ГОСТ Р ИСО 18562-1—2022
Библиография
[1]
ISO 10993-9
[2]
ISO 10993-13
[3]
ISO 10993-14
[4]
ISO 10993-15
[5]
ISO 13485:2016
[6]
ISO 16142-1:2016
[7]
ISO/IEC 17025
[8]
IEC 60601-1:2005+
+AMD1:2012
[9]
BS 5724-3.12
Biological evaluation of medical devices — Part 9: Framework for identification and quantifi
cation of potential degradation products
Biological evaluation of medical devices — Part 13: Identification and quantification of degra
dation products from polymeric medical devices
Biological evaluation of medical devices — Part 14: Identification and quantification of degra
dation products from ceramics
Biological evaluation of medical devices — Part 15: Identification and quantification of degra
dation products from metals and alloys
Medical devices — Quality management systems — Requirements for regulatory purposes
Medical devices — Recognized essential principles of safety and performance of medical
devices — Part 1: General essential principles and additional specific essential principles for
all non-IVD medical devices and guidance on the selection of standards
General requirements for the competence of testing and calibration laboratories
Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
Medical electrical equipment — Particular requirements for performance — Method of decla
ring parameters for lung ventilators
[10]Glossary, Scientific Committees of the EU. [accessed 2 May 2016]. Available from:
http://ihcp.jrc.ec.europa.eu/glossary?search_letter=e
[11]US FDA510(k) Memorandum #K97-1, January 10, 1997
[12] Godfrey S. Growth and development of the respiratory system. In: Scientific Foundations
of Paediatrics (Davis J.A., & Dobbing J. eds.). Heinemann, London, Second Edition, 1981,
pp. 432—450
[13]Stocks J. The functional growth and development of the lung during the first year of life. Early
Hum. Dev. 1977, 1 pp. 285—309
[14] Fraunhofer RepDose Database. The database for the analysis of relationship between chemi cal
function groups/categories and target organs in repeated dose studies, [accessed 28 June
2016]. Available from:
http://fraunhofer-repdose.de/
[15] International conference on harmonisation of technical requirements for registration of phar
maceuticals for human use, Assessment and control of DNA reactive (mutagenic) impurities
in pharmaceuticals to limit potential carcinogenic risk ICH M7 Step 4 version, dated 23 June
2014
[16]Miller F.J., Schlosser P.M., Janszen D.B. Haber’s rule: a special case in a family of curves
relating concentration and duration of exposure to a fixed level of response for a given
endpoint. Toxicology. 2000, pp. 21—34
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