ГОСТ Р ИСО 25539-2—2012
Библиография
Международные стандарты на медицинские изделия
[1] ISO 7198. Cardiovascular implants — Tubular vascular prostheses
[2] ISO 10555-1. Stenle. single-use intravascular catheters — Part 1: General requirements; Amendment 1:1999;
Amendment 2:2004
[3] ISO10555-2. Sterile, single-use intravascular catheters — Part 2; Angiographic catheters
[4] ISO10555-3. Sterile, single-use intravascular catheters — Part 3: Central venous catheters
[5] ISO10555-4, Sterile, single-use intravascular catheters — Part 4: Balloon dilatation catheters
[6] ISO11070, Sterile single-use intravascular catheter introducers
[7] ISO 11134. Sterilization of health care products — Requirements for validation and routine control — Industrial moist
heat sterilization
[8] ISO/TS 11135-2, Stenlization of health care products— Ethylene oxide — Part 2: Guidance on the application of
ISO 11135-1
[9] ISO 11607-1. Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
[10J ISO 13485. Medical devices — Quality management systems — Requirements for regulatory purposes
[11] ISO/TR 14969. Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003
[12] ISO/TS 15539. Cardiovascular implants — Endovascular prostheses
[13] ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[14] ISO 17475. Corrosion of metals and alloys— Electrochemical test methods — Guidelines for conducting potentiostatic
and potentiodynamic polarization measurements
Европейские стандарты на медицинские изделия
[15] EN 12006-3. Non-active surgical implants — Particular requirements for cardiac and vascular implants — Pari 3:
Endovascular devices
[16] EN 14299. Non-active surgical implants — Particular requirements for cardiac and vascular implants — Specific
requirements for arterial stents
Американские стандарты на медицинские изделия
[17] AAMI ST67, Sterilization of health care products — Requirements for products labeled ’sterile’
[18] ASTM B117, Standard Practice for operating salt spray (Fog) Apparatus
[19] ASTM D638. Standard test method for tensile properties of plastics
[20] ASTM F746. Standard test method for pitting or crevice corrosion of metallic surgical implant materials
[21] ASTM F2052-06e1. Standard test method for measurement of magnetically induced displacement force on medical
devices in the magnetic resonance environment
[22] ASTM F2079. Standard test method for measuring intrinsic elastic recoil of balloon expandable stents
[23] ASTM F2081. Standard guide for characterization and presentation of the dimensional attributes of vascular stents
[24] ASTM F2119-01, Standard test method for evaluation of MR image artifacts from passive implants
[25] ASTM F2129. Standard Test method for conducting cyclic potentiodynamic polarization measurements to determine
the corrosion susceptibility of small implant devices
[26] ASTM F2182-02a. Standard test method for measurement of radio frequency induced heating near passive implants
during magnetic resonance imaging
[27] ASTM F2213-06. Standard test method for measurement of magnetically induced torque on medical devices in the
magnetic resonance environment
[28] ASTM F2394-04. Standard guide for measuring securement of balloon expandable stent mounted on delivery
system
[29] ASTM F2477, Standard test methods for in vitro pulsatile durability testing of vascular stents
[30] ASTM F2503-05. Standard practice for marking medical devices and other items for safety in the magnetic resonance
environment
[31] ASTM G5-94, Standard reference test method for making potentiostatic and potentiodynamic anodic polarization
measurements
[32] ASTM G15-02. Standard terminology relating to corrosion and corrosion testing
[33] ASTM G61. Standard test method for conducting cyclic potentiodynamic polarization measurements for localized
corrosion susceptibility of iron-, nickel-, or cobalt-based alloys
[34] ASTM G102, Standard practice (or calculation of corrosion rates and related information from electrochemical
measurements
72