SIST EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)

2021-04-26_JO: BT N 12459 and BT168/DG12120/DV to decouple from  Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations 2017/745

Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO 20417:2021)

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 20417:2021)

Medicinski pripomočki - Informacije, ki jih pridobi (zagotovi ???) proizvajalec (ISO/FDIS 20417:2020) TC: Medicinski pripomočki - Informacije, ki jih predloži proizvajalec (ISO 20417:2021)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 20417:2019
01-maj-2019
0HGLFLQVNLSULSRPRþNL,QIRUPDFLMHNLMLKSULGRELSURL]YDMDOHF,62',6


Medical Devices - Information to be provided by the manufacturer (ISO/DIS 20417:2019)

Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO/DIS

20417:2019)

Dispositifs médicaux - Informations à fournir par le fabricant (ISO/DIS 20417:2019)

Ta slovenski standard je istoveten z: prEN ISO 20417
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 20417:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 20417:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 20417:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20417
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-03-19 2019-06-11
Medical devices — Information to be provided by the
manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
ICS: 11.040.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20417:2019(E)
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. ISO 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
© ISO 2019 – All rights reserved 3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
1 Contents

2 Foreword .......................................................................................................................................................................... 6

3 Introduction..................................................................................................................................................................... 7

4 1 Scope .................................................................................................................................................................... 8

5 2 Normative references .................................................................................................................................... 8

6 3 Terms and definitions................................................................................................................................. 10

7 4 General process requirements ................................................................................................................. 16

8 4.1 Usability ............................................................................................................................................................................... 16

9 4.2 Risk management ............................................................................................................................................................. 17

10 5 General requirements ................................................................................................................................ 17

11 5.1 Units of measurement .................................................................................................................................................... 17

12 5.2 Symbols and colours ....................................................................................................................................................... 17

13 5.3 Language and country identifiers ............................................................................................................................. 18

14 5.3.1 Language identifiers ....................................................................................................................................................... 18

15 5.3.2 Country identifiers .......................................................................................................................................................... 18

16 5.4 Dates ..................................................................................................................................................................................... 18

17 5.5 Full address ....................................................................................................................................................................... 19

18 5.6 Authorized representative ........................................................................................................................................... 19

19 6 Medical device identification .................................................................................................................... 19

20 6.1 Commercial product name ........................................................................................................................................... 19

21 6.2 Model number .................................................................................................................................................................... 19

22 6.3 Catalogue number ............................................................................................................................................................ 19

23 6.4 Software .............................................................................................................................................................................. 20

24 6.5 Production identifier ..................................................................................................................................................... 20

25 6.6 Unique device identification ....................................................................................................................................... 20

26 6.7 Types of reuse ................................................................................................................................................................... 20

27 6.8 Sterile ................................................................................................................................................................................... 21

28 7 Requirements for packaging .................................................................................................................... 21

29 7.1 General packaging ........................................................................................................................................................... 21

30 7.2 Packaging for lay user .................................................................................................................................................... 23

31 7.3 Special conditions indicated on packaging ............................................................................................................ 23

32 8 Requirements for information on the label and marking.............................................................. 24

33 8.1 Requirements for the label .......................................................................................................................................... 24

34 8.1.1 Minimum requirements for the label ....................................................................................................................... 24

35 8.1.2 Identification of the manufacturer ............................................................................................................................ 25

36 8.1.3 Identification of the medical device or accessory ................................................................................................. 25

37 8.1.4 Additional label requirements ................................................................................................................................... 27

38 8.2 Consult instructions for use .......................................................................................................................................... 29

39 8.3 Safety signs ......................................................................................................................................................................... 29

40 8.4 Legibility of the label and markings ......................................................................................................................... 30

41 8.5 Durability of markings ................................................................................................................................................... 30

42 9 Requirements for accompanying documentation ............................................................................. 31

43 9.1 General ................................................................................................................................................................................ 31

44 9.2 Health technology assessment (HTA) ...................................................................................................................... 32

45 9.3 Requirements for instructions for use ..................................................................................................................... 32

46 9.3.1 General ................................................................................................................................................................................ 32

47 9.3.2 Requirements for E-documentation .......................................................................................................................... 35

48 9.4 Requirements for technical description .................................................................................................................. 36

4 © ISO 2019 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)

49 10 Information supplied by the manufacturer .......................................................................................... 38

50 10.1 Importer .............................................................................................................................................................................. 38

51 10.2 Distributor .......................................................................................................................................................................... 38

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

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

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

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

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

57 Annex ZA (informative) Relationship between this European standard and the essential

58 requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered .............................................. 61

59 Annex ZB (informative) Relationship between this European standard and the essential

60 requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .................................................. 64

61 Annex ZC (informative) Relationship between this European standard and the essential

62 requirements of Directive 98/79/EC [OJ L 331] aimed to be covered ................................................... 67

63 Annex ZD (informative) Relationship between this European standard and the General Safety and

64 Performance Requirements of Regulation (EU) 2017/745 aimed to be covered ............................... 70

65 Annex ZE (informative) Relationship between this Document and the General Safety and

66 Performance Requirements of Regulation (EU) 2017/746 aimed to be covered ............................... 75

67 Bibliography ................................................................................................................................................................. 82

© ISO 2019 – All rights reserved 5
---------------------- Page: 7 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
69 Foreword

70 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

71 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO

72 technical committees. Each member body interested in a subject for which a technical committee has been

73 established has the right to be represented on that committee. International organizations, governmental and

74 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

75 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

76 The procedures used to develop this document and those intended for its further maintenance are described in

77 the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO

78 documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC

79 Directives, Part 2. www.iso.org/directives

80 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

81 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights

82 identified during the development of the document will be in the Introduction and/or on the ISO list of patent

83 declarations received. www.iso.org/patents

84 Any trade name used in this document is information given for the convenience of users and does not constitute

85 an endorsement.

86 For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as

87 well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see

88 the following URL: Foreword - Supplementary information

89 ISO 20417 was prepared by a Technical Committee ISO/TC 210, Quality management and corresponding

90 general aspects for medical devices.
This is the first edition of ISO 20417.
ISO 20417 replaces EN 1041 [1] .
Numbers in square brackets refer to the Bibliography.
6 © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
94 Introduction

95 This standard provides the common, generic requirements for the design and implementation of labels on

96 medical devices or their packaging, marking of medical devices or accompanying documentation.

97 This document is intended to replace or supplement the often-repetitive labelling requirements that are

98 common among the existing product standards of medical devices. The aim of this document is to serve as a

99 central source of these common, generic requirements, allowing each specific product standard in the future to

100 focus more concisely on the unique requirements for a specific medical device.

101 The requirements of a medical device-specific product standard either supplement or modify these general

102 requirements. Where a product standard exists, this document should not be used separately. Unless specified

103 otherwise within a product standard, the general requirements of this document apply.

104 This document has been prepared to support the essential principles of safety and performance for the

105 information supplied by the manufacturer of a medical device according to ISO 16142 (series).

106 In this document, the following print types are used:
107  Requirements and definitions: roman type.

108  Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative

109 text of tables is also in a smaller type.

110  Test specifications and terms defined in clause 3 of this document or as noted: italic type.

111 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of

112 the conditions is true.

113 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part

114 2. For the purposes of this document, the auxiliary verb:

115  “shall” means that conformance with a requirement or a test is mandatory for conformance with this

116 document;

117  “should” means that conformance with a requirement or a test is recommended but is not mandatory for

118 conformance with this document;

119  “may” is used to describe permission (e.g. a permissible way to achieve conformance with a requirement

120 or test);
121  "can" is used to describe a possibility or capability; and
122  "must" is used to express an external constraint.

123 Annex B contains a compendium of the symbols and safety signs referenced in this document.

124 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there

125 is guidance or rationale related to that item in Annex A.
126
© ISO 2019 – All rights reserved 7
---------------------- Page: 9 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
127 Medical Devices — Information to be provided by the manufacturer
128 1 * Scope

129 This document specifies the requirements for information supplied by the manufacturer for a medical device or

130 accessory, as defined in 3.1. This document includes the generally applicable requirements for identification,

131 marking and documentation of a medical device or accessory. This document does not specify the language to

132 be used for such information, nor does it specify the means by which the information is to be supplied.

133 This document has been prepared to support:

134  the essential principles of safety and performance for the information supplied by the manufacturer of a

135 medical device according to ISO 16142-1:2016 (see Annex C); and

136  the essential principles of safety and performance for the information supplied by the manufacturer of an

137 IVD medical device according to ISO 16142-2:2017 (see Annex C);
138  IMDRF/GRRP WG/N47:2018 [3] (see Annex D); and
139  IMDRF/GRRP WG/N52:— [4] (see Annex D).

140 NOTE Some authorities with jurisdiction impose additional requirements for the identification, marking and

141 documentation of a medical device or accessory.

142 The requirements of a medical device-specific product standard take priority over this document.

143 2 Normative references

144 The following documents, in whole or in part, are normatively referenced in this document and are

145 indispensable for its application. For dated references, only the edition cited applies. For undated references,

146 the latest edition of the referenced document (including any amendments) applies.

147 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in

148 whole or in part) to which they apply.
149 NOTE 2 Informative references are listed in the bibliography.

150 ISO/IEC 646, Information technology – ISO 7-bit coded character set for information interchange

151 ISO 639-1:2002, Codes for the representation of names of languages – Part 1: Alpha-2 Code

152 ISO 639-2:1998, Codes for the representation of names of languages – Part 2: Alpha-3 code

153 ISO 639-3:2007, Codes for the representation of names of languages – Part 3: Alpha-3 code for comprehensive

154 coverage of languages

155 ISO 3166-1:2013, Codes for the representation of names of countries and their subdivisions – Part 1: Country codes

156 ISO 3864-1:2011, Graphical symbols. Safety colours and safety signs. Part 1: Design principles for safety signs and

157 safety markings
158 ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols
8 © ISO 2019 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)

159 ISO 7010:2011, Graphical symbols – Safety colours and safety signs – Registered safety signs

160 +Amendment 1:2012
161 +Amendment 2:2012
162 +Amendment 3:2012
163 +Amendment 4:2013
164 +Amendment 5:2014
165 +Amendment 6:2014
166 +Amendment 7:2016
167 +Amendment 8:2017
168 +Amendment 9:2018

169 ISO 8601:2004, Data elements and interchange formats – Information interchange – Representation of dates and

170 times

171 ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes

172 ISO 14971:— (ed 2), Medical devices – Application of risk management to medical devices

173 ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling and information to

174 be supplied –Part 1: General requirements

175 ISO 15459-2, Information technology – Automatic identification and data capture techniques – Unique

176 identification – Part 2: Registration procedures

177 ISO 15459-4, Information technology – Automatic identification and data capture techniques – Unique

178 identification – Part 4: Individual products and product packages

179 ISO 15459-6, Information technology – Automatic identification and data capture techniques – Unique

180 identification – Part 6: Groupings

181 ISO 16142-1:2016, Medical devices – Recognized essential principles of safety and performance of medical devices

182 – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices

183 and guidance on the selection of standards

184 ISO 16142-2:2017, Medical devices – Recognized essential principles of safety and performance of medical devices

185 – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and

186 guidance on the selection of standards

187 ISO 22742:2010, Packaging – Linear bar code and two-dimensional symbols for product packaging

188 IEC 60417 (database), Graphical symbols for use on equipment

189 IEC 62366-1:2015+AMD1:— , Medical devices – Part 1: Application of the usability engineering process to

190 medical devices
191 ISO 80000-1:2009, Quantities and units – Part 1: General
Under preparation. Stage at the time of publication: ISO FDIS 14971:2019.
Under preparation. Stage at the time of publication: IEC DAMD 62366-1:2019.
© ISO 2019 – All rights reserved 9
---------------------- Page: 11 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
192 3 Terms and definitions

193 For the purposes of this document, the terms and definitions given in ISO 7010:2011, ISO 13485:2016,

194 ISO 14971:—, ISO 16142-1:2016, ISO 16142-2:2017 and IEC 62366-1:2015+AMD1:— and the following

195 definitions apply.

196 NOTE An alphabetized index of defined terms used in this document is found beginning in Annex E.

197 3.1
198 accessory

199 item used together with one or more medical devices to enable or assist a medical device to be used in

200 accordance with its intended use

201 Note 1 to entry: Some authorities having jurisdiction consider an accessory to be a medical device.

202 3.2
203 accompanying information

204 information accompanying or on a medical device or accessory and containing information for the user or those

205 accountable for the installation, use, maintenance, decommissioning and disposal of the medical device or

206 accessory, particularly regarding safe use

207 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.

208 Note 2 to entry: The accompanying information can consist of the instructions for use, technical description, installation

209 manual, quick reference guide, etc.

210 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory,

211 visual, or tactile materials and multiple media types.
212 3.3
213 catalogue number
214 product code

215 letters, numbers or a combination of these assigned by a manufacturer for ordering one or more medical devices

216 or accessories
217 3.4
218 * clearly legible
219 easily legible
220 capable of being read by a person with normal vision
221 [SOURCE: IEC 60601-1:2005+AMD1:2012 [2], definition 3.15]
222 3.5
223 distributor

224 natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device

225 or accessory to the user

226 Note 1 to entry: More than one distributor may be involved in the supply chain.

227 Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and

228 transport on behalf of the manufacturer, importer or distributor, are not distributors.

229 [SOURCE: ISO 13485:2016 [14], definition 3.5, modified –added ‘or accessory’]

10 © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
230 3.7
231
e-documentation
232
electronic documentation

233 any form of electronically accessible information supplied by the manufacturer related to a medical device

234 EXAMPLE CD/DVD-ROM, Internet or other mode
235 Note 1 to entry: See Figure 1.
236
237 NOTE The label includes the packaging of the medical device.

238 Figure 1 – Relationship of terms used to describe information supplied by the manufacturer

239 3.8
240 expected lifetime
241 expected service life

242 time period specified by the manufacturer during which the medical device or accessory is expected to remain

243 safe for use
244 Note 1 to entry: The expected lifetime can be affected by the stability.

245 Note 2 to entry: Maintenance, repairs or upgrades (e.g. safety or cybersecurity modifications) can be necessary during the

246 expected lifetime.

247 [SOURCE: IEC 60601-1:2005+A1:2012, definition 3.28, modified –Added alternative term. The reference to

248 ‘me equipment or me system’ has been replaced with ‘medical device’, the parenthetical has been deleted and

249 the notes added.]
© ISO 2019 – All rights reserved 11
---------------------- Page: 13 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
250 3.9
251 importer

252 natural or legal person in the supply chain who is the first in a supply chain to make a medical device or

253 accessory, manufactured in another country or jurisdiction, available in the country or jurisdiction where it

254 is to be marketed

255 [SOURCE: ISO 13485:2016 [14], definition 3.7, modified –added ‘or accessory’]

256 3.10
257 information for safety

258 information provided to the user or responsible organization that is used as a risk control measure

259 EXAMPLE 1 Warnings, precautions or contraindications.

260 EXAMPLE 2 Instructions in the use of a medical device to prevent use error or avoid a hazardous situation.

261 EXAMPLE 3 Explanation of a safety feature of a medical device.

262 Note 1 to entry: Information for safety can be located on the display of a medical device.

263 3.11
264 information supplied by the manufacturer

265 all information related to the identification and use of a medical device or accessory, in whatever form provided,

266 intended to ensure the safe and effective use of the medical device or accessory

267 Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the

268 manufacturer.

269 Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from

270 information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental

271 information as information supplied by the manufacturer.
272 Note 3 to entry: See Figure 1.
273 3.12
274 instructions for use
275 IFU

276 portion of the accompanying information that is essential for the safe and effective use of a medical device or

277 accessory directed to the user of the medical device

278 Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant

279 spe
...