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TNI CEN/TR 17223 (855000)
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Guidance on the relationship between EN ISO 13485: 2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
WITHDRAWN published on 1.3.2019
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STN EN ISO 13485 (855001)
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Medical devices. Quality management systems. Requirements for regulatory purposes
Standard published on 1.3.2017
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STN EN ISO 13485:2017/A11 (855001)
Change
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Medical devices. Quality management systems. Requirements for regulatory purposes
Change published on 1.11.2022
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STN EN ISO 13485:2017/OpravaAC (855001)
Correction
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Medical devices. Quality management systems. Requirements for regulatory purposes
Correction published on 1.2.2019
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STN EN ISO 13485 (855001)
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Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001 (identical to ISO 13485:1996)
WITHDRAWN published on 1.10.2002
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STN EN ISO 13485 (855001)
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Medical devices.Quality management systems.Requirements for regulatory purposes (ISO 13485:2003)
WITHDRAWN published on 1.10.2012
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STN EN ISO 13485 (855001)
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Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2003)
WITHDRAWN published on 1.5.2004
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STN EN ISO 13485 (855001)
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
WITHDRAWN published on 1.7.2016
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STN EN ISO 13488 (855002)
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Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002 (identical to ISO 13488:1996)
WITHDRAWN published on 1.10.2002
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TNI CEN ISO/TR 14969 (855003)
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Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
WITHDRAWN published on 1.2.2013
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