Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018
€98.32
In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide
€208.00
Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
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Point-of-care testing (POCT) — Requirements for quality and competence
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
€115.00
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
€155.00
Medical laboratories — Requirements for safety
€235.00
Guidance for supervisors and operators of point-of-care testing (POCT) devices
Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
€183.00
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Competence requirements for biorisk management advisors
Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
In vitro diagnostic medical devices — Requirements for reference measurement procedures
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices