11.040.01: Medical equipment in general

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  1. HISTORICAL

    ISO 15223-1:2012

    This document has been replaced. View the most recent version.

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

    standard by International Organization for Standardization, 07/01/2012.

    Languages: English

    Historical Editions: ISO 15223-1:2021ISO 15223-1:2016ISO 15223-1/Amd1:2008ISO 15223-1:2007

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  2. HISTORICAL

    ISO 15378:2011 [ Withdrawn ]

    This document has been replaced. View the most recent version.

    Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

    standard by International Organization for Standardization, 11/01/2011.

    Languages: English

    Historical Editions: ISO 15378:2017ISO 15378:2015ISO 15378:2006

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  3. MOST RECENT

    ISO/TS 19218-1:2011 [ Withdrawn ]

    Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes

    standard by International Organization for Standardization (Technical Standard), 05/15/2011.

    Languages: English

    Amendments, rulings, and supplements: ISO/TS 19218-1:2011/Amd1:2013ISO/TS 19218-1:2011/Amd1:2013

    Historical Editions: ISO/TS 19218:2005

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  4. MOST RECENT

    ISO/TS 19218-1:2011/Amd1:2013 [ Withdrawn ]

    Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes- Amendment 1

    Amendment by International Organization for Standardization (Technical Standard), 05/15/2011.

    Languages: English

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  5. MOST RECENT

    ISO/TS 19218-2:2012 [ Withdrawn ]

    Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes

    standard by International Organization for Standardization (Technical Standard), 04/01/2012.

    Languages: English

    Historical Editions: ISO/TS 19218:2005

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  6. IEC/TR 60513 Ed. 2.0 b:1994

    Fundamental aspects of safety standards for medical electrical equipment

    standard by International Electrotechnical Commission - Technical Report, 01/08/1994.

    Languages: English, French

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  7. MOST RECENT

    IEC 60601-1-10 Amd.1 Ed. 1.0 b:2013

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

    Amendment by International Electrotechnical Commission, 11/27/2013.

    Languages: English, French

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  8. MOST RECENT

    IEC 60601-1-10 Amd.2 Ed. 1.0 b:2020

    Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

    Amendment by International Electrotechnical Commission, 07/22/2020.

    Languages: English, French

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  9. HISTORICAL

    IEC 60601-1-10 Ed. 1.0 b:2007

    This document has been replaced. View the most recent version.

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

    standard by International Electrotechnical Commission, 11/21/2007.

    Languages: English, French

    Amendments, rulings, and supplements: IEC 60601-1-10 Amd.2 Ed. 1.0 b:2020IEC 60601-1-10 Amd.1 Ed. 1.0 b:2013

    Historical Editions: IEC 60601-1-10 Ed. 1.2 b:2020IEC 60601-1-10 Ed. 1.1 b:2013

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  10. HISTORICAL

    IEC 60601-1-10 Ed. 1.1 b:2013

    This document has been replaced. View the most recent version.

    Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers CONSOLIDATED EDITION

    standard by International Electrotechnical Commission, 11/27/2013.

    Languages: English, French

    Historical Editions: IEC 60601-1-10 Ed. 1.2 b:2020IEC 60601-1-10 Ed. 1.0 b:2007

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