<![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210 - Quality management and corresponding general aspects for products with a health purpose including medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/committee/05/48/54892.html Normas y proyectos de Ïã¸ÛÁùºÏ²Ê¿ª½± Ïã¸ÛÁùºÏ²Ê¿ª½±.org 60 /modules/isoorg-template/img/iso/favicon/red/favicon1.ico http://www.iso.org/ <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210 - Quality management and corresponding general aspects for products with a health purpose including medical devices]]> <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1:2021/DAmd 1 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/62/86270.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/62/86270.html 2024-08-16 <![CDATA[IEC/CD TS 62366-2 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/88/88848.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/88/88848.html 2024-08-14 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-20 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/27/82712.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/27/82712.html 2024-08-09 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 18250-1:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/72/67284.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/72/67284.html 2024-07-25 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 18250-7:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/97/69729.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/97/69729.html 2024-07-25 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 18250-6:2019 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/97/69731.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/97/69731.html 2024-07-25 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-2:2024 - Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/96/79601.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/96/79601.html 2024-07-02 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/CD TS 5137 - Medical device maintenance management for healthcare delivery organizations]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/62/86275.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/62/86275.html 2024-06-09 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/FDIS 80369-1 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/20/82071.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/20/82071.html 2024-03-21 <![CDATA[IEC/TR 62366-2:2016 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/91/69126.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/91/69126.html 2024-01-15 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/CD TS 24971-2 - Medical devices — Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 14971 — Part 2: Machine learning in artificial intelligence]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/76/87600.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/76/87600.html 2024-01-05 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 23421 - Medical devices — Terminology — Terms used in the field of quality management and corresponding general aspects for products with a health purpose including medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/77/87713.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/77/87713.html 2024-01-05 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 18250-3 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/87/88715.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/87/88715.html 2023-12-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/CD 20417 - Medical devices — Information to be supplied by the manufacturer]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/87/88714.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/87/88714.html 2023-12-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 18250-8:2018/AWI Amd 1 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/87/88716.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/87/88716.html 2023-12-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 20417:2021 - Medical devices — Information to be supplied by the manufacturer]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/79/67943.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/79/67943.html 2023-12-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 18250-3:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/18/61895.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/18/61895.html 2023-12-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 18250-8:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/56/65684.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/56/65684.html 2023-12-03 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/DIS 80369-6 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/54/85462.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/54/85462.html 2023-11-04 <![CDATA[IEC 80369-5:2016 - Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50733.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50733.html 2023-10-13 <![CDATA[IEC/AWI 80369-5 - Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/80/88009.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/80/88009.html 2023-10-13 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50731.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50731.html 2023-09-28 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 16142-1:2016 - 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]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/39/63939.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/39/63939.html 2023-08-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 16142-2:2017 - Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/39/63940.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/39/63940.html 2023-08-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/CD 5137 - Maintenance management program for medical equipment]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/09/80906.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/09/80906.html 2022-12-19 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 - Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation]]> /cms/render/live/es/sites/isoorg/contents/data/standard/04/23/42343.html /cms/render/live/es/sites/isoorg/contents/data/standard/04/23/42343.html 2022-08-26 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 15223-2 - Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/55/85544.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/55/85544.html 2022-08-26 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-6:2016 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50734.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50734.html 2022-08-09 <![CDATA[IEC 62304:2006 - Medical device software — Software life cycle processes]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/84/38421.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/84/38421.html 2021-08-20 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1:2016 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/90/69081.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/90/69081.html 2021-07-06 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/73/77326.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/73/77326.html 2021-07-06 <![CDATA[IEC 62366-1:2015 - Medical devices — Part 1: Application of usability engineering to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/31/63179.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/31/63179.html 2021-06-03 <![CDATA[IEC 80369-5:2016/Cor 2:2021 - Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 2]]> /cms/render/live/es/sites/isoorg/contents/data/standard/08/30/83067.html /cms/render/live/es/sites/isoorg/contents/data/standard/08/30/83067.html 2021-05-31 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-7:2016 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/80/58011.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/80/58011.html 2021-05-04 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/91/79173.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/91/79173.html 2021-05-04 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/38/63837.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/38/63837.html 2021-03-08 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/44/64419.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/44/64419.html 2020-11-05 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-1:2011/Amd 1:2013 - Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/80/58085.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/80/58085.html 2020-10-02 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-2:2012 - Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/55/55590.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/55/55590.html 2020-10-02 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-1:2011 - Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/55/55589.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/55/55589.html 2020-10-02 <![CDATA[IEC 62366-1:2015/Amd 1:2020 - Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/30/73007.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/30/73007.html 2020-07-15 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 20416:2020 - Medical devices — Post-market surveillance for manufacturers]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/79/67942.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/79/67942.html 2020-07-08 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 24971:2013 - Medical devices — Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 14971]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/95/59587.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/95/59587.html 2020-06-16 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 24971:2020 - Medical devices — Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 14971]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/44/74437.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/44/74437.html 2020-06-16 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/97/59752.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/97/59752.html 2020-01-21 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 14971:2007 - Medical devices — Application of risk management to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/81/38193.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/81/38193.html 2019-12-10 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 14971:2019 - Medical devices — Application of risk management to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/27/72704.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/27/72704.html 2019-12-10 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-3:2016/Amd 1:2019 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/40/74038.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/40/74038.html 2019-02-12 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-1:2010 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/04/59/45976.html /cms/render/live/es/sites/isoorg/contents/data/standard/04/59/45976.html 2018-11-05 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15225:2016 - Medical devices — Quality management — Medical device nomenclature data structure]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/30/63016.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/30/63016.html 2017-11-03 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 80002-2:2017 - Medical device software — Part 2: Validation of software for medical device quality systems]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/00/60044.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/00/60044.html 2017-06-13 <![CDATA[IEC 80369-5:2016/Cor 1:2017 - Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/33/73316.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/33/73316.html 2017-02-13 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1:2012 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/03/50335.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/03/50335.html 2016-11-02 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 594-2:1998 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/95/29540.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/95/29540.html 2016-10-14 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 594-1:1986 - Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/00/46/4693.html /cms/render/live/es/sites/isoorg/contents/data/standard/00/46/4693.html 2016-10-14 <![CDATA[IEC 62366-1:2015/Cor 1:2016 - Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/07/20/72042.html /cms/render/live/es/sites/isoorg/contents/data/standard/07/20/72042.html 2016-07-15 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15225:2010 - Medical devices — Quality management — Medical device nomenclature data structure]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50728.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/07/50728.html 2016-03-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 16142:2006 - Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/84/38401.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/84/38401.html 2016-03-09 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2003 - Medical devices — Quality management systems — Requirements for regulatory purposes]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/67/36786.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/67/36786.html 2016-02-24 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004 - Medical devices — Quality management systems — Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485: 2003]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/37/33752.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/37/33752.html 2016-02-24 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2003/Cor 1:2009 - Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/47/54724.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/47/54724.html 2016-02-24 <![CDATA[IEC 62304:2006/Amd 1:2015 - Medical device software — Software life cycle processes — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/46/64686.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/46/64686.html 2015-06-26 <![CDATA[IEC 62366:2007 - Medical devices — Application of usability engineering to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/85/38594.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/85/38594.html 2015-02-25 <![CDATA[IEC 62366:2007/Amd 1:2014 - Medical devices — Application of usability engineering to medical devices — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/27/62780.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/27/62780.html 2015-02-25 <![CDATA[IEC/TR 80002-3:2014 - Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)]]> /cms/render/live/es/sites/isoorg/contents/data/standard/06/56/65624.html /cms/render/live/es/sites/isoorg/contents/data/standard/06/56/65624.html 2014-06-05 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1:2007 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/04/23/42342.html /cms/render/live/es/sites/isoorg/contents/data/standard/04/23/42342.html 2012-06-25 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1:2007/Amd 1:2008 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/04/54/45420.html /cms/render/live/es/sites/isoorg/contents/data/standard/04/54/45420.html 2012-06-25 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218:2005 - Medical devices — Coding structure for adverse event type and cause]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/37/33753.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/37/33753.html 2012-03-20 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15225:2000/Amd 1:2004 - Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/62/36257.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/62/36257.html 2010-04-19 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15225:2000 - Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/64/26495.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/64/26495.html 2010-04-19 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223:2000/Amd 2:2004 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/80/38062.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/80/38062.html 2010-01-15 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223:2000 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/13/31349.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/13/31349.html 2010-01-15 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 15223:2000/Amd 1:2002 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/22/32231.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/22/32231.html 2010-01-15 <![CDATA[IEC/TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 14971 to medical device software]]> /cms/render/live/es/sites/isoorg/contents/data/standard/05/41/54146.html /cms/render/live/es/sites/isoorg/contents/data/standard/05/41/54146.html 2009-09-25 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 20225:2001 - Global medical device nomenclature for the purpose of regulatory data exchange]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/46/34667.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/46/34667.html 2007-11-01 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 14971:2000/Amd 1:2003 - Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/60/36029.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/60/36029.html 2007-02-28 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 14971:2000 - Medical devices — Application of risk management to medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/15/31550.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/15/31550.html 2007-02-28 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:1996 - Quality systems — Medical devices — Particular requirements for the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 9001]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/20/22098.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/20/22098.html 2006-09-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 13488:1996 - Quality systems — Medical devices — Particular requirements for the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 9002]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/21/22101.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/21/22101.html 2006-09-15 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 16142:1999 - Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices]]> /cms/render/live/es/sites/isoorg/contents/data/standard/03/01/30163.html /cms/render/live/es/sites/isoorg/contents/data/standard/03/01/30163.html 2006-01-13 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 14969:1999 - Quality systems — Medical devices — Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485 and Ïã¸ÛÁùºÏ²Ê¿ª½± 13488]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/58/25800.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/58/25800.html 2004-10-18 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½± 14971-1:1998 - Medical devices — Risk management — Part 1: Application of risk analysis]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/57/25799.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/57/25799.html 2000-11-30 <![CDATA[Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 15223:1998 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied]]> /cms/render/live/es/sites/isoorg/contents/data/standard/02/64/26496.html /cms/render/live/es/sites/isoorg/contents/data/standard/02/64/26496.html 2000-04-13