AAMI 20417 2021:2024 Edition

$172.79

ANSI/AAMI/ISO 20417:2021 Medical devices

Published By	Publication Date	Number of Pages
AAMI	2024	94

Guaranteed Safe Checkout

Category: AAMI

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

Specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information.

PDF Catalog

PDF Pages	PDF Title
1	ANSI/AAMI/ISO 20417:2021; Medical devices—Information to be supplied by the manufacturer
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
8	Background of ANSI/AAMI adoption of ISO 20417:2021
9	Foreword
10	Introduction
11	1 Scope 2 Normative references
12	3 Terms and definitions
13	Figure 1 — Relationship of terms used to describe information supplied by the manufacturer
14	Figure 2 — Relationship of terms used to describe distinct product identification
20	4 General considerations 5 Information elements to be established 5.1 Units of measurement
21	5.2 Graphical information 5.3 Language and country identifiers 5.3.1 Language identifiers
22	5.3.2 Country identifiers 5.4 Dates 5.5 Full address
23	5.6 Commercial product name 5.7 Model number 5.8 Catalogue number 5.9 Production controls 5.10 Unique device identifier
24	5.11 Types of use/reuse 5.12 Sterile 6 Requirements for accompanying information 6.1 Requirements for information to be supplied on the label 6.1.1 Minimum requirements for the label
25	6.1.2 Identification of the manufacturer 6.1.3 Identification of the medical device or accessory
28	6.1.4 Other label requirements
30	6.1.5 Consult instructions for use 6.1.6 Safety signs
31	6.2 Identification requirements for detachable components of a medical device or accessory
32	6.3 Legibility of the label 6.4 Durability of markings 6.5 Information to be provided on the packaging 6.5.1 General information
34	6.5.2 Packaging for the lay user
35	6.5.3 Special conditions indicated on the packaging
36	6.6 Requirements for information in the instructions for use and technical description 6.6.1 General
37	6.6.2 Requirements for instructions for use
42	6.6.3 Additional requirements for the instructions for use for a lay user
43	6.6.4 Requirements for technical description
45	6.6.5 Requirements for e-documentation
46	7 Other information that is required to be supplied with the medical device or accessory 7.1 Importer 7.2 Distributor
47	7.3 Repackaging 7.4 Translation
48	7.5 Regulatory identification
49	Annex A (informative) Particular guidance and rationale A.1 General guidance A.2 General
52	Annex B (informative) Example test method for assessing clearly legible requirements
53	Annex C (informative) Example test method for assessing durability
54	Annex D (informative) Cross reference between the document and the requirements considered Table D.1 — Correspondence between this document and the requirements considered
74	Annex E (informative) Reference to the IMDRF essential principles and labelling guidances Table E.1 — Correspondence between this document and the essential principles
75	Table E.2 — Correspondence between this document and the labelling principles
78	Annex F (informative) Reference to the essential principles Table F.1 — Correspondence between the essential principles for non-IVD medical devices and this document
80	Table F.2 — Correspondence between the essential principles for IVD medical devices and this document
82	Annex G (informative) Reference to the general safety and performance requirements for medical devices Table G.1 — Correspondence between this document and the general safety and performance requirements for medical devices
86	Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices Table H.1 — Correspondence between this document and the general safety and performance requirements for IVD medical devices
90	Annex I (informative) Terminology — Alphabetized index of defined terms
93	Bibliography