FprEN ISO 20417

Medical devices - Information to be supplied by the manufacturer (ISO/FDIS 20417:2020)

2020-01-24-JO-Decision 170/2019 taken by CEN-CLC/JTC 3 on 2019-10-10 to decouple from  Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations 2017/745 and 2017/746

Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO/FDIS 20417:2020)

Dieses Dokument legt die Anforderungen an vom Hersteller bereitgestellte Informationen für ein Medizinprodukt oder Zubehör nach 3.1 fest. Dieses Dokument enthält die allgemein anwendbaren Anforderungen an die Identifizierung und die Etiketten auf einem Medizinprodukt oder Zubehör, an dessen Verpackung, an die Kennzeichnung eines Medizinprodukts oder Zubehörs und an die Begleitinformationen. Dieses Dokument legt nicht fest, auf welche Art und Weise die Informationen bereitzustellen sind.
ANMERKUNG Einige zuständige Behörden stellen andere Anforderungen an die Identifizierung, Kennzeichnung und Dokumentation eines Medizinproduktes oder Zubehörs.
Spezielle Anforderungen von Produktnormen oder Gruppennormen zu Medizinprodukten haben Vorrang vor den Anforderungen dieses Dokuments.

Dispositifs médicaux - Informations à fournir par le fabricant (ISO/FDIS 20417:2020)

Medicinski pripomočki - Informacije, ki jih pridobi (zagotovi ???) proizvajalec (ISO/FDIS 20417:2020) TC: Medicinski pripomočki - Informacije, ki jih predloži proizvajalec

Standards Content (sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.,62',6Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO/DIS 20417:2019)Dispositifs médicaux - Informations à fournir par le fabricant (ISO/DIS 20417:2019)Medical Devices - Information to be provided by the manufacturer (ISO/DIS 20417:2019)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:prEN ISO 20417oSIST prEN ISO 20417:2019en01-maj-2019oSIST prEN ISO 20417:2019SLOVENSKI

STANDARD
oSIST prEN ISO 20417:2019

© ISO 2019Medical devices — Information to be provided by the manufacturerDispositifs médicaux — Informations à fournir par le fabricantICS: 11.040.01Reference numberISO/DIS 20417:2019(E)DRAFT INTERNATIONAL STANDARDISO/DIS 20417ISO/TC 210Secretariat: ANSIVoting begins on: Voting terminates on:2019-03-19 2019-06-11THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.This document is circulated as received from the committee secretariat.ISO/CEN PARALLEL PROCESSINGoSIST prEN ISO 20417:2019

ISO/DIS 20417:2019(E) ii © ISO 2019 – All rights reservedCOPYRIGHT PROTECTED DOCUMENT©

ISO 2019All rights reservedä Unless otherwise speci Ðiedá or required in the context of its implementationá no part of this publication may be reproduced or utilized otherwise in any form or by any meansá electronic or mechanicalá including photocopyingá or posting on the internet or an intranetá without prior written permissionä Permission can be requested from either ISO at the address below or ISOïs member body in the country of the requesteräISO copyright of ÐiceCP 401 • Ch. de Blandonnet 8CH-1214 Vernier, GenevaPhone: [phone]Faxã

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ISO 20417:201(E) © 3 oSIST prEN ISO 20417:2019

Contents 1 Foreword .......................................................................................................................................................................... 6 2 Introduction..................................................................................................................................................................... 7 3 1 Scope .................................................................................................................................................................... 8 4 2 Normative references .................................................................................................................................... 8 5 3 Terms and definitions................................................................................................................................. 10 6 4 General process requirements ................................................................................................................. 16 7 4.1 Usability ............................................................................................................................................................................... 16 8 4.2 Risk management ............................................................................................................................................................. 17 9 5 General requirements ................................................................................................................................ 17 10 5.1 Units of measurement .................................................................................................................................................... 17 11 5.2 Symbols and colours ....................................................................................................................................................... 17 12 5.3 Language and country identifiers ............................................................................................................................. 18 13 5.3.1 Language identifiers ....................................................................................................................................................... 18 14 5.3.2 Country identifiers .......................................................................................................................................................... 18 15 5.4 Dates ..................................................................................................................................................................................... 18 16 5.5 Full address ....................................................................................................................................................................... 19 17 5.6 Authorized representative ........................................................................................................................................... 19 18 6 Medical device identification .................................................................................................................... 19 19 6.1 Commercial product name ........................................................................................................................................... 19 20 6.2 Model number .................................................................................................................................................................... 19 21 6.3 Catalogue number ............................................................................................................................................................ 19 22 6.4 Software .............................................................................................................................................................................. 20 23 6.5 Production identifier ..................................................................................................................................................... 20 24 6.6 Unique device identification ....................................................................................................................................... 20 25 6.7 Types of reuse ................................................................................................................................................................... 20 26 6.8 Sterile ................................................................................................................................................................................... 21 27 7 Requirements for packaging .................................................................................................................... 21 28 7.1 General packaging ........................................................................................................................................................... 21 29 7.2 Packaging for lay user .................................................................................................................................................... 23 30 7.3 Special conditions indicated on packaging ............................................................................................................ 23 31 8 Requirements for information on the label and marking.............................................................. 24 32 8.1 Requirements for the label .......................................................................................................................................... 24 33 8.1.1 Minimum requirements for the label ....................................................................................................................... 24 34 8.1.2 Identification of the manufacturer ............................................................................................................................ 25 35 8.1.3 Identification of the medical device or accessory ................................................................................................. 25 36 8.1.4 Additional label requirements ................................................................................................................................... 27 37 8.2 Consult instructions for use .......................................................................................................................................... 29 38 8.3 Safety signs ......................................................................................................................................................................... 29 39 8.4 Legibility of the label and markings ......................................................................................................................... 30 40 8.5 Durability of markings ................................................................................................................................................... 30 41 9 Requirements for accompanying documentation ............................................................................. 31 42 9.1 General ................................................................................................................................................................................ 31 43 9.2 Health technology assessment (HTA) ...................................................................................................................... 32 44 9.3 Requirements for instructions for use ..................................................................................................................... 32 45 9.3.1 General ................................................................................................................................................................................ 32 46 9.3.2 Requirements for E-documentation .......................................................................................................................... 35 47 9.4 Requirements for technical description .................................................................................................................. 36 48

© oSIST prEN ISO 20417:2019

ISO 20417:201(E) © 5 10 Information supplied by the manufacturer .......................................................................................... 38 49 10.1 Importer .............................................................................................................................................................................. 38 50 10.2 Distributor .......................................................................................................................................................................... 38 51 Annex A (informative)

Particular guidance and rationale ......................................................................... 39 52 Annex B (informative)

Symbols and safety signs for marking .................................................................. 42 53 Annex C (informative)

Reference to the IMDRF essential principles and labelling guidance ........ 48 54 Annex D (informative)

Reference to the essential principles .................................................................... 53 55 Annex E (informative)

Terminology — Alphabetized index of defined terms .................................... 58 56 Annex ZA (informative)

Relationship between this European standard and the essential 57 requirements

of Directive 90/385/EEC [OJ L 189] aimed to be covered .............................................. 61 58 Annex ZB (informative)

Relationship between this European standard and the essential 59 requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .................................................. 64 60 Annex ZC (informative)

Relationship between this European standard and the essential 61 requirements

of Directive 98/79/EC [OJ L 331] aimed to be covered ................................................... 67 62 Annex ZD (informative)

Relationship between this European standard and the General Safety and 63 Performance Requirements of Regulation (EU) 2017/745 aimed to be covered ............................... 70 64 Annex ZE (informative)

Relationship between this Document and the General Safety and 65 Performance Requirements of Regulation (EU) 2017/746 aimed to be covered ............................... 75 66 Bibliography ................................................................................................................................................................. 82 67 68 oSIST prEN ISO 20417:2019

6 © 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information ISO 20417 was prepared by a Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This is the first edition of ISO 20417. ISO 20417 replaces EN 1041 [1] 1. 92 93 1

Numbers in square brackets refer to the Bibliography. oSIST prEN ISO 20417:2019

© 7 Introduction 94 This standard provides the common, generic requirements for the design and implementation of labels on 95 medical devices or their packaging, marking of medical devices or accompanying documentation. 96 This document is intended to replace or supplement the often-repetitive labelling requirements that are 97 common among the existing product standards of medical devices. The aim of this document is to serve as a 98 central source of these common, generic requirements, allowing each specific product standard in the future to 99 focus more concisely on the unique requirements for a specific medical device. 100 The requirements of a medical device-specific product standard either supplement or modify these general 101 requirements. Where a product standard exists, this document should not be used separately. Unless specified 102 otherwise within a product standard, the general requirements of this document apply. 103 This document has been prepared to support the essential principles of safety and performance for the 104 information supplied by the manufacturer of a medical device according to ISO 16142 (series). 105 In this document, the following print types are used: 106  Requirements and definitions: roman type. 107  Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative 108 text of tables is also in a smaller type. 109  Test specifications and terms defined in clause 3 of this document or as noted: italic type. 110 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of 111 the conditions is true. 112 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part 113 2.For the purposes of this document, the auxiliary verb:114  “shall” means that conformance with a requirement or a test is mandatory for conformance with this 115 document; 116  “should” means that conformance with a requirement or a test is recommended but is not mandatory for 117 conformance with this document; 118  “may” is used to describe permission (e.g. a permissible way to achieve conformance with a requirement 119 or test); 120  "can" is used to describe a possibility or capability; and 121  "must" is used to express an external constraint. 122 Annex B contains a compendium of the symbols and safety signs referenced in this document. 123 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there 124 is guidance or rationale related to that item in Annex A. 125 126 oSIST prEN ISO 20417:2019

8 ©

provided by the manufacturer 127 Medical Devices — Information to be1 * Scope 128 This document specifies the requirements for information supplied by the manufacturer for a medical device or 129 accessory, as defined in 3.1. This document includes the generally applicable requirements for identification, 130 marking and documentation of a medical device or accessory. This document does not specify the language to 131 be used for such information, nor does it specify the means by which the information is to be supplied. 132 This document has been prepared to support: 133  the essential principles of safety and performance for the information supplied by the manufacturer of a 134 medical device according to ISO 16142-1:2016 (see Annex C); and 135  the essential principles of safety and performance for the information supplied by the manufacturer of an 136 IVD medical device according to ISO 16142-2:2017 (see Annex C); 137  IMDRF/GRRP WG/N47:2018 [3] (see Annex D); and 138  IMDRF/GRRP WG/N52:— [4] (see Annex D). 139 NOTE Some authorities with jurisdiction impose additional requirements for the identification, marking and 140 documentation of a medical device or accessory. 141 The requirements of a medical device-specific product standard take priority over this document. 142 2 Normative references 143 The following documents, in whole or in part, are normatively referenced in this document and are 144 indispensable for its application. For dated references, only the edition cited applies. For undated references, 145 the latest edition of the referenced document (including any amendments) applies. 146 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in 147 whole or in part) to which they apply. 148 NOTE 2 Informative references are listed in the bibliography. 149 ISO/IEC 646, Information technology – ISO 7-bit coded character set for information interchange 150 ISO 639-1:2002, Codes for the representation of names of languages – Part 1: Alpha-2 Code 151 ISO 639-2:1998, Codes for the representation of names of languages – Part 2: Alpha-3 code 152 ISO 639-3:2007, Codes for the representation of names of languages – Part 3: Alpha-3 code for comprehensive 153 coverage of languages 154 ISO 3166-1:2013, Codes for the representation of names of countries and their subdivisions – Part 1: Country codes 155 ISO 3864-1:2011, Graphical symbols. Safety colours and safety signs. Part 1: Design principles for safety signs and 156 safety markings 157 ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols 158 oSIST prEN ISO 20417:2019

9 ISO 7010:2011, Graphical symbols – Safety colours and safety signs – Registered safety signs 159 +Amendment 1:2012160 +Amendment 2:2012161 +Amendment 3:2012162 +Amendment 4:2013163 +Amendment 5:2014164 +Amendment 6:2014165 +Amendment 7:2016166 +Amendment 8:2017167 +Amendment 9:2018168 ISO 8601:2004, Data elements and interchange formats – Information interchange – Representation of dates and 169 times 170 ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes 171 ISO 14971:—2 (ed 2), Medical devices – Application of risk management to medical devices 172 ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling and information to 173 be supplied –Part 1: General requirements 174 ISO 15459-2, Information technology – Automatic identification and data capture techniques – Unique 175 identification – Part 2: Registration procedures 176 ISO 15459-4, Information technology – Automatic identification and data capture techniques – Unique 177 identification – Part 4: Individual products and product packages 178 ISO 15459-6, Information technology – Automatic identification and data capture techniques – Unique 179 identification – Part 6: Groupings 180 ISO 16142-1:2016, Medical devices – Recognized essential principles of safety and performance of medical devices 181 –Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices182 and guidance on the selection of standards183 ISO 16142-2:2017, Medical devices – Recognized essential principles of safety and performance of medical devices 184 –Part 2: General essential principles and additional specific essential principles for all IVD medical devices and185 guidance on the selection of standards186 ISO 22742:2010, Packaging – Linear bar code and two-dimensional symbols for product packaging 187 IEC 60417 (database), Graphical symbols for use on equipment 188 IEC 62366-1:2015+AMD1:—3, Medical devices – Part 1: Application of the usability engineering process to 189 medical devices 190 ISO 80000-1:2009, Quantities and units – Part 1: General 191 2

Under preparation. Stage at the time of publication: ISO FDIS 14971:2019. 3

Under preparation. Stage at the time of publication: IEC DAMD 62366-1:2019. © oSIST prEN ISO 20417:2019

10 © 192 193 194 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 7010:2011, ISO 13485:2016, ISO 14971:—, ISO 16142-1:2016, ISO 16142-2:2017 and IEC 62366-1:2015+AMD1:— and the following definitions apply. 195 NOTE An alphabetized index of defined terms used in this document is found beginning in Annex E. 196 3.1 197 accessory 198 item used together with one or more medical devices to enable or assist a medical device to be used in 199 accordance with its intended use 200 Note 1 to entry: Some authorities having jurisdiction consider an accessory to be a medical device. 201 3.2 202 accompanying information 203 information accompanying or on a medical device or accessory and containing information for the user or those 204 accountable for the installation, use, maintenance, decommissioning and disposal of the medical device or 205 accessory, particularly regarding safe use 206 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory. 207 Note 2 to entry: The accompanying information can consist of the instructions for use, technical description, installation 208 manual, quick reference guide, etc. 209 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory, 210 visual, or tactile materials and multiple media types. 211 3.3 212 catalogue number 213 product code 214 letters, numbers or a combination of these assigned by a manufacturer for ordering one or more medical devices 215 or accessories 216 3.4 217 *clearly legible218 easily legible219 capable of being read by a person with normal vision220 [SOURCE: IEC 60601-1:2005+AMD1:2012 [2], definition 3.15] 221 3.5 222 distributor 223 natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device 224 or accessory to the user 225 Note 1 to entry: More than one distributor may be involved in the supply chain. 226 Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and 227 transport on behalf of the manufacturer, importer or distributor, are not distributors. 228 [SOURCE: ISO 13485:2016 [14], definition 3.5, modified –added ‘or accessory’] 229 oSIST prEN ISO 20417:2019

© 11 230 231 232 233 234 3.7 e-documentationelectronic documentationany form of electronically accessible information supplied by the manufacturer related to a medical deviceEXAMPLE CD/DVD-ROM, Internet or other mode Note 1 to entry: See Figure 1. 235 236 NOTE The label includes the packaging of the medical device.

237 Figure 1 – Relationship of terms used to describe information supplied by the manufacturer 238 3.8 239 expected lifetime 240 expected service life 241 time period specified by the manufacturer during which the medical device or accessory is expected to remain 242 safe for use 243 Note 1 to entry: The expected lifetime can be affected by the stability. 244 Note 2 to entry: Maintenance, repairs or upgrades (e.g. safety or cybersecurity modifications) can be necessary during the 245 expected lifetime. 246 [SOURCE: IEC 60601-1:2005+A1:2012, definition 3.28, modified –Added alternative term. The reference to 247 ‘me equipment or me system’ has been replaced with ‘medical device’, the parenthetical has been deleted and 248 the notes added.] 249 oSIST prEN ISO 20417:2019

12 © 3.9 250 importer 251 natural or legal person in the supply chain who is the first in a supply chain to make a medical device or 252 accessory, manufactured in another country or jurisdiction, available in the country or jurisdiction where it 253 is to be marketed 254 [SOURCE: ISO 13485:2016 [14], definition 3.7, modified –added ‘or accessory’] 255 3.10 256 information for safety 257 information provided to the user or responsible organization that is used as a risk control measure 258 EXAMPLE 1 Warnings, precautions or contraindications. 259 EXAMPLE 2 Instructions in the use of a medical device to prevent use error or avoid a hazardous situation. 260 EXAMPLE 3 Explanation of a safety feature of a medical device. 261 Note 1 to entry: Information for safety can be located on the display of a medical device. 262 3.11 263 information supplied by the manufacturer 264 all information related to the identification and use of a medical device or accessory, in whatever form provided, 265 intended to ensure the safe and effective use of the medical device or accessory 266 Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the 267 manufacturer. 268 Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from 269 information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental 270 information as information supplied by the manufacturer. 271 Note 3 to entry: See Figure 1. 272 3.12 273 instructions for use 274 IFU 275 portion of the accompanying information that is essential for the safe and effective use of a medical device or 276 accessory directed to the user of the medical device 277 Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant 278 specialized training. 279 Note 2 to entry: For the purposes of this standard, instructions for the professional processing between uses of a medical 280 device or accessory can be included in the instructions for use. 281 Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or 282 communicated from SaMD. 283 Note 4 to entry: Medical devices or accessories that can be used safely without instructions for use are exempted from having 284 instructions for use by some authorities with jurisdiction. 285 Note 5 to entry: See Figure 1. 286 oSIST prEN ISO 20417:2019

13 3.13 287 label 288 written, printed, or graphic information marked on the item itself, or on the 289 packaging of each item, or on the packaging of multiple items 290 Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act. 291 Note 2 to entry: See Figure 1. 292 [SOURCE: IMDRF/GRRP WG/47:2018 [3], definition 3.21, modified –added note] 293 3.14 294 lay 295 lay person 296 term referring to non-professional or professional without relevant 297 specialized training 298 [SOURCE: IEC 60601-1-11:2015 [5], definition 3.3, modified –The reference to ‘operator’ has been replaced 299 with ‘user’.] 300 3.15 301 lot 302 batch 303 defined amount of material or a number of medical devices, including finished product and accessories, that is 304 manufactured in one process or a series of related processes and is homogenous 305 NOTE 1 to entry: A batch or lot is manufactured under essentially the same conditions and is intende

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