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Search Serbian, European and international standards. Identify the standard organization, select the standard number or keyword, and complete the search you want. You can also add a standard drafting stage or a committee / national committee that drafted the standard

General requirements for in vitro diagnostic medical devices for self-testing

90.93 Standard confirmed

Z076 more

Performance evaluation of in vitro diagnostic medical devices

90.93 Standard confirmed

Z076 more

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

90.93 Standard confirmed

Z076 more

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

90.93 Standard confirmed

Z076 more

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

90.93 Standard confirmed

Z076 more

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

60.60 Standard published

Z076 more

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

60.60 Standard published

Z076 more

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

60.60 Standard published

Z076 more

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

90.93 Standard confirmed

Z076 more

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)

60.60 Standard published

Z076 more

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

60.60 Standard published

Z106 more

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)

40.60 Close of voting

Z076 more

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

40.60 Close of voting

ISO/TC 194 more