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. Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established
5.1 Units of measurement
5.2 Graphical information
5.3 Language and country identifiers
5.4 Dates
5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
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
6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings
6.5 Information to be provided on the packaging
6.6 Requirements for information in the instructions for use and technical description
7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor
7.3 Repackaging
7.4 Translation
7.5 Regulatory identification
Annex A Particular guidance and rationale (informative)
Annex B Example test method for assessing clearly legible requirements (informative)
Annex C Example test method for assessing durability (informative)
Annex D Cross reference between the document and the requirements considered (informative)
Annex E Reference to the IMDRF essential principles and labelling guidances (informative)
Annex F Reference to the essential principles (informative)
Annex G Reference to the general safety and performance requirements for medical devices (informative)
Annex H Reference to the general safety and performance requirements for IVD medical devices (informative)
Annex I Terminology — Alphabetized index of defined terms (informative)
IEC 60417 (database), Graphical symbols for use on equipment
IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of the usability engineering process to medical devices
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
IEC 60417 (database), Graphical symbols for use on equipment
IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of the usability engineering process to medical devices
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 15223-1:— Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country codes
ISO 3864-1:2011 Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings
ISO 7000 Graphical symbols for use on equipment — Registered symbols
ISO 7010:2019 Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 80000-1 Quantities and units — Part 1: General
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules