i-Kare iBP-130 User Manual page 5

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Council Directive: 93/42/EEC M5 as amended by 2007/47/EC
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The device complies with R&TTE directive.
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ISO 9001:2008; Quality management Systems – Requirement.
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ISO 13485:2003; Medical devices – Quality management systems – Requirements for regulatory
purposes.
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EN ISO 14971:2012; Medical devices – Application of risk management to medical devices.
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EN 980:2008; Graphical symbols for use in the labeling of medical devices.
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EN 60601‐1:2006+A1:2013; Medical electrical equipment, Part1: General requirements for safety.
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EN60601‐1‐2:2015; Medical electrical equipment – Part1‐2 General requirements for
safety‐collateral standard: Electromagnetic compatibility‐requirements and test.
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EN 60601‐1‐6:2010+A1:2015; Medical electrical equipment ‐‐ Part 1‐6: General requirements for
basic safety and essential performance - Collateral standard: Usability.
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EN60601-1-11:2015; Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.
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EN 1060-3:2009; Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems.
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EN 1060-4:2004; Non-invasive sphygmomanometer.
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ISO10993-1:2009; Biological evaluation of medical devices - Part 1: Evaluation and testing within
a risk management process (ISO 10993-1:2009).
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ISO10993-5:2009; Biological evaluation of medical devices test for in vitro cytotoxicity.
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ISO10993-12:2009; Biological evaluation of medical devices - Part 12: Sample preparation and
reference materials.
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ISO10993-10:2010; Biological evaluation of medical devices - Part 10: Test for irritation and skin
sensitization.
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EN 300 328(2006-10); Radio and telecommunications terminal equipment.
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EN 62366:2008+A1:2015; Application of usability engineering to medical devices
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EN 62304:2006+A1:2015; Software life-cycle processes
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