BIOBURDEN
EN ISO 11737-1 Sterilization of medical devices – Microbiological methods – Part 1: Determination of the population of microorganisms on products
EN ISO 11737-1 Annex B.8 Screening for substances affecting the determination of microbial contamination
Czech Pharmacopoeia – 2.6.12, 2.6.13 Microbiological testing of non-sterile products
STERILITY
EN ISO 11737-2 Sterilization of medical devices – Microbiological methods – Part 2: Sterility tests performed during the definition, validation and maintenance of a sterilization procedure
Czech Pharmacopoeia – 2.6.1 Sterility test
ACCELERATED AGEING
ASTM F1980 Standard for Accelerated Aging of Sterile Barrier Systems for Medical Devices
EFFECTIVENESS OF ANTIMICROBIAL PRESERVATIVES
Czech Pharmacopoeia – 5.1.3. Efficacy of antimicrobial preservatives
CYTOTOXICITY
EN ISO 10993-5 Biological evaluation of medical devices. Part 5: In vitro cytotoxicity tests.
EN ISO 10993-12 Biological evaluation of medical devices. Part 12: Preparation of samples and reference materials.
EN ISO 10993-1 Biological evaluation of medical devices. Part 1: Evaluation and testing as part of the risk management process.
IRRITABILITY
EN ISO 10993-23 Biological evaluation of medical devices. Part 23: Tests for irritation
Bulletin No 761/2009, Annex III, B.46
ANTIMICROBIAL EFFECT
EN ISO 20743:2007 Textiles – Test for antimicrobial activity and efficacy of antibacterially treated products JIS Z 2801 Antimicrobial products – Test for antimicrobial activity and efficacy
TESTING OF PROTECTIVE CLOTHING AGAINST INFECTIOUS AGENTS
EN ISO 22610 Surgical drapes, gowns and surgical suits for cleanroom use as medical devices for patients, hospital staff and equipment – Method for determining resistance to bacterial penetration in wet conditions
EN ISO 22612 Protective clothing against infectious agents – Test method for resistance to microbial penetration in dry conditions
EN 14126 Protective clothing – General requirements and test methods for protective clothing against infectious agents
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