{"id":376372,"date":"2024-10-20T02:47:51","date_gmt":"2024-10-20T02:47:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-204172021-tc\/"},"modified":"2024-10-26T04:56:18","modified_gmt":"2024-10-26T04:56:18","slug":"bs-en-iso-204172021-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-204172021-tc\/","title":{"rendered":"BS EN ISO 20417:2021 – TC"},"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\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\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\ncompares BS EN ISO 20417:2021 <\/td>\n<\/tr>\n
2<\/td>\nTRACKED CHANGES
Text example 1 \u2014 indicates added text (in green) <\/td>\n<\/tr>\n
3<\/td>\nNational foreword
Contractual and legal considerations
Compliance with a British Standard cannot confer immunity from legal obligations. <\/td>\n<\/tr>\n
4<\/td>\nAmendments\/corrigenda issued since publication <\/td>\n<\/tr>\n
6<\/td>\nForewordEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
12<\/td>\nINTERNATIONAL STANDARD
1 Scope
2 Normative references <\/td>\n<\/tr>\n
13<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n3.1
accessory <\/td>\n<\/tr>\n
15<\/td>\n3.2
accompanying information
3.3 <\/td>\n<\/tr>\n
16<\/td>\nFigure 2 \u2014 Relationship of terms used to describe distinct product identification
clearly legible
easily legible
distributor <\/td>\n<\/tr>\n
17<\/td>\n3.6
e-documentation
electronic documentation
3.7
expected lifetime
expected service life
3.8
importer
3.9
information for safety
3.10
information supplied by the manufacturer <\/td>\n<\/tr>\n
18<\/td>\n3.11
instructions for use
IFU
3.12
label
3.13
lay person
3.14
lot
batch <\/td>\n<\/tr>\n
19<\/td>\n3.15
3.16
marking
3.17
model number
model
3.18
multiple patient multiple use
3.19
pictogram
3.20
processing <\/td>\n<\/tr>\n
20<\/td>\n3.21
safety sign
3.22
serial number
3.23
service personnel
3.24
shelf-life
3.25
single patient multiple use
3.26
single use
3.27
stability <\/td>\n<\/tr>\n
21<\/td>\n3.28
sterile
3.29
symbol
3.30
technical description
3.31
UDI carrier <\/td>\n<\/tr>\n
22<\/td>\n4 RequirementsGeneral considerations
4.1 General
4.2 Units, symbols and colours
4.3 Language and country identifiers
4.4 Dates
4.5 Device nomenclature
4.5.1 Identifiers of nomenclature
4.5.2 Device common terms <\/td>\n<\/tr>\n
23<\/td>\n4.5.3 Batch code; lot number; batch number; lot code
5 Requirements for provision of information Information elements to be established
5.1 GeneralUnits of measurement
5.1.1 Safe and effective use of the device <\/td>\n<\/tr>\n
24<\/td>\n5.1.2 Address required under medical devices directives
5.2 Specific requirements Graphical information
5.2.1 Applicability <\/td>\n<\/tr>\n
25<\/td>\n5.2.2 Accessibility
5.2.3 Legibility
5.2.4 Availability
5.2.5 Security
5.2.6 Changes to information provided <\/td>\n<\/tr>\n
26<\/td>\n5.3 Language and country identifiers
5.3.1 Language identifiers
5.3.2 Country identifiers
5.4 Dates <\/td>\n<\/tr>\n
27<\/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
28<\/td>\n5.10 Unique device identifier
5.11 Types of use\/reuse
5.12 Sterile
6.1 Requirements for information to be supplied on the label
6.1.1 Minimum requirements for the label <\/td>\n<\/tr>\n
33<\/td>\n6.1.6 Safety signs <\/td>\n<\/tr>\n
34<\/td>\n6.2 Identification requirements for detachable components of a medical device or accessory <\/td>\n<\/tr>\n
35<\/td>\n6.5 Information to be provided on the packaging
6.5.1 General information <\/td>\n<\/tr>\n
37<\/td>\n6.5.3 Special conditions indicated on the packaging <\/td>\n<\/tr>\n
39<\/td>\n6.6.1 General <\/td>\n<\/tr>\n
48<\/td>\n7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor
7.3 Repackaging <\/td>\n<\/tr>\n
49<\/td>\n7.4 Translation
7.5 Regulatory identification <\/td>\n<\/tr>\n
50<\/td>\nAnnex A <\/td>\n<\/tr>\n
56<\/td>\nA.2 Requirements and guidance for active implantable medical devices (Directive 90\/385\/EEC) <\/td>\n<\/tr>\n
60<\/td>\nAnnex A
This Annex provides rationale for some requirements of this document and is intended for those who are familiar with the subject of this document but who have not participated in its development. An understanding of the rationales underlying these req…
A.2 General
\u2014 Clause 1 \u2013 Scope <\/td>\n<\/tr>\n
62<\/td>\na) 2)
b) 8) <\/td>\n<\/tr>\n
63<\/td>\nAnnex B <\/td>\n<\/tr>\n
64<\/td>\nB.1 Guidance on alternative labelling for medical devices (Directive 93\/42\/EEC) <\/td>\n<\/tr>\n
65<\/td>\nB.2 Guidance on alternative labelling for active implantable medical devices (Directive 90\/385\/EEC) <\/td>\n<\/tr>\n
66<\/td>\nAnnex B <\/td>\n<\/tr>\n
69<\/td>\nAnnex C
Example test method for assessing durability <\/td>\n<\/tr>\n
70<\/td>\nAnnex D
Cross reference between the document and the requirements considered <\/td>\n<\/tr>\n
85<\/td>\nAnnex E <\/td>\n<\/tr>\n
89<\/td>\nAnnex F <\/td>\n<\/tr>\n
93<\/td>\nAnnex G
Reference to the general safety and performance requirements for medical devices <\/td>\n<\/tr>\n
97<\/td>\nAnnex H
Reference to the general safety and performance requirements for IVD medical devices <\/td>\n<\/tr>\n
101<\/td>\nAnnex I
Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
103<\/td>\nBibliography <\/td>\n<\/tr>\n
108<\/td>\nNational foreword <\/td>\n<\/tr>\n
110<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
113<\/td>\nForeword <\/td>\n<\/tr>\n
114<\/td>\nIntroduction <\/td>\n<\/tr>\n
115<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
116<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
123<\/td>\n4 General considerations <\/td>\n<\/tr>\n
124<\/td>\n5 Information elements to be established
5.1 Units of measurement
5.2 Graphical information <\/td>\n<\/tr>\n
125<\/td>\n5.3 Language and country identifiers
5.3.1 Language identifiers
5.3.2 Country identifiers
5.4 Dates <\/td>\n<\/tr>\n
126<\/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
127<\/td>\n5.10 Unique device identifier
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 <\/td>\n<\/tr>\n
128<\/td>\n6.1.2 Identification of the manufacturer <\/td>\n<\/tr>\n
129<\/td>\n6.1.3 Identification of the medical device or accessory <\/td>\n<\/tr>\n
131<\/td>\n6.1.4 Other label requirements <\/td>\n<\/tr>\n
132<\/td>\n6.1.5 Consult instructions for use <\/td>\n<\/tr>\n
133<\/td>\n6.1.6 Safety signs <\/td>\n<\/tr>\n
134<\/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
135<\/td>\n6.5 Information to be provided on the packaging
6.5.1 General information <\/td>\n<\/tr>\n
136<\/td>\n6.5.2 Packaging for the lay user <\/td>\n<\/tr>\n
137<\/td>\n6.5.3 Special conditions indicated on the packaging <\/td>\n<\/tr>\n
138<\/td>\n6.6 Requirements for information in the instructions for use and technical description
6.6.1 General <\/td>\n<\/tr>\n
139<\/td>\n6.6.2 Requirements for instructions for use <\/td>\n<\/tr>\n
144<\/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
147<\/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
148<\/td>\n7.3 Repackaging
7.4 Translation
7.5 Regulatory identification <\/td>\n<\/tr>\n
150<\/td>\nAnnex A (informative) Particular guidance and rationale <\/td>\n<\/tr>\n
153<\/td>\nAnnex B (informative) Example test method for assessing clearly legible requirements <\/td>\n<\/tr>\n
154<\/td>\nAnnex C (informative) Example test method for assessing durability <\/td>\n<\/tr>\n
155<\/td>\nAnnex D (informative) Cross reference between the document and the requirements considered <\/td>\n<\/tr>\n
170<\/td>\nAnnex E (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n
174<\/td>\nAnnex F (informative) Reference to the essential principles <\/td>\n<\/tr>\n
178<\/td>\nAnnex G (informative) Reference to the general safety and performance requirements for medical devices <\/td>\n<\/tr>\n
182<\/td>\nAnnex H (informative) Reference to the general safety and performance requirements for IVD medical devices <\/td>\n<\/tr>\n
186<\/td>\nAnnex I (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
188<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. 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>\n2021<\/td>\n190<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":376382,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-376372","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\/376372","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\/376382"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=376372"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=376372"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=376372"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}