AAMI 10993 16 2017

$77.96

ANSI/AAMI/ISO 10993-16:2017

Published By	Publication Date	Number of Pages
AAMI	2017

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Category: AAMI

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Description

This third edition cancels and replaces the second edition (ISO 10993-16:2010), which has been technically revised.

PDF Catalog

PDF Pages	PDF Title
1	ANSI/AAMI/ISO 10993-1:2018; Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
8	Background of ANSI/AAMI adoption of ISO 10993-1:2018
9	Foreword
11	Introduction
13	1 Scope 2 Normative references
14	3 Terms and definitions
18	4 General principles applying to biological evaluation of medical devices
21	Figure 1—Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process
22	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
23	5.2.3 Externally communicating medical devices
24	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
25	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
26	6.3 Biological testing 6.3.1 General
27	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
28	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
29	6.3.2.11 Carcinogenicity 6.3.2.12 Reproductive and developmental toxicity 6.3.2.13 Degradation
30	6.3.2.14 Toxicokinetic studies 6.3.2.15 Immunotoxicology 7 Interpretation of biological evaluation data and overall biological risk assessment
32	Annex A (informative) Endpoints to be addressed in a biological risk assessment A.1 General
33	Table A.1—Endpoints to be addressed in a biological risk assessment
35	A.2 Rationale for endpoints in Table A.1
37	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
38	B.2 Biological evaluation as a risk management practice B.2.1 General
39	B.2.2 The biological evaluation plan
40	Figure B.1—A schematic representation of the risk management process (taken from ISO 14971)
41	B.3 Guidance on risk management B.3.1 Risk assessment B.3.1.1 Introduction B.3.1.2 Risk analysis
42	B.3.1.3 Risk estimation B.3.1.4 Risk evaluation
43	B.3.2 Risk control B.3.3 Evaluation 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
44	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
45	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)
46	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 “sufficient toxicology data” including dose and route relevance B.4.4.3 Determining the acceptability of the level of leachable (allowable limit) according to ISO 10993-17
47	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
48	B.4.5.2 Good laboratory practice B.4.5.3 Biocompatibility evaluation documentation
50	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 Assessment of documents
51	C.2.5 Critical evaluation of the literature
52	Bibliography