Medical Standards

Medical
Let Global Engineering Documents, a division of IHS Engineering, help you stay current with the latest technical standards for the medical field including: EMC/EMI, imaging, injection molding, medical devices, opthalmics, quality, safety, software and sterilization. Whether you need current or historical documents, hardcopy or electronic format, individual or a whole suite of documents - Global delivers!
AAMI HE74 HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
AAMI SW68 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES 1ED.
AAMI TIR12 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR DEVICE MANUFACTURERS
ANSI Z80.3 FOR OPHTHALMICS - NONPRESCRIPTION SUNGLASSES AND FASHION EYEWEAR -REQUIREMENTS
ASTM 13.01 MEDICAL AND SURGICAL MATERIALS AND DEVICES; ANESTHETIC AND RESPIRATORY EQUIPMENT
ASTM F 1980 STANDARD GUIDE FOR ACCELARATED AGING OF STERILE MEDICAL DEVICE PACKAGES
BS EN 1041 INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
BS EN 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FORSAFETY - COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
BS EN 980 GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
BS EN ISO 14971 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
EEC/93/42 COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES
EEC/98/79 COUNCIL REGULATION CONCERNING IN VITRO DIAGNOSTIC MEDICAL DEVICES
IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY
IEC 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
ISO 10993-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ISO 10993-4 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ISO 11607 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
ISO 13485 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 14971 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 15223 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED
ISO/IEC 17025 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATIONLABORATORIES
NEMA NU 1 PERFORMANCE MEASUREMENTS OF SCINTILLATION CAMERAS
NEMA NU 2 PERFORMANCE MEASUREMENTS OF POSITRON EMMISION TOMOGRAPHS
NFPA 99 STANDARD FOR HEALTH CARE FACILITIES
UL 60601-1 MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR SAFETY


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