This document addresses vascular exposure to particles arising from the manufacturing environment for medical devices and from the use of medical devices. This TIR is intended to offer guidance to medical device manufacturers in applying analytical methods for particulate testing, identifying potential sources of particulates, and developing limits for particulates.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI TIR42:2010, Evaluation of particulates associated with vascular medical devices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Technical Information Report Copyright information \n <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 1.1 General 1.2 Inclusion 1.3 Exclusion 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3 Definitions 4 Considerations for evaluating particulates 4.1 General 4.2 Identity 4.3 Size 4.4 Shape <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.5 Quantity 4.6 Test methods 5 Sources of particulates 5.1 Product design 5.1.1 Materials 5.1.2 Design and configuration 5.1.3 Manufacturability <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.1.4 Effect of packaging on device particulates 5.1.5 Effect of sterilization 5.1.6 Effect of shipping and distribution <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.1.7 Effect of shelf storage before use 5.1.8 Clinical use of device 5.2 Manufacturing 5.2.1 General 5.2.2 Particulates from materials 5.2.2.1 Sources <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.2.2.2 Control 5.2.3 Particulates from manufacturing processes 5.2.3.1 Sources 5.2.3.2 Control 5.2.4 Particulates from the environment 5.2.4.1 Airborne particulates 5.2.4.1.1 Sources <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.2.4.1.2 Control 5.2.5 Particulates from personnel 5.2.5.1 Sources 5.2.5.2 Control 5.2.6 Routine particle monitoring and identification during manufacturing 5.2.6.1 Particle monitoring <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.2.6.2 Particle identification 6 Establishment of product particle limits 6.1 Allowable limits for particulates on a device 6.2 Clinical application of device 6.3 Visible particulate matter 6.4 Particle size ranges and particle count limits <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 6.5 Counting methods for fibrous particles 6.6 Alert limit 6.7 Action limit 6.8 Limits for raw materials and components 6.9 Product design 7 Test methods for collection and analysis of particulate matter 7.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 7.2 Airborne particulate matter 7.2.1 Capturing airborne particulate matter for identification 7.2.2 Counting and sizing 7.3 Particulate matter in liquids 7.3.1 Capturing particulate matter in liquids for identification 7.3.2 Counting and sizing <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 7.3.3 Light obscuration counter (LOC) 7.3.3.1 Background 7.3.3.2 Sample preparation 7.3.3.3 Calibration 7.3.3.4 Validation\/verification and system suitability 7.3.3.5 Special considerations 7.3.3.5.1 Gas bubbles 7.3.3.5.2 Immiscible liquids 7.3.3.5.3 Sampling issues <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 7.3.3.5.4 Advantages of light obscuration particle counting 7.3.3.5.5 Disadvantages of light obscuration particle counting 7.3.4 Microscopic method 7.3.4.1 Background <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 7.3.4.2 Sample preparation 7.3.4.3 Microscope calibration 7.3.4.4 Particle enumeration 7.3.4.4.1 Total count procedure 7.3.4.4.2 Partial count procedure <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 7.3.4.5 Analyst training and qualification 7.3.4.5.1 Advantages of the microscopic method 7.3.4.5.2 Disadvantages of the microscopic method 7.4 Characterization of particulate matter <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7.4.1 Sample preparation 7.4.2 Organic analysis 7.4.2.1 Microchemical methods 7.4.2.2 Micro FTIR spectroscopy 7.4.2.3 Micro-Raman spectroscopy 7.4.2.4 Spectral interpretation <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 7.4.2.5 Inorganic analysis 7.4.2.6 X-ray spectroscopy 7.4.3 Other inorganic methods 7.4.4 Morphological analysis 7.4.4.1 Stereomicroscopy 7.4.4.2 Polarized light microscopy <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 7.4.4.3 Electron microscopy 7.4.4.4 References for morphological information 7.4.5 Other analytical techniques 8 Clinical significance of particulate matter 8.1 General <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 8.2 Therapeutic embolization <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 8.3 Microembolization in animals <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 8.4 Foreign body interactions <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 8.5 Conclusion 8.6 References <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 8.7 Annotated bibliography <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Annex A Summary of particulate technologies <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR42:2010 – Evaluation of particulates associated with vascular medical devices<\/b><\/p>\n |