eLibrary >
BS EN ISO 10993-4:2017+A1:2025 Biological evaluation of medical devices - Selection of tests for interactions with blood >
Expand All
TOC Search:
BS EN ISO 10993-4:2017+A1:2025 Biological evaluation of medical devices - Selection of tests for interactions with blood, 2025
- undefined
- Annex ZA(informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
- Annex ZB(informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Abbreviated terms
- 5 Types of devices in contact with blood (as categorized in ISO 10993-1)
- 5.1 Non-blood-contact devices
- 5.2 External communicating devices
- 5.2.1 General
- 5.2.2 External communicating devices that serve as an indirect blood path
- 5.2.3 External communicating devices directly contacting circulating blood
- 5.3 Implant devices
- 6 Characterization of blood interactions
- 6.1 General requirements
- 6.2 Categories of tests and blood interactions
- 6.2.1 Recommended tests for interactions of devices with blood
- 6.2.2 Non-contact devices
- 6.2.3 External communicating devices and implant devices
- 6.2.4 Limitations
- 6.3 Types of tests
- 6.3.1 In vitro tests
- 6.3.2 Ex vivo tests
- 6.3.3 In vivo tests
- Annex A (informative) Preclinical evaluation of cardiovascular devices and prostheses
- Annex B (informative) Recommended laboratory tests — Principles, scientific basis and interpretation
- Annex C (informative) Thrombosis — Methods for in vivo testing
- Annex D (informative) Haematology/haemolysis — Methods for testing — Evaluation of haemolytic properties of medical devices and medical device materials
- Annex E (informative) Complement — Methods for testing
- Annex F (informative) Less common laboratory tests
- Annex G (informative) Tests which are not recommended
- Bibliography [Go to Page]
