ГОСТ РИСО 16061—2011
Библиография
[1]ISO 4957 Tool steels
[2]ISO 7151 Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
[3]ISO 7153-1+ISO 7153:1991/Amd 1Surgical instruments — Metallic Materials — Part 1: Stainless steel
[4]ISO 7740 Instruments for surgery — Scalpels with detachable blades — Fitting dimensions
[5] ISO 8319-2 Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws,
screws with cruciate slot and cross-recessed head screws
[6] ISO 10993-12 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management
process
[7]ISO 10993-72 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
[8]ISO 10993-12 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
[9] ISO 10993-13 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation
products from polymeric medical devices
[10] ISO 10993-14 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation
products from ceramics
[11] ISO 10993-15 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation
products from metals and alloys
[12] ISO 10993-18 Biological evaluation of medical devices — Part 18: Chemical characterization of materials
[13] 1ЭОЯ5 10993-19 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topo
graphical characterization of materials
[14] ISO 11138-1 Sterilization of health care products — Biological indicators — Part 1: General requirements
[15] ISO 11138-2Sterilization of health care products — Biological indicators— Part 2: Biological indicators for ethylene
oxide sterilization processes
[16] ISO 11138-3 Sterflization of health care products — Biological indicators — Part 3: Biological indicators for moist
heat sterilization processes
[17] ISO 11140-1 Sterilization of health care products — Chemical indicators — Part 1: General requirements
[18] ISO 11140-3Sterilization of health care products — Chemical indicators— Part 3: Class 2 indicator systems for use
in the Bowie and Dick-type steam penetration test
[19] ISO 11140-4Sterilization ofhealth care products — Chemical indicators—Part 4: Class 2 indicators as an alternative
to the Bowie and Dick-type test for detection of steam penetration
[20] ISO 11140-5 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and
Dick-type air removal tests
[21]ISO 11737-1 Sterilization of medical devices— Microbiological methods — Part 1: Determination of a population of
microorganisms on products
[22] ISO 11737-2Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization process
[23] ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements
[24] ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
[25] ISO 141613 Sterilization of health care products — Biological indicators — Guidance for the selection, use and
interpretation of results
[26] ISO 149373 Sterilization of health care products — General requirements for characterization of a sterilizing agent
and the development, validation and routine control of a sterilization process
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