This document specifies general requirements for evaluating the interactions of medical devices with blood.<\/p>\n
It describes<\/p>\n
a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993\u20111,<\/p>\n<\/li>\n
the fundamental principles governing the evaluation of the interaction of devices with blood,<\/p>\n<\/li>\n
the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.<\/p>\n<\/li>\n<\/ol>\n
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.<\/p>\n
The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4 Abbreviated terms <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5 Types of devices in contact with blood (as categorized in ISO 10993\u20111) 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 <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.3 Implant devices 6 Characterization of blood interactions 6.1 General requirements <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 6.2 Categories of tests and blood interactions 6.2.1 Recommended tests for interactions of devices with blood <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.3.2 Ex vivo tests 6.3.3 In vivo tests <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Annex A (informative) Preclinical evaluation of cardiovascular devices and prostheses <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex B (informative) Recommended laboratory tests \u2014 Principles, scientific basis and interpretation <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Annex C (informative) Thrombosis \u2014 Methods for in vivo testing <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Annex D (informative) Haematology\/haemolysis \u2014 Methods for testing \u2014 Evaluation of haemolytic properties of medical devices and medical device materials <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Annex E (informative) Complement \u2014 Methods for testing <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Annex F (informative) Less common laboratory tests <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | Annex G (informative) Tests which are not recommended <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Biological evaluation of medical devices – Selection of tests for interactions with blood<\/b><\/p>\n |