This part of ISO 10993 describes:<\/p>\n
the general principles governing the biological evaluation of medical devices within a risk management process;<\/p>\n<\/li>\n
the general categorization of devices based on the nature and duration of their contact with the body;<\/p>\n<\/li>\n
the evaluation of existing relevant data from all sources;<\/p>\n<\/li>\n
the identification of gaps in the available data set on the basis of a risk analysis;<\/p>\n<\/li>\n
the identification of additional data sets necessary to analyse the biological safety of the medical device;<\/p>\n<\/li>\n
the assessment of the biological safety of the medical device.<\/p>\n<\/li>\n<\/ul>\n
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient’s body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 11<\/td>\n | Scope Normative references <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | General principles applying to biological evaluation of medi <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Categorization of medical devices General Categorization by nature of body contact Surface-contacting devices <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | External communicating devices Implant devices Categorization by duration of contact <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Biological evaluation process Material characterization Biological evaluation tests General <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Test descriptions General Cytotoxicity Delayed-type hypersensitivity Irritation (including intracutaneous reactivity) Systemic toxicity (acute) <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Subacute and subchronic toxicity Genotoxicity Implantation Haemocompatibility Chronic toxicity <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Carcinogenicity Reproductive and developmental toxicity Biodegradation <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Toxicokinetic studies Immunotoxicology <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | Interpretation of biological evaluation data and overall bio <\/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 |