This document specifies: \u2014 the general principles governing the biological evaluation of medical devices within a risk management process; \u2014 the general categorization of medical devices based on the nature and duration of their contact with the body; \u2014 the evaluation of existing relevant data from all sources; \u2014 the identification of gaps in the available data set on the basis of a risk analysis; \u2014 the identification of additional data sets necessary to analyse the biological safety of the medical device; \u2014 the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: \u2014 the patient’s body during intended use; \u2014 the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: \u2014 risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; \u2014 breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 General principles applying to biological evaluation of medical devices <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5 Categorization of medical devices 5.1 General 5.2 Categorization by nature of body contact 5.2.1 Non-contacting medical devices <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.2.2 Surface-contacting medical devices 5.2.3 Externally communicating medical devices <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.2.4 Implant medical devices 5.3 Categorization by duration of contact 5.3.1 Contact duration categories 5.3.2 Transitory-contacting medical devices 5.3.3 Medical devices with multiple contact duration categories <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6 Biological evaluation process 6.1 Physical and chemical information for biological risk analysis 6.2 Gap analysis and selection of biological endpoints for assessment <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 6.3 Biological testing 6.3.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 6.3.2 Testing for evaluation <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 7 Interpretation of biological evaluation data and overall biological risk assessment <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex A (informative) Endpoints to be addressed in a biological risk assessment <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Annex C (informative) Suggested procedure for literature review <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Biological evaluation of medical devices – Evaluation and testing within a risk management process<\/b><\/p>\n |