{"id":410775,"date":"2024-10-20T05:41:58","date_gmt":"2024-10-20T05:41:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-204172021-3\/"},"modified":"2024-10-26T10:30:10","modified_gmt":"2024-10-26T10:30:10","slug":"bs-en-iso-204172021-3","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-204172021-3\/","title":{"rendered":"BS EN ISO 20417:2021"},"content":{"rendered":"
\n
\n NOTE 1\n <\/div>\n

There is guidance or rationale for this Clause contained in Clause A.2.<\/p>\n<\/div>\n

This document specifies the requirements for information supplied by the manufacturer<\/i> for a medical device<\/i> or by the manufacturer<\/i> for an accessory<\/i>, as defined in 3.1<\/span>. This document includes the generally applicable requirements for identification and labels<\/i> on a medical device<\/i> or accessory<\/i>, the packaging, marking<\/i> of a medical device<\/i> or accessory,<\/i> and accompanying information<\/i>. This document does not specify the means by which the information is to be supplied.<\/p>\n

\n
\n NOTE 2\n <\/div>\n

Some authorities having jurisdiction<\/i> impose different requirements for the identification, marking<\/i> and documentation of a medical device<\/i> or accessory<\/i>.<\/p>\n<\/div>\n

Specific requirements of medical device<\/i> product standards<\/i> or group standards<\/i> take precedence over requirements of this document.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 General considerations <\/td>\n<\/tr>\n
18<\/td>\n5 Information elements to be established
5.1 Units of measurement
5.2 Graphical information <\/td>\n<\/tr>\n
19<\/td>\n5.3 Language and country identifiers
5.3.1 Language identifiers
5.3.2 Country identifiers
5.4 Dates <\/td>\n<\/tr>\n
20<\/td>\n5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls <\/td>\n<\/tr>\n
21<\/td>\n5.10 Unique device identifier
5.11 Types of use\/reuse
5.12 Sterile <\/td>\n<\/tr>\n
22<\/td>\n6 Requirements for accompanying information
6.1 Requirements for information to be supplied on the label
6.1.1 Minimum requirements for the label
6.1.2 Identification of the manufacturer <\/td>\n<\/tr>\n
23<\/td>\n6.1.3 Identification of the medical device or accessory <\/td>\n<\/tr>\n
25<\/td>\n6.1.4 Other label requirements <\/td>\n<\/tr>\n
26<\/td>\n6.1.5 Consult instructions for use <\/td>\n<\/tr>\n
27<\/td>\n6.1.6 Safety signs <\/td>\n<\/tr>\n
28<\/td>\n6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings <\/td>\n<\/tr>\n
29<\/td>\n6.5 Information to be provided on the packaging
6.5.1 General information <\/td>\n<\/tr>\n
30<\/td>\n6.5.2 Packaging for the lay user <\/td>\n<\/tr>\n
31<\/td>\n6.5.3 Special conditions indicated on the packaging <\/td>\n<\/tr>\n
32<\/td>\n6.6 Requirements for information in the instructions for use and technical description
6.6.1 General <\/td>\n<\/tr>\n
33<\/td>\n6.6.2 Requirements for instructions for use <\/td>\n<\/tr>\n
38<\/td>\n6.6.3 Additional requirements for the instructions for use for a lay user
6.6.4 Requirements for technical description <\/td>\n<\/tr>\n
41<\/td>\n6.6.5 Requirements for e-documentation
7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor <\/td>\n<\/tr>\n
42<\/td>\n7.3 Repackaging
7.4 Translation
7.5 Regulatory identification <\/td>\n<\/tr>\n
44<\/td>\nAnnex A (informative) Particular guidance and rationale <\/td>\n<\/tr>\n
47<\/td>\nAnnex B (informative) Example test method for assessing clearly legible requirements <\/td>\n<\/tr>\n
48<\/td>\nAnnex C (informative) Example test method for assessing durability <\/td>\n<\/tr>\n
49<\/td>\nAnnex D (informative) Cross reference between the document and the requirements considered <\/td>\n<\/tr>\n
65<\/td>\nAnnex E (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n
69<\/td>\nAnnex F (informative) Reference to the essential principles <\/td>\n<\/tr>\n
73<\/td>\nAnnex G (informative) Reference to the general safety and performance requirements for medical devices <\/td>\n<\/tr>\n
77<\/td>\nAnnex H (informative) Reference to the general safety and performance requirements for IVD medical devices <\/td>\n<\/tr>\n
81<\/td>\nAnnex I (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
83<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical devices. Information to be supplied by the manufacturer<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n86<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":410783,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-410775","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/410775","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\/410783"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=410775"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=410775"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=410775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}