ГОСТ Р ИСО 20696—2022
Библиография
Biological evaluation of medical devices
[1]
ISO 10993 (all parts)
[2]
ISO 11135
Sterilization of health-care products — Ethylene oxide — Requirements for the
development, validation and routine control of a sterilization process for medical devices
[3]
ISO 11137 (all parts)
Sterilization of health care products — Radiation
[4]
ISO 11607 (all parts)
Packaging for terminally sterilized medical devices
[5]
ISO 15223-1
Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
[6]
ISO 17665
Sterilization of health care products — Moist heat
[7]
ISO/TR 19244
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for
administration of medicinal products and catheters
[8]
EN 556-1:2001
Sterilization of medical devices — Requirements for medical devices to be designated
«STERILE» — Part 1: Requirements for terminally sterilized medical devices
Symbols for use in the labelling of medical devices1)
[9]
EN 980,
[10]EN 1041
Terminology, symbols and information provided with medical devices: Information supplied
by the manufacturer of medical devices
[11]ASTM F640—2007
Standard test methods for radiopacity for medical use
Standard Specification for ureteral stents
[12] ASTM F1828—97
[13] ASTM F1842—09
Standard Test Method for Determining Ink or Coating Adhesion on Flexible Substrates for
a Membrane Switch or Printed Electronic Device
[14]ASTM F2052
Standard Test Method for Measurement of Magnetically Induced Displacement Force on
Medical Devices in the Magnetic Resonance Environment
[15]ASTM F2119
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
[16]ASTM F2182
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near
Passive Implants During Magnetic Resonance Imaging
[17]ASTM F2213
Standard Test Method for Measurement of Magnetically Induced Torque on Medical
Devices in the Magnetic Resonance Environment
[18]ASTM F2252—13
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials
Using Tape
[19]DIN 13273-7
Catheters for medical use — Part 7: Determination of the x-ray attenuation of catheters;
Requirements and testing
[20]ISO 20697
Sterile drainage catheters and accessory devices for single use
1) Отозван
27