NS ICS 11.100

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Status: Check Published
Norwegian title: Samlingen inneholder alle norske standarder innenfor ICS 11.100: Laboratoriemedisin
English title: The collection contains all norwegian standards within ICS 11.100: Laboratory medicine
Item type: Standardsamling
Language: Ukjent
Price:

NOK 10 441,50 (excl. VAT)
NOK 13 051,88 (with VAT)

Discounted with:: 50,00%

Full price: NOK 20 883,00 (excl. VAT)
Full price: NOK 26 103,75 (with VAT)

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Innhold av samlingen (78)

NOK 828,00 (excl. VAT)

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

LanguageEngelskEdition: 2020-12 (2021-01-15)

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NOK 1 321,00 (excl. VAT)

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

LanguageEngelskEdition: 2008-10 (2009-02-01)

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NOK 0,00 (excl. VAT)

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

LanguageEngelskEdition: 2009-11 (2010-02-01)

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NOK 673,00 (excl. VAT)

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

LanguageEngelskEdition: 1 (2009-07-01)

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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

LanguageEngelskEdition: 1 (2009-07-01)

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In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

LanguageEngelskEdition: 1 (2009-08-01)

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In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

LanguageEngelskEdition: 1 (2009-08-01)

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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

LanguageEngelskEdition: 1 (2009-09-01)

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NOK 828,00 (excl. VAT)

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

LanguageEngelskEdition: 2009-06 (2009-09-01)

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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

LanguageEngelskEdition: 1 (2010-09-01)

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Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)

LanguageEngelskEdition: 1 (2010-12-01)

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NOK 673,00 (excl. VAT)

Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)

LanguageEngelskEdition: 1 (2011-10-01)

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NOK 481,00 (excl. VAT)

Laboratory glassware - Desiccators (ISO 13130:2011)

LanguageEngelskEdition: 1 (2011-10-01)

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NOK 481,00 (excl. VAT)

Laboratory glassware - Petri dishes (ISO 13132:2011)

LanguageEngelskEdition: 1 (2011-10-01)

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NOK 828,00 (excl. VAT)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

LanguageEngelskEdition: 1 (2012-01-01)

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

LanguageEngelskEdition: 1 (2012-01-01)

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

LanguageEngelskEdition: 1 (2012-01-01)

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

LanguageEngelskEdition: 1 (2012-01-01)

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

LanguageEngelskEdition: 1 (2012-01-01)

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NOK 1 091,00 (excl. VAT)

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)

LanguageEngelskEdition: 1 (2012-03-01)

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In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

LanguageEngelskEdition: 1 (2013-07-01)

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Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

LanguageEngelskEdition: 1 (2014-07-01)

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Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

LanguageEngelskEdition: 1 (2014-07-01)

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NOK 828,00 (excl. VAT)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

LanguageEngelskEdition: 1 (2015-01-01)

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NOK 567,00 (excl. VAT)

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

LanguageEngelskEdition: 1 (2015-09-01)

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NOK 828,00 (excl. VAT)

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

LanguageEngelskEdition: 1 (2015-09-01)

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NOK 828,00 (excl. VAT)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

LanguageEngelskEdition: 1 (2017-03-01)

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NOK 1 091,00 (excl. VAT)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

LanguageEngelskEdition: 1 (2017-08-01)

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NOK 673,00 (excl. VAT)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

LanguageEngelskEdition: 1 (2018-03-01)

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NOK 828,00 (excl. VAT)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

LanguageEngelskEdition: 1 (2018-08-01)

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NOK 673,00 (excl. VAT)

In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

LanguageEngelskEdition: 2021-09 (2021-09-16)

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NS-EN 13532:2002

Standard

NOK 369,00 (excl. VAT)

General requirements for in vitro diagnostic medical devices for self-testing

LanguageEngelskEdition: 1 (2002-07-10)

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NOK 673,00 (excl. VAT)

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

LanguageEngelskEdition: 2021-09 (2021-10-26)

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NS-EN 13612:2002

Standard

NOK 567,00 (excl. VAT)

Performance evaluation of in vitro diagnostic medical devices (Corrigendum AC:2002 incorporated)

LanguageEngelskEdition: 1 (2002-06-10)

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NS-EN 13641:2002

Standard

NOK 369,00 (excl. VAT)

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

LanguageEngelskEdition: 1 (2002-08-12)

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NS-EN 13975:2003

Standard

NOK 567,00 (excl. VAT)

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

LanguageEngelskEdition: 1 (2003-05-09)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA (ISO 4307:2021)

LanguageEngelskEdition: 2021-11 (2021-11-24)

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NOK 673,00 (excl. VAT)

Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)

LanguageEngelskEdition: 2021-10 (2021-11-23)

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NS-EN 14136:2004

Standard

NOK 567,00 (excl. VAT)

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

LanguageEngelskEdition: 1 (2004-08-10)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) — Part 2: Isolated proteins

LanguageEngelskEdition: 2021-12 (2022-01-07)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) — Part 1: Isolated cellular RNA

LanguageEngelskEdition: 2021-12 (2022-01-07)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) — Part 3: Isolated genomic DNA

LanguageEngelskEdition: 2021-12 (2022-01-07)

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NOK 567,00 (excl. VAT)

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1 — Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

LanguageEngelskEdition: 2022-01 (2022-01-21)

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NOK 673,00 (excl. VAT)

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)

LanguageEngelskEdition: 2022-01 (2022-02-01)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Isolated circulating cell free RNA from plasma

LanguageEngelskEdition: 2022-03 (2022-04-30)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — DNA, RNA and proteins

LanguageEngelskEdition: 2022-04 (2022-05-25)

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for urine and other body fluids — Isolated cell free DNA

LanguageEngelskEdition: 2022-06 (2022-08-26)

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NOK 567,00 (excl. VAT)

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

LanguageEngelskEdition: 1 (2003-10-10)

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NOK 673,00 (excl. VAT)

Biological evaluation of medical devices — Part 2: Animal welfare requirements (ISO 10993-2:2022)

LanguageEngelskEdition: 2022-11 (2022-12-02)

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NOK 828,00 (excl. VAT)

In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)

LanguageEngelskEdition: 2022-11 (2022-12-12)

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