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ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs |
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DIN EN ISO 15223-1:2015-08 (Draft)
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MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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IEC 60721-3-7:1995+AMD1:1996 CSV
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Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
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IEC 60601-2-30:1999
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Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
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IEC 60601-2-34:2011
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Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
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ISO 21647:2004
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Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
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CR 13825:2000
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Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
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ISO/TR 16142:2006
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Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
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ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
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IEC 60721-3-0:1984+AMD1:1987 CSV
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Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Introduction |
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DIN EN 1707:1997-01
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CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS |
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DIN EN 20594-1:1995-01
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CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS |
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ISO 9919:2005
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Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
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IEC TR 60721-4-7:2001+AMD1:2003 CSV
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Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use |
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ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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ISO 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
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ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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VDE 0750-1 : 2013
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
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ISO 594-1:1986
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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |