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11.040.01 Medical equipment in general
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BS EN 60601-1-6:2010+A2:2021
Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard: Usability
Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard: Usability
Released: 2021-08-13
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310.59 USD
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25/30500985 DC
Draft BS EN 63521 Machine Learning-enabled Medical Device. Performance Evaluation Process
Draft BS EN 63521 Machine Learning-enabled Medical Device. Performance Evaluation Process
Released: 2025-05-09
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28.24 USD
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28.24 USD
BS EN 60601-2-62:2015
Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Released: 2015-06-30
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465.88 USD
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PD 6573:1994
Fundamental aspects of safety standards for medical electrical equipment
Fundamental aspects of safety standards for medical electrical equipment
Released: 1994-07-15
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432.00 USD
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BS ISO 15223-2:2010
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation
Released: 2010-06-30
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BS EN 15986:2011
Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
Released: 2011-03-31
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223.06 USD
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223.06 USD
PD IEC/TR 80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
Released: 2012-07-10
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432.00 USD
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432.00 USD
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364.24 USD
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364.24 USD
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465.88 USD
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465.88 USD
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432.00 USD
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BS EN ISO 13485:2016+A11:2021
Medical devices. Quality management systems. Requirements for regulatory purposes
Medical devices. Quality management systems. Requirements for regulatory purposes
Released: 2021-09-08
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PD CEN ISO/TR 24971:2020 - TC
Tracked Changes. Medical devices. Guidance on the application of ISO 14971
Tracked Changes. Medical devices. Guidance on the application of ISO 14971
Released: 2020-08-14
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652.24 USD
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652.24 USD