relacionadas.
Quadro 9 – Relação das normas ISO aplicáveis aos implantes de quadril
ISO 7206-1 Implants for surgery_- Partial and total hip joint prostheses_- Part_1: Classification and designation of dimensions
ISO 7206-2 Implants for surgery_- Partial and total hip joint prostheses_- Part_2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 7206-4 Implants for surgery_- Partial and total hip joint prostheses_- Part_4:
Determination of endurance properties and performance of stemmed femoral components
ISO 7206-6 Implants for surgery; partial and total hip joint prostheses; part_6: determination of endurance properties of head and neck region of stemmed femoral components ISO 7206-10 Implants for surgery_- Partial and total hip-joint prostheses_- Part_10:
Determination of resistance to static load of modular femoral heads
ISO 14242-1 Implants for surgery_- Wear of total hip-joint prostheses_- Part_1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242-2 Implants for surgery_- Wear of total hip joint prostheses_- Part_2: Methods of measurement
ISO 14242-3 Implants for surgery_- Wear of total hip-joint prostheses_- Part_3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
ISO 17853 Wear of implant materials_- Polymer and metal wear particles_- Isolation and characterization
ISO 21534 Non-active surgical implants_- Joint replacement implants_- Particular requirements
ISO 21535 Non-active surgical implants_- Joint replacement implants_- Specific requirements for hip-joint replacement implants
ISO 14630 Non-active surgical implants_- General requirements FONTE: International Organization for Standardization – ISO
Quadro 10 – Relação das normas ISO referenciadas nas normas aplicáveis aos implantes de quadril. ISO 21534 Non-active surgical implants -- Joint replacement implants -- Particular
requirements
ISO 21535 Non-active surgical implants -- Joint replacement implants -- Specific requirements for hip-joint replacement implants
ISO 4287 Geometrical Product Specifications (GPS) -- Surface texture: Profile method -- Terms, definitions and surface texture parameters
ISO 4288 Geometrical Product Specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
ISO 7206-1 Implants for surgery -- Partial and total hip joint prostheses-- Part 1: Classification and designation of dimensions
ISO 3696 Water for analytical laboratory use -- Specification and test methods
ISO 4965-1 Metallic materials -- Dynamic force calibration for uniaxial fatigue testing-- Part 1: Testing systems
ISO 4965-2 Metallic materials -- Dynamic force calibration for uniaxial fatigue testing-- Part 2: Dynamic calibration device (DCD) instrumentation
ISO 7500-1 Metallic materials -- Verification of static uniaxial testing machines-- Part 1: Tension/compression testing machines -- Verification and calibration of the force- measuring system
ISO 14242-2 Implants for surgery -- Wear of total hip-joint prostheses-- Part 2: Methods of measurement
ISO 14242-1 Implants for surgery -- Wear of total hip-joint prostheses-- Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 7206-4 Implants for surgery -- Partial and total hip joint prostheses-- Part 4: Determination of endurance properties and performance of stemmed femoral components ISO 7206-8 Medical Implant Fatigue Test - Hip joint prostheses Torsion
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice
ISO 14243-2 Implants for surgery -- Wear of total knee-joint prostheses-- Part 2: Methods of measurement
ISO 14630 Non-active surgical implants -- General requirements
ISO 7206-6 Implants for surgery -- Partial and total hip joint prostheses-- Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ISO 7206-10 Implants for surgery -- Partial and total hip-joint prostheses-- Part 10: Determination of resistance to static load of modular femoral heads
ISO 14879-1 Implants for surgery -- Total knee-joint prostheses-- Part 1: Determination of endurance properties of knee tibial trays
ISO 7206-2 Implants for surgery -- Partial and total hip joint prostheses-- Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 8601 Data elements and interchange formats -- Information interchange -- Representation of dates and times
ISO 10993-1 Biological evaluation of medical devices-- Part 1: Evaluation and testing within a risk management process
ISO 11135-1 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1 Sterilization of health care products -- Radiation-- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-1 Packaging for terminally sterilized medical devices-- Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 13408-1 Aseptic processing of health care products-- Part 1: General requirements ISO 14160 Sterilization of health care products -- Liquid chemical sterilizing agents for single-
use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14937 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
ISO 14971 Medical devices -- Application of risk management to medical devices
ISO 17664 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 17665-1 Sterilization of health care products -- Moist heat-- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 22442-1 Medical devices utilizing animal tissues and their derivatives-- Part 1: Application of risk management
ISO 22442-2 Medical devices utilizing animal tissues and their derivatives-- Part 2: Controls on sourcing, collection and handling
ISO 22442-3 Medical devices utilizing animal tissues and their derivatives-- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents ISO 8000-2 Data quality-- Part 2: Vocabulary