11.040.01 : Medical equipment in general

BS EN ISO 13485:2012

BS EN ISO 13485:2012

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Medical devices. Quality management systems. Requirements for regulatory purposes

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25/30466216 DC:2025

25/30466216 DC:2025

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BS EN ISO 18969 Clinical evaluation of medical devices

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25/30551597 DC:2025

25/30551597 DC:2025

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Draft BS IEC 60601-1/FRAG4 ED4 Medical electrical equipment

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25/30528351 DC:2025

25/30528351 DC:2025

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BS EN IEC 60601-2-22:2020/prAA:2025 Medical electrical equipment. Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic diagnostic laser equipment

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25/30528405 DC:2025

25/30528405 DC:2025

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Draft BS EN IEC 60601-1/FRAG11 Medical electrical equipment Part 1. General requirements for basic safety and essential performance. Electromagnetic exposure hazards (Fragment 11)

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ISO/DTS 24971-2.2:2026

ISO/DTS 24971-2.2:2026

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Medical devices — Guidance on the application of ISO 14971 Part 2: Machine learning in artificial intelligence

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BS EN IEC 61847:2025

BS EN IEC 61847:2025

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Ultrasonics. Surgical systems. Measurement and declaration of the basic output characteristics

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25/30528984 DC:2025

25/30528984 DC:2025

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Draft BS EN 60601-1/FRAG10 ED4 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Ionizing radiation hazards (Fragment 10)

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25/30529542 DC:2025

25/30529542 DC:2025

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Draft BS EN IEC 60601-1/FRAG5 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - PEMS related hazards (Fragment 5)

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25/30529546 DC:2025

25/30529546 DC:2025

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Draft BS EN IEC 60601-1/FRAG6 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Electrical hazards (Fragment 6)

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25/30529550 DC:2025

25/30529550 DC:2025

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Draft BS EN IEC 60601-1/FRAG7 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Mechanical hazards (Fragment 7)

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25/30529554 DC:2025

25/30529554 DC:2025

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Draft BS EN IEC 60601-1/FRAG8 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Thermal fire hazards (Fragment 8)

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25/30511190 DC:2025

25/30511190 DC:2025

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Draft BS EN 60601-2-36 Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy

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25/30528988 DC:2025

25/30528988 DC:2025

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Draft BS EN IEC 60601-1/FRAG12. Medical electrical equipment Part 1. General requirements for basic safety and essential performance. Electromagnetic disturbances hazards (Fragment 12)

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25/30502119 DC:2025

25/30502119 DC:2025

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BS EN ISO 11608-1:2022/Amd 1 Needle-based injection systems for medical use —Requirements and test methods Part 1: systems. Amendment

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