NS ICS 11.040.01

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Status: Check Published
Norwegian title: Samlingen inneholder alle norske standarder innenfor ICS 11.040.01: Medisinsk utstyr generelt
English title: The collection contains all norwegian standards within ICS 11.040.01: Medical equipment in general
Item type: Standardsamling
Language: Ukjent
Price:

NOK 6 670,80 (excl. VAT)
NOK 8 338,50 (with VAT)

Discounted with:: 10,00%

Full price: NOK 7 412,00 (excl. VAT)
Full price: NOK 9 265,00 (with VAT)

Adopted:

 

Innhold av samlingen (19)

NS-EN 15986:2011

Standard

NOK 530,00 (excl. VAT)

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

LanguageEngelskEdition: 1 (2011-06-01)

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NOK 775,00 (excl. VAT)

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

LanguageEngelskEdition: 1 (2015-11-01)

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NOK 893,00 (excl. VAT)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

LanguageEngelskEdition: 1 (2016-06-01)

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NOK 630,00 (excl. VAT)

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

LanguageEngelskEdition: 1 (2016-07-01)

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NOK 969,00 (excl. VAT)

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

LanguageEngelskEdition: 1 (2018-01-01)

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NOK 969,00 (excl. VAT)

Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

LanguageEngelskEdition: 1 (2018-03-21)

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NOK 775,00 (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 969,00 (excl. VAT)

Medical devices — Information to be supplied by the manufacturer (ISO 20417:2021)

LanguageEngelskEdition: 2021-05 (2021-06-24)

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NOK 893,00 (excl. VAT)

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (ISO 15223-1:2021)

LanguageEngelskEdition: 2021-09 (2022-05-05)

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NOK 630,00 (excl. VAT)

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016)

LanguageEngelskEdition: 2021-09 (2022-05-05)

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NOK 450,00 (excl. VAT)

Medical devices — Application of risk management to medical devices (ISO 14971:2019)

LanguageEngelskEdition: 2021-12 (2021-12-16)

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NOK 775,00 (excl. VAT)

Medical supply units (ISO 11197:2019)

LanguageEngelskEdition: 1 (2020-02-01)

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NOK 775,00 (excl. VAT)

Medical devices — Application of risk management to medical devices (ISO 14971:2019)

LanguageEngelskEdition: 2019-12 (2020-03-01)

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NOK 630,00 (excl. VAT)

Privacy of monitoring technology — Guidelines for introducing ambient and wearable monitoring technologies balancing privacy protection against the need for oversight and care

LanguageEngelskEdition: 2020-02 (2020-02-12)

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NOK 630,00 (excl. VAT)

Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances

LanguageEngelskEdition: 2020-03 (2020-05-01)

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NOK 775,00 (excl. VAT)

Medical vehicles and their equipment — Air ambulances — Part 2: Operational and technical requirements for air ambulances

LanguageEngelskEdition: 2015-03 (2020-05-01)

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NOK 893,00 (excl. VAT)

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016)

LanguageEngelskEdition: 2016-03 (2018-06-01)

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NOK 1 235,00 (excl. VAT)

Medical devices — Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

LanguageEngelskEdition: 2020-07 (2020-08-12)

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NOK 775,00 (excl. VAT)

Medical devices — Post-market surveillance for manufacturers (ISO/TR 20416:2020)

LanguageEngelskEdition: 2020-08 (2020-09-07)

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