This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. This TIR is intended to offer guidance to the medical device industry when evaluating the tendency for medical devices to release particulate, identifying particulate sources, applying analytical methods for particulate testing, and developing particulate limits based on clinical risk.

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1	AAMI TIR42:2021; Evaluation of particulate associated with vascular medical devices
4	AAMI Technical Information Report Copyright information
5	Contents Page
6	Committee representation
7	Foreword
8	Introduction
9	1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references 3 Definitions 3.1 acute application
10	3.2 fiber 3.3 particle 3.4 particulate 3.5 particulate matter 3.6 visible particulate 4 Introduction 5 Key characteristics for evaluation of particulate 5.1 Identity 5.2 Size
11	5.3 Shape 5.4 Quantity 6 Sources of particulate 6.1 Baseline identification of particulate contaminants 6.2 Control of particulate sources
12	6.2.1 Product Design 6.2.1.1 Materials and Coatings 6.2.1.2 Evaluation and Control Method 6.2.1.3 Design Configuration 6.2.1.4 Evaluation and Control Method 6.2.1.5 Packaging 6.2.1.6 Evaluation and Control Method
13	6.2.1.7 Shelf Life 6.2.1.8 Evaluation and Control Method 6.2.2 Manufacturing 6.2.2.1 Components and Raw Materials 6.2.2.2 Evaluation and Control Method 6.2.2.3 Manufacturing Processes 6.2.2.4 Evaluation and Control Method
14	6.2.2.5 Manufacturing Equipment 6.2.2.6 Evaluation and Control Method 6.2.2.7 Manufacturing Personnel 6.2.2.8 Evaluation and Control Method 6.2.2.9 Manufacturing Environment 6.2.2.10 Evaluation and Control Method 6.2.4 Evaluation and Control Method 6.2.3 Sterilization
15	6.2.6 Evaluation and Control Method 6.2.5 Shipping and Distribution 6.2.8 Evaluation and Control Method 6.2.7 Clinical Application and Use 6.3 In-process visual inspection for particulate 7 Particulate evaluation test methods 7.1 General considerations for particulate evaluation 7.1.1 Test environment controls 7.1.2 Test article
16	7.1.3 Sample size 7.1.4 Simulated use model 7.1.5 Simulated use method 7.1.5.1 Considerations for beaker capture measurement
17	7.1.5.2 Considerations for in-line flow measurement 7.1.6 Calibration and validation 7.1.6.1 Counting and sizing equipment calibration 7.1.6.2 Simulated use system validation 7.1.6.3 Considerations 7.1.6.3.1 Reference particle standards
18	7.1.6.3.2 Recovery 7.2 Test methods for determination of size and quantity of particulate 7.2.1 Light Obscuration (LO)
19	7.2.2 Light microscopy using manual or automated counting 7.3 Test methods for chemical identification of particulate and source determination 7.4 Additional considerations and limitations of particulate quantitation and sizing methods 7.4.1 Size/shape
20	7.4.2 Composition 7.4.3 Agglomeration 7.5 Other test method considerations 8 Literature review 8.1 Introduction and scope
21	8.2 Neurovasculature
22	8.3 Cardiovasculature
24	8.4 Pulmonary vasculature
26	8.5 Other/peripheral vasculature
28	8.6 In vitro characterization
29	8.7 Limitations 8.8 Conclusions
30	9 Considerations for establishing quantitative limits for product particulate 9.1 Clinical risk and need for limits
31	9.2 Approaches for determining allowable limits for particulate on an intravascular device 9.2.1 Use of established standards and regulatory guidance documents to justify and establish limits
32	9.2.1.1 Active implantable medical devices 9.2.1.2 USP particulate matter in injections
33	9.2.1.3 Infusion sets and transfusion sets for single use, gravity feed 9.2.1.4 ANSI/AAMI AT6 autologous transfusion devices 9.2.2 Basing limits on comparison to comparable commercially available product
34	9.2.3 Based on correlation to safety in animal study 9.2.4 Basing limits on literature review
35	9.3 Applying benefit/risk principles to particulate limit setting 9.4 Determining appropriate particulate size ranges for evaluation
36	9.5 Maintenance of particulate limits 9.5.1 Re-evaluation of overall device particulate limits 9.5.1.1 Change in intended vascular location or use 9.5.1.2 New clinical data 9.5.1.3 Post-market surveillance trends 9.5.1.4 Changes in standards, device guidance and/or regulatory requirements 9.5.1.5 Changes or improvements in technology
37	9.5.1.6 Particulate reassessment for design and manufacturing changes
38	Annex A Summary of particulate characterization technologies Table A.1—Primary particulate quantitation and sizing technologies
39	Table A.2—Additional particulate quantitation and sizing technologies
40	Table A.3—Particulate chemical identification technologies
42	Bibliography

Published By	Publication Date	Number of Pages
AAMI	2021	47


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Standard Title	AAMI TIR42:2021, Evaluation of particulae associated with vascular medical devices
Published Code	AAMI
Publication Date	2021
Pages Count	47

AAMI TIR42 2021

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