ГОСТ Р ИСО 18562-4—2022
Библиография
[1]ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
[2] ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and repro
ductive toxicity
[3]ISO 10993-4, Biological evaluation ofmedical devices — Part 4: Selection of tests for interactions with blood
[4]ISO 10993-6, Biological evaluation ofmedical devices — Part 6: Tests for local effects after implantation
[5]ISO 10993-7, Biological evaluation ofmedical devices — Part 7: Ethylene oxide sterilization residuals
[6] ISO 10993-9, Biological evaluation ofmedical devices — Part 9: Framework for identification and quantification of
potential degradation products
[7]ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
[8] ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification ofdegradation
products from polymeric medical devices
[9] ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of degradation
products from ceramics
[10] ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of degradation
products from metals and alloys
[11] ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables
[12] ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for teachable
substances
[13]ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials
[14] ISO/TS 10993-19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topo
graphical characterization of materials
[15] ISO/TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicol-
ogy testing of medical devices
[16] ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of medical devic es
— Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and
guidance on the selection of standards
[17] USP 35 — NF 30, Chapter 233-Elemental impurities-procedures, February 1,2013. Available (viewed 2016-06-28)
at:
http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/key-issues/233— 2s_usp_35—final.pdf
[18] USP 35 — NF 30, Chapter 232-Elemental impurities-limits, February 1,2013. Available (viewed 2016-06-28) at:
http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/key-issues/c232_final.pdf
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