Search results
Search list
Results in:
IEC 80001-1
Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management
Edition
2021-09
IEC 81001-5-1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Edition
2021-12
OENORM EN ISO 7405
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)
Edition
2024-04-15
OENORM EN ISO 7405
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, corrected version 2018-12)
Edition
2019-03-01
OENORM EN ISO 9626
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
Edition
2016-12-15
OENORM EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Edition
2021-04-15
OENORM EN ISO 10993-2
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Edition
2023-04-01
OENORM EN ISO 10993-3
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Edition
2015-01-01
OENORM EN ISO 10993-4
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Edition
2018-01-01
OENORM EN ISO 10993-4/A1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
Edition
2024-04-15