11.040.01: Medical equipment in general

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  1. UNE-EN ISO 10993-7:1996▹

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).

    standard by UNE-EN ISO, 05/23/1996.

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  2. UNE-EN ISO 10993-7:1996 ERRATUM▹

    BIOLOGICAL EVAULATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS. (ISO 10993-7:1995).

    standard by UNE-EN ISO, 06/24/1996.

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  3. UNE-EN ISO 10993-7:2009▹

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    standard by UNE-EN ISO, 06/03/2009.

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    Corrigenda: UNE-EN ISO 10993-7:2009/AC:2010

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  4. UNE-EN ISO 10993-7:2009/AC:2010▹

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

    Corrigenda by UNE-EN ISO, 02/24/2010.

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  5. HISTORICAL

    UNE-EN ISO 11197:2005▹

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

    Medical supply units. (ISO 11197:2004)

    standard by UNE-EN ISO, 07/20/2005.

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    Historical Editions: UNE-EN ISO 11197:2009

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  6. UNE-EN ISO 11197:2009▹

    Medical supply units (ISO 11197:2004)

    standard by UNE-EN ISO, 09/02/2009.

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    Historical Editions: UNE-EN ISO 11197:2005

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  7. UNE-ENV 13004:2000▹

    NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSES OF REGULATORY DATA EXCHANGE. RECOMMENDATIONS FOR AN INTERIM SYSTEM AND RULES FOR A FUTURE SYSTEM.

    standard by Asociacion Espanola de Normalizacion y Certificacion (Spanish Standard)/Pre-European Standard, 11/27/2000.

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  8. HISTORICAL

    UNE-EN ISO 13485:2001▹

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

    Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. (ISO 13485:1996)

    standard by UNE-EN ISO, 07/20/2001.

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    Historical Editions: UNE-EN ISO 13485:2004, UNE-EN ISO 13488:2001, UNE-EN 46003:2000

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  9. UNE-EN ISO 13485:2004▹

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

    standard by UNE-EN ISO, 03/12/2004.

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    Corrigenda: UNE-EN ISO 13485:2004 ERRATUM:2009, UNE-EN ISO 13485:2004 ERRATUM:2007, UNE-EN ISO 13485:2004 ERRATUM

    Historical Editions: UNE-EN ISO 13485:2001, UNE-EN ISO 13488:2001, UNE-EN 46003:2000

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  10. UNE-EN ISO 13485:2004 ERRATUM▹

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

    Corrigenda by UNE-EN ISO, 06/25/2004.

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