BS EN ISO 20417:2021 – TC

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Tracked Changes. Medical devices. Information to be supplied by the manufacturer

Published By	Publication Date	Number of Pages
BSI	2021	190

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Categories: 11.040.01 - Medical equipment in general, BSI

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Description

NOTE 1

There is guidance or rationale for this Clause contained in Clause A.2.

This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. 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. This document does not specify the means by which the information is to be supplied.

NOTE 2

Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.

Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

PDF Catalog

PDF Pages	PDF Title
1	compares BS EN ISO 20417:2021
2	TRACKED CHANGES Text example 1 — indicates added text (in green)
3	National foreword Contractual and legal considerations Compliance with a British Standard cannot confer immunity from legal obligations.
4	Amendments/corrigenda issued since publication
6	ForewordEuropean foreword Endorsement notice
7	Introduction
10	Foreword
11	Introduction
12	INTERNATIONAL STANDARD 1 Scope 2 Normative references
13	3 Terms and definitions
14	3.1 accessory
15	3.2 accompanying information 3.3
16	Figure 2 — Relationship of terms used to describe distinct product identification clearly legible easily legible distributor
17	3.6 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
18	3.11 instructions for use IFU 3.12 label 3.13 lay person 3.14 lot batch
19	3.15 3.16 marking 3.17 model number model 3.18 multiple patient multiple use 3.19 pictogram 3.20 processing
20	3.21 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
21	3.28 sterile 3.29 symbol 3.30 technical description 3.31 UDI carrier
22	4 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
23	4.5.3 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
24	5.1.2 Address required under medical devices directives 5.2 Specific requirements Graphical information 5.2.1 Applicability
25	5.2.2 Accessibility 5.2.3 Legibility 5.2.4 Availability 5.2.5 Security 5.2.6 Changes to information provided
26	5.3 Language and country identifiers 5.3.1 Language identifiers 5.3.2 Country identifiers 5.4 Dates
27	5.5 Full address 5.6 Commercial product name 5.7 Model number 5.8 Catalogue number 5.9 Production controls
28	5.10 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
33	6.1.6 Safety signs
34	6.2 Identification requirements for detachable components of a medical device or accessory
35	6.5 Information to be provided on the packaging 6.5.1 General information
37	6.5.3 Special conditions indicated on the packaging
39	6.6.1 General
48	7 Other information that is required to be supplied with the medical device or accessory 7.1 Importer 7.2 Distributor 7.3 Repackaging
49	7.4 Translation 7.5 Regulatory identification
50	Annex A
56	A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC)
60	Annex 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 — Clause 1 – Scope
62	a) 2) b) 8)
63	Annex B
64	B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC)
65	B.2 Guidance on alternative labelling for active implantable medical devices (Directive 90/385/EEC)
66	Annex B
69	Annex C Example test method for assessing durability
70	Annex D Cross reference between the document and the requirements considered
85	Annex E
89	Annex F
93	Annex G Reference to the general safety and performance requirements for medical devices
97	Annex H Reference to the general safety and performance requirements for IVD medical devices
101	Annex I Terminology — Alphabetized index of defined terms
103	Bibliography
108	National foreword
110	European foreword
113	Foreword
114	Introduction
115	1 Scope 2 Normative references
116	3 Terms and definitions
123	4 General considerations
124	5 Information elements to be established 5.1 Units of measurement 5.2 Graphical information
125	5.3 Language and country identifiers 5.3.1 Language identifiers 5.3.2 Country identifiers 5.4 Dates
126	5.5 Full address 5.6 Commercial product name 5.7 Model number 5.8 Catalogue number 5.9 Production controls
127	5.10 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
128	6.1.2 Identification of the manufacturer
129	6.1.3 Identification of the medical device or accessory
131	6.1.4 Other label requirements
132	6.1.5 Consult instructions for use
133	6.1.6 Safety signs
134	6.2 Identification requirements for detachable components of a medical device or accessory 6.3 Legibility of the label 6.4 Durability of markings
135	6.5 Information to be provided on the packaging 6.5.1 General information
136	6.5.2 Packaging for the lay user
137	6.5.3 Special conditions indicated on the packaging
138	6.6 Requirements for information in the instructions for use and technical description 6.6.1 General
139	6.6.2 Requirements for instructions for use
144	6.6.3 Additional requirements for the instructions for use for a lay user 6.6.4 Requirements for technical description
147	6.6.5 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
148	7.3 Repackaging 7.4 Translation 7.5 Regulatory identification
150	Annex A (informative) Particular guidance and rationale
153	Annex B (informative) Example test method for assessing clearly legible requirements
154	Annex C (informative) Example test method for assessing durability
155	Annex D (informative) Cross reference between the document and the requirements considered
170	Annex E (informative) Reference to the IMDRF essential principles and labelling guidances
174	Annex F (informative) Reference to the essential principles
178	Annex G (informative) Reference to the general safety and performance requirements for medical devices
182	Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices
186	Annex I (informative) Terminology — Alphabetized index of defined terms
188	Bibliography

Additional information

Status	Withdrawn
Pages	190
Publication Date	2021-05-19
ISBN	978 0 539 17839 5
Standard Number	BS EN ISO 20417:2021 – TC
Title	Tracked Changes. Medical devices. Information to be supplied by the manufacturer
Descriptors	Documents, Technical documents, Definitions, Packaging, Medical instruments, Marking, Symbols, Identification methods, Sterile equipment, Implants (surgical), Consumer-supplier relations, Instructions for use, Safety measures, Handbooks, Hazards, Medical equipment
Publisher	BSI
Committee	CH/210
ICS Codes	11.040.01 - Medical equipment in general

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BS EN ISO 20417:2021 – TC

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