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Standards [CURRENT]

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

Standards [CURRENT]

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

Draft standard

OENORM EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)
Edition 2024-04-15

Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

OENORM EN ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Edition 2023-04-01

Standards [CURRENT]

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

Standards [CURRENT]

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

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

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