This third edition cancels and replaces the second edition (ISO 10993-16:2010), which has been technically revised.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/ISO 10993-1:2018; Biological evaluation of medical devices\u2014Part 1: Evaluation and testing within a risk management process <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Background of ANSI\/AAMI adoption of ISO 10993-1:2018 <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4 General principles applying to biological evaluation of medical devices <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Figure 1\u2014Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process <\/td>\n<\/tr>\n | ||||||
| 22<\/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 5.2.2 Surface-contacting medical devices <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.2.3 Externally communicating medical devices <\/td>\n<\/tr>\n | ||||||
| 24<\/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 | ||||||
| 25<\/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 | ||||||
| 26<\/td>\n | 6.3 Biological testing 6.3.1 General <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 6.3.2 Testing for evaluation 6.3.2.1 Cytotoxicity 6.3.2.2 Sensitization 6.3.2.3 Irritation (including intracutaneous reactivity) 6.3.2.4 Haemocompatibility 6.3.2.5 Material-mediated pyrogenicity <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 6.3.2.6 Acute systemic toxicity 6.3.2.7 Subacute and subchronic toxicity 6.3.2.8 Chronic toxicity 6.3.2.9 Implantation effects 6.3.2.10 Genotoxicity <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 6.3.2.11 Carcinogenicity 6.3.2.12 Reproductive and developmental toxicity 6.3.2.13 Degradation <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.3.2.14 Toxicokinetic studies 6.3.2.15 Immunotoxicology 7 Interpretation of biological evaluation data and overall biological risk assessment <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex A (informative) Endpoints to be addressed in a biological risk assessment A.1 General <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Table A.1\u2014Endpoints to be addressed in a biological risk assessment <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | A.2 Rationale for endpoints in Table A.1 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process B.1 Background information B.1.1 General B.1.2 Relationship with other standards, guidance documents and regulatory requirements <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | B.2 Biological evaluation as a risk management practice B.2.1 General <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | B.2.2 The biological evaluation plan <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Figure B.1\u2014A schematic representation of the risk management process (taken from ISO 14971) <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | B.3 Guidance on risk management B.3.1 Risk assessment B.3.1.1 Introduction B.3.1.2 Risk analysis <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | B.3.1.3 Risk estimation B.3.1.4 Risk evaluation <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | B.3.2 Risk control B.3.3 \u200bEvaluation of residual risk acceptability B.3.4 Post production monitoring B.4 Guidance on specific aspects of biological evaluation B.4.1 Material characterization B.4.1.1 Chemical characterization <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | B.4.1.2 Use of chemical characterization data in a biological evaluation B.4.1.3 Proprietary materials formulations B.4.1.4 Physical Characterization B.4.1.5 Effects of manufacturing processes <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | B.4.2 Collection of existing data B.4.3 Device testing considerations B.4.3.1 Tiered approaches to biological testing B.4.3.2 When to do long-term testing (chronic toxicity, reproductive toxicity, degradation and carcinogenicity studies) <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | B.4.3.3 In vitro system pH and osmolality compensation for absorbable materials B.4.4 Biological safety assessment B.4.4.1 Use of clinically relevant data for a risk assessment B.4.4.2 What constitutes \u201csufficient toxicology data\u201d including dose and route relevance B.4.4.3 Determining the acceptability of the level of leachable (allowable limit) according to ISO 10993-17 <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | B.4.4.4 Thresholds of Toxicological Concern (TTC) B.4.4.5 Guidance on mixtures in risk assessment B.4.5 General guidance B.4.5.1 Changes which can require re-evaluation of biological safety <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | B.4.5.2 Good laboratory practice B.4.5.3 Biocompatibility evaluation documentation <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Annex C (informative) Suggested procedure for literature review C.1 Introduction C.2 Methodology C.2.1 General C.2.2 Objective(s) C.2.3 Selection criteria for documents C.2.4 \u200bAssessment of documents <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | C.2.5 Critical evaluation of the literature <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 10993-16:2017<\/b><\/p>\n |