{"id":463883,"date":"2024-10-20T10:31:18","date_gmt":"2024-10-20T10:31:18","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-20417-2021\/"},"modified":"2024-10-26T19:23:57","modified_gmt":"2024-10-26T19:23:57","slug":"aami-20417-2021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-20417-2021\/","title":{"rendered":"AAMI 20417 2021"},"content":{"rendered":"

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.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 20417:2021; Medical devices\u2014Information to be supplied by the manufacturer <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 20417:2021 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\nFigure 1 \u2014 Relationship of terms used to describe information supplied by the manufacturer <\/td>\n<\/tr>\n
14<\/td>\nFigure 2 \u2014 Relationship of terms used to describe distinct product identification <\/td>\n<\/tr>\n
20<\/td>\n4 General considerations
5 Information elements to be established
5.1 Units of measurement <\/td>\n<\/tr>\n
21<\/td>\n5.2 Graphical information
5.3 Language and country identifiers
5.3.1 Language identifiers <\/td>\n<\/tr>\n
22<\/td>\n5.3.2 Country identifiers
5.4 Dates
5.5 Full address <\/td>\n<\/tr>\n
23<\/td>\n5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
5.10 Unique device identifier <\/td>\n<\/tr>\n
24<\/td>\n5.11 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 <\/td>\n<\/tr>\n
25<\/td>\n6.1.2 Identification of the manufacturer
6.1.3 Identification of the medical device or accessory <\/td>\n<\/tr>\n
28<\/td>\n6.1.4 Other label requirements <\/td>\n<\/tr>\n
30<\/td>\n6.1.5 Consult instructions for use
6.1.6 Safety signs <\/td>\n<\/tr>\n
31<\/td>\n6.2 Identification requirements for detachable components of a medical device or accessory <\/td>\n<\/tr>\n
32<\/td>\n6.3 Legibility of the label
6.4 Durability of markings
6.5 Information to be provided on the packaging
6.5.1 General information <\/td>\n<\/tr>\n
34<\/td>\n6.5.2 Packaging for the lay user <\/td>\n<\/tr>\n
35<\/td>\n6.5.3 Special conditions indicated on the packaging <\/td>\n<\/tr>\n
36<\/td>\n6.6 Requirements for information in the instructions for use and technical description
6.6.1 General <\/td>\n<\/tr>\n
37<\/td>\n6.6.2 Requirements for instructions for use <\/td>\n<\/tr>\n
42<\/td>\n6.6.3 Additional requirements for the instructions for use for a lay user <\/td>\n<\/tr>\n
43<\/td>\n6.6.4 Requirements for technical description <\/td>\n<\/tr>\n
45<\/td>\n6.6.5 Requirements for e-documentation <\/td>\n<\/tr>\n
46<\/td>\n7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor <\/td>\n<\/tr>\n
47<\/td>\n7.3 Repackaging
7.4 Translation <\/td>\n<\/tr>\n
48<\/td>\n7.5 Regulatory identification <\/td>\n<\/tr>\n
49<\/td>\nAnnex A (informative) Particular guidance and rationale
A.1 General guidance
A.2 General <\/td>\n<\/tr>\n
52<\/td>\nAnnex B (informative) Example test method for assessing clearly legible requirements <\/td>\n<\/tr>\n
53<\/td>\nAnnex C (informative) Example test method for assessing durability <\/td>\n<\/tr>\n
54<\/td>\nAnnex D (informative) Cross reference between the document and the requirements considered
Table D.1 \u2014 Correspondence between this document and the requirements considered <\/td>\n<\/tr>\n
74<\/td>\nAnnex E (informative) Reference to the IMDRF essential principles and labelling guidances
Table E.1 \u2014 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
75<\/td>\nTable E.2 \u2014 Correspondence between this document and the labelling principles <\/td>\n<\/tr>\n
78<\/td>\nAnnex F (informative) Reference to the essential principles
Table F.1 \u2014 Correspondence between the essential principles for non-IVD medical devices and this document <\/td>\n<\/tr>\n
80<\/td>\nTable F.2 \u2014 Correspondence between the essential principles for IVD medical devices and this document <\/td>\n<\/tr>\n
82<\/td>\nAnnex G (informative) Reference to the general safety and performance requirements for medical devices
Table G.1 \u2014 Correspondence between this document and the general safety and performance requirements for medical devices <\/td>\n<\/tr>\n
86<\/td>\nAnnex H (informative) Reference to the general safety and performance requirements for IVD medical devices
Table H.1 \u2014 Correspondence between this document and the general safety and performance requirements for IVD medical devices <\/td>\n<\/tr>\n
90<\/td>\nAnnex I (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
93<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 20417:2021 Medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2024<\/td>\n94<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":463887,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-463883","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/463883","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/463887"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=463883"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=463883"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=463883"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}