ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
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) |
ISO 15223-2:2010
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Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
DIN ISO 2859-1:2014-08
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SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION (ISO 2859-1:1999 + COR. 1:2001 + AMD.1:2011) |
ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
ISO 16038:2005
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Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
DIN EN ISO 10993-5:2009-10
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
ISO 3534-2:2006
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Statistics Vocabulary and symbols Part 2: Applied statistics |
ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
ASTM D 3492 : 2016 : REDLINE
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Standard Specification for Rubber Contraceptives (Male Condoms) |
DIN EN ISO 9000:2015-11
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
DIN EN ISO 10993-10:2014-10
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
ISO 5893:2002
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Rubber and plastics test equipment Tensile, flexural and compression types (constant rate of traverse) Specification |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
DIN EN ISO 11737-1:2009-09
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STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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 |
DIN ISO 3534-2:2013-12
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STATISTICS - VOCABULARY AND SYMBOLS - PART 2: APPLIED STATISTICS (ISO 3534-2:2006) |