11.040.01 : Medical equipment in general

UNE-EN 60601-1:2008 CORR:2010

UNE-EN 60601-1:2008 CORR:2010

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Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

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UNE-EN 60601-1-8:2008 CORR:2010

UNE-EN 60601-1-8:2008 CORR:2010

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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

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UNE-EN 80601-2-59:2010

UNE-EN 80601-2-59:2010

Superseded Historical

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

€89.00

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UNE-EN 60601-1-6:2010

UNE-EN 60601-1-6:2010

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Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

€77.00

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UNE-EN 1041:2009+A1:2014

UNE-EN 1041:2009+A1:2014

Superseded Historical

Information supplied by the manufacturer of medical devices

€74.00

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UNE-EN 60601-1-8:2008/A1:2013/AC:2014

UNE-EN 60601-1-8:2008/A1:2013/AC:2014

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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

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UNE-EN ISO 14971:2020

UNE-EN ISO 14971:2020

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

€98.00

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UNE-EN 61847:2000

UNE-EN 61847:2000

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ULTRASONICS- SURGICAL SYSTEMS - MEASUREMENT AND DECLARATION OF THE BASIC OUTPUT CHARACTERISTICS

€81.00

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UNE-EN ISO 9997:2000 (R2008)

UNE-EN ISO 9997:2000 (R2008)

Superseded Historical

DENTAL CARTRIDGE SYRINGES (ISO 9997:1999)

€58.00

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UNE-ENV 13004:2000

UNE-ENV 13004:2000

Withdrawn Most Recent

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

€40.00

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UNE-EN 61847:2003 ERRATUM

UNE-EN 61847:2003 ERRATUM

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

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UNE-EN 80001-1:2012

UNE-EN 80001-1:2012

Superseded Historical

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

€93.00

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UNE-EN ISO 14971:2012

UNE-EN ISO 14971:2012

Superseded Historical

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

€134.00

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UNE-EN ISO 13485:2018/A11:2022

UNE-EN ISO 13485:2018/A11:2022

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

€76.00

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UNE-EN 62353:2015

UNE-EN 62353:2015

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Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

€115.00

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