Laboratory testing of medical devices

BIOBURDEN

ČSN EN ISO 11737-1 Sterilization of medical devices – Microbiological methods – Part 1: Determination of the population of microorganisms on products ČSN 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

ČSN 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

ČSN EN ISO 10993-10 Biological evaluation of medical devices. Part 10: Skin irritation and sensitization tests Test on volunteers

Bulletin No 761/2009, Annex III, B.46

Skin irritation in vitro: a test on a reconstructed human epidermis model


ANTIMICROBIAL EFFECT

ČSN 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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