISO/DIS Cleanrooms and associated controlled environments -- Part 3: Test methods Kommentarfrist: ISO/DIS Cleanrooms and associated controlled environments -- Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration Kommentarfrist: Listenummer: 4/2017 Side: 26 av 122