11.040.01 : Medical equipment in general

UNE-EN 60601-1-8:2008

UNE-EN 60601-1-8:2008

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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 60601-1:2008 ERRATUM:2008

UNE-EN 60601-1:2008 ERRATUM:2008

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

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UNE-EN 60601-1-9:2008

UNE-EN 60601-1-9:2008

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Medical electrical equipment- Part 1-9: General requirements for basic safety and essential performance- Collateral Standard: Requirements for environmentally conscious design

€83.00

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UNE-EN 60601-1-10:2008

UNE-EN 60601-1-10:2008

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Medical electrical equipment- Part 1-10: General requirements for basic safety and essential performance- Collateral Satandard: Requirements for the development of physiologic closed-loop controllers

€91.00

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UNE-EN 62304:2007 CORR:2009

UNE-EN 62304:2007 CORR:2009

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Medical device software - Software life-cycle processes

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UNE 20611:1979

UNE 20611:1979

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BASICS ASPECTS OF THE SAFETY PHILOSOPHY OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE

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UNE 20901:1995

UNE 20901:1995

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GUIDELINES FOR ADMINISTRATIVE, MEDICAL AND NURSING STAFF CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL EQUIPMENT.

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DIN EN ISO 15378/A1:2024-05

DIN EN ISO 15378/A1:2024-05

Superseded Historical

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024); German and English version EN ISO 15378:2017/prA1:2024

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DIN EN ISO 15223-1/ A1:2024-06

DIN EN ISO 15223-1/ A1:2024-06

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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1 (ISO 15223-1:2021/DAM 1:2024); German and English version EN ISO 15223-1:2021/prA1:2024

€41.78

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IEC 60601-1:2005/ISH2:2009

IEC 60601-1:2005/ISH2:2009

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IEC 60601-1:2005/ISH2:2009 Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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IEC 80601-2-35:2009

IEC 80601-2-35:2009

Superseded Historical

IEC 80601-2-35:2009 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

€441.00

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IEC 60601-1-6:2010

IEC 60601-1-6:2010

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IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

€244.00

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IEC 60601-1-11:2010

IEC 60601-1-11:2010

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IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

€389.00

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IEC 80001-1:2010

IEC 80001-1:2010

Superseded Historical

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

€342.00

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IEC 80601-2-35:2009/COR1:2012

IEC 80601-2-35:2009/COR1:2012

Superseded Historical

IEC 80601-2-35:2009/COR1:2012 Corrigendum 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

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