ГОСТ Р ИСО 22413-2021. Национальный стандарт Российской Федерации. Системы для переливания фармацевтических препаратов. Требования и методы испытаний

[1]

ISO 7000, Graphical symbols for use on equipment - Registered symbols

[2]

ISO 7886-1, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

[3]

ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

[4]

ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization

[5]

ISO 8871-3, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count

[6]

ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods

[7]

ISO 23908, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

[8]

DIN 13097-4, Hypodermic needles - Part 4: Point geometry, requirements and testing

[9]

European Pharmacopoeia, http://www.edqm.eu

[10]

United States Pharmacopeia, http://www.usp.org

[11]

Japanese Pharmocopoeia, https://www.pmda.go.jp

УДК 615.473:006.354

ОКС 11.040.20

Ключевые слова: системы для переливания, лекарственные препараты, стерильные, однократное применение, требования, испытания