AAMI ISO 11137-2 : 2013
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
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ANSI/AAMI/ISO 10993-3:2014
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
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ANSI/AAMI ST58:2013(R2018)
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CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
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ANSI/AAMI/ISO 11135:2014
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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ASTM D 5587 : 2015 : REDLINE
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TEST METHOD FOR TEARING STRENGTH OF FABRICS BY TRAPEZOID PROCEDURE
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ASTM D 1004 : 2013 : REDLINE
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Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
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ASTM F 1929 : 2015 : REDLINE
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Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
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ISO 604:2002
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Plastics — Determination of compressive properties
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ANSI/AAMI/ISO TIR10993-19:2006
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
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ANSI/AAMI/ISO 10993-12:2012
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
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AAMI ISO 10993-17 : 2002
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
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ANSI/AAMI/ISO TIR16775:2014
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
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ASTM F 1980 : 2016 : REDLINE
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Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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ISO/TR 8550-1:2007
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Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 1: Acceptance sampling
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ANSI/AAMI/ISO 10993-6:2016
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
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ANSI/AAMI/ISO TIR10993-20:2006
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
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ANSI/AAMI ST79:2017
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COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
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ASTM D 1746 : 2015 : REDLINE
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Standard Test Method for Transparency of Plastic Sheeting
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ASTM D 1822 : 2013 : REDLINE
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Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
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AAMI ISO 10993-4 : 2002
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
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ISO 178:2010
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Plastics Determination of flexural properties
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ASTM D 638 : 2014 : REDLINE
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Standard Test Method for Tensile Properties of Plastics
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ISO 6383-1:2015
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Plastics Film and sheeting Determination of tear resistance Part 1: Trouser tear method
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ISO 868:2003
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Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness)
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