欧洲标准组织 |
协调性标准 |
发布于时间 |
被替代的标准 |
被替代标准的终止适用日期 |
CEN |
EN 1865-3:2012 (new) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
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EN 1865:1999 |
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EN 1865-4:2012 (new) Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
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EN 1865:1999 |
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EN 1865-5:2012 (new) Patient handling equipment used in road ambulances - Part 5: Stretcher support |
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EN 1865:1999 |
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EN ISO 5359:2008/A1:2011 (new) |
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EN ISO 11137-2:2012 (new) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012) |
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EN ISO 11137-2:2007 |
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EN ISO 13485:2012 (new) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) |
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EN ISO 13485:2003 |
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EN ISO 13485:2012/AC:2012 (new) |
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EN 13727:2012 (new) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) |
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EN 13727:2003 |
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EN ISO 14971:2012 (new) Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version |
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EN ISO 14971:2009 |
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EN ISO 25539-1:2009/AC:2011 (new) |
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EN ISO 25539-2:2009/AC:2011 (new) |
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EN ISO 81060-1:2012 (new) Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
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EN 1060-2:1995+A1:2009 |
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Cenelec |
EN 60601-2-33:2002/A2:2008/AC:2008(new) |
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EN 60601-2-52:2010/AC:2011 (new) |
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EN 61217:2012 (new) Radiotherapy equipment - Coordinates, movements and scales |
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EN 61217:1996 |
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详情参见:http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
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