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AAMI HE74
|
HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
|
|
AAMI SW68
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES 1ED.
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|
ANSI Z80.3
|
OPHTHALMICS - NONPRESCRIPTION SUNGLASS AND FASHION EYEWEAR REQUIREMENTS
|
|
ASTM 13.01
|
MEDICAL AND SURGICAL MATERIALS AND DEVICES; ANESTHETIC AND RESPIRATORY EQUIPMENT; MANUFACTURE OF PHARMACEUTICAL PRODUCTS
|
|
ASTM F 1980
|
STANDARD GUIDE FOR ACCELARATED AGING OF STERILE BARRIER SYSTEMS FOR MEDICAL DEVICES
|
|
BS EN 1041
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
|
|
BS EN 60601-1-2
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
|
|
BS EN 980
|
SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
|
|
BS EN ISO 14971
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
|
|
DICOM PS 3 SET
|
DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM)
|
|
EEC/93/42
|
COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES *AMENDED BY EEC/2000/70*
|
|
IEC 60601-1
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
|
|
IEC 60601-1-1
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
|
|
IEC 60601-1-2
|
MEDICAL ELECTRICAL EQUIPMENT PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
|
|
IEEE 1073
|
MEDICAL DEVICE COMMUNICATIONS OVERVIEW AND FRAMEWORK
|
|
IEEE 11073-20101
|
HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 20101: APPLICATION PROFILES - BASE STANDARD
|
|
IEEE 11073-30200
|
HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED
|
|
IEEE 11073-30300
|
HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30300: TRANSPORT PROFILE - INFRARED WIRELESS
|
|
ISO 10993-1
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
|
|
ISO 10993-4
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
|
|
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 GAMMA CAMERAS
|
|
NEMA NU 2
|
PERFORMANCE MEASUREMENTS OF POSITRON EMMISION TOMOGRAPHS
|
|
UL 60601-1
|
MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR SAFETY
|
|
UL 94
|
TESTS FOR FLAMMABILITY OF PLASTIC MATERIALS FOR PARTS IN DEVICES AND APPLIANCES
|
