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Criteria: 11.100
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SRPS EN ISO 10993-1:2026  
ISS

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

60.60   Standard published

Z076 more

SRPS EN 13532:2014  
ISS

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

90.60   Close of review

Z076 more

SRPS EN 13612:2008  
ISS

Performance evaluation of in vitro diagnostic medical devices

90.93   Standard confirmed

Z076 more

SRPS EN 13641:2008  
ISS

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

90.60   Close of review

Z076 more

SRPS EN 13975:2008  
ISS

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

90.60   Close of review

Z076 more

SRPS EN 14136:2008  
ISS

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

90.60   Close of review

Z076 more

ISO 10993-1:2025  
ISO

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

60.60   Standard published

ISO/TC 194 more

ISO/DIS 10993-4  
ISO

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

40.20   DIS ballot initiated: 12 weeks

ISO/TC 194 more