11.040.01 : Medical equipment in general

BS EN ISO 14971:2001

BS EN ISO 14971:2001

Superseded Historical

Medical devices. Application of risk management to medical devices

€355.00

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DD ISO/TS 19218:2005

DD ISO/TS 19218:2005

Superseded Historical

Medical devices. Coding structure for adverse event type and cause

€193.00

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BS EN 980:2003

BS EN 980:2003

Superseded Historical

Graphical symbols for use in the labelling of medical devices

€269.00

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24/30500890 DC:2024

24/30500890 DC:2024

Active Most Recent

BS EN ISO 20417 Medical devices - Information to be supplied by the manufacturer

€23.00

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24/30506269 DC:2024

24/30506269 DC:2024

Active Most Recent

BS EN IEC 60601-1/FRAG1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - (Fragment 1)

€23.00

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24/30506273 DC:2024

24/30506273 DC:2024

Active Most Recent

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

€23.00

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24/30506277 DC:2024

24/30506277 DC:2024

Active Most Recent

BS EN IEC 60601-1/FRAG2 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Physical environment hazard (Fragment 2)

€23.00

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24/30506281 DC:2024

24/30506281 DC:2024

Active Most Recent

BS EN IEC 60601-1/FRAG3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - User interface hazards (Fragment 3)

€23.00

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24/30506285 DC:2024

24/30506285 DC:2024

Active Most Recent

BS EN IEC 60601-1/FRAG4 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Materials hazards (Fragment 4)

€23.00

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25/30502360 DC:2025

25/30502360 DC:2025

Active Most Recent

BS EN IEC 62304 Health software – Software life cycle processes

€42.00

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BS EN ISO 15378:2017+A1:2024

BS EN ISO 15378:2017+A1:2024

Active Most Recent

Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

€404.00

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BS EN 62353:2008

BS EN 62353:2008

Withdrawn Most Recent

Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment

€374.00

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BS EN ISO 13485:2003

BS EN ISO 13485:2003

Withdrawn Most Recent

Medical devices. Quality management systems. Requirements for regulatory purposes

€404.00

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BS EN 61558-2-15:2001

BS EN 61558-2-15:2001

Withdrawn Most Recent

Safety of power transformers, supply units and similar Particular requirements for isolating transformers the medical locations

€193.00

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PD IEC/TR 60878:2003

PD IEC/TR 60878:2003

Withdrawn Most Recent

Graphical symbols for electrical equipment in medical practice

€404.00

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