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11.040.01 - Medical equipment in general

NS ICS 11.040.01

Standardsamling

NOK 6 670,80 (excl. VAT)

The collection contains all norwegian standards within ICS 11.040.01: Medical equipment in general

Language: Ukjent

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Produkter (58)

NOK 3 406,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

LanguageEngelskEdition: 1.0 (2012-07-10)

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NOK 3 246,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

LanguageEngelskEdition: 1.0 (2012-07-10)

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NOK 2 885,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

LanguageEngelskEdition: 1.0 (2012-07-10)

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NOK 3 633,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

LanguageEngelskEdition: 1.0 (2012-07-10)

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NOK 3 426,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

LanguageEngelskEdition: 1.0 (2012-07-10)

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NOK 3 065,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

LanguageEngelskEdition: 1.0 (2012-07-10)

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NOK 134,00 (excl. VAT)

Amendment 1 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Languageen/fr en/frEdition: 3.0 (2012-10-25)

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NOK 7 379,00 (excl. VAT)

Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems

Languageen/fr en/frEdition: 2.1 (2012-11-28)

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NOK 2 043,00 (excl. VAT)

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Languageen/fr en/frEdition: 2.0 (2012-11-28)

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NOK 1 776,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

LanguageEngelskEdition: 1.0 (2012-11-29)

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NOK 3 406,00 (excl. VAT)

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Languageen/fr en/frEdition: 1.0 (2013-07-09)

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NOK 3 633,00 (excl. VAT)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Languageen/fr en/frEdition: 4.0 (2014-02-25)

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NOK 1 776,00 (excl. VAT)

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

Languageen/fr en/frEdition: 2.0 (2014-04-10)

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NOK 3 406,00 (excl. VAT)

Medical electrical equipment -- Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

LanguageEngelskEdition: 1 (2004-01-30)

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NOK 0,00 (excl. VAT)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

LanguageEngelskEdition: 1 (2014-06-01)

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NOK 2 043,00 (excl. VAT)

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

LanguageEngelskEdition: 1.0 (2014-06-04)

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NOK 685,00 (excl. VAT)

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

LanguageEngelskEdition: 1 (2014-08-07)

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NOK 1 506,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

LanguageEngelskEdition: 1 (2014-11-20)

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NOK 2 404,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

LanguageEngelskEdition: 1.0 (2014-12-16)

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NOK 2 584,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

LanguageEngelskEdition: 1.0 (2014-12-16)

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NOK 3 211,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

LanguageEngelskEdition: 1 (2015-03-17)

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NOK 780,00 (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: 2015-05 (2015-06-01)

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NOK 1 776,00 (excl. VAT)

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

LanguageEngelskEdition: 1 (2015-06-01)

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NOK 2 404,00 (excl. VAT)

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

LanguageEngelskEdition: 1 (2015-06-01)

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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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ISO 13485:2016

Standard

NOK 2 562,00 (excl. VAT)

Medical devices — Quality management systems — Requirements for regulatory purposes

LanguageEngelskEdition: 3 (2016-02-25)

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ISO 16142-1:2016

Standard

NOK 2 562,00 (excl. VAT)

Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

LanguageEngelskEdition: 1 (2016-03-09)

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NOK 3 246,00 (excl. VAT)

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

LanguageEngelskEdition: 1.0 (2016-05-13)

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NOK 3 633,00 (excl. VAT)

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

LanguageEngelskEdition: 1.0 (2016-04-27)

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NOK 3 246,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

LanguageEngelskEdition: 1.0 (2016-05-19)

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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 7 947,00 (excl. VAT)

Medical device software - Software life cycle processes

LanguageEngelskEdition: 1.1 (2015-06-26)

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NOK 220,00 (excl. VAT)

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

LanguageEngelskEdition: 2009-12 (2017-01-02)

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NOK 267,00 (excl. VAT)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

LanguageEngelskEdition: 1 (2017-04-01)

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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 2 404,00 (excl. VAT)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

LanguageEngelskEdition: 1 (2021-04-01)

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NOK 969,00 (excl. VAT)

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

LanguageEngelskEdition: 1 (2005-06-01)

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CR 14060:2000

Standard

NOK 245,00 (excl. VAT)

Medical device traceability

LanguageEngelskEdition: 1 (2000-11-01)

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NOK 3 406,00 (excl. VAT)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Languageen/fr en/frEdition: 2.0 (2006-10-25)

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NOK 2 404,00 (excl. VAT)

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

LanguageEngelskEdition: 1.0 (1998-01-30)

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NOK 3 406,00 (excl. VAT)

Medical device software - Software life cycle processes

Languageen/fr en/frEdition: 1.0 (2006-05-09)

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NOK 3 406,00 (excl. VAT)

Fundamental aspects of safety standards for medical electrical equipment

Languageen/fr en/frEdition: 2.0 (1994-01-08)

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NOK 1 776,00 (excl. VAT)

Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

LanguageEngelskEdition: 1 (2000-05-18)

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NOK 267,00 (excl. VAT)

Medical electrical equipment -- Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Languageen/fr en/frEdition: 1 (2006-06-01)

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NOK 1 776,00 (excl. VAT)

Medical electrical equipment -- Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

LanguageEngelskEdition: 1 (2008-08-01)

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NOK 3 406,00 (excl. VAT)

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

LanguageEngelskEdition: 1.0 (2009-09-23)

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ISO 15223-2:2010

Standard

NOK 1 506,00 (excl. VAT)

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

LanguageEngelskEdition: 1 (2010-01-15)

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NOK 2 358,00 (excl. VAT)

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

LanguageEngelskEdition: 2011-03 (2011-04-01)

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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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