BS ISO 20417:2021 pdf download.Medical devices - In formation to be supplied by the manufacturer
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 860 1-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 13485:2016, Medical devices — Quality management systems — Requirementsfor regulatory purposes
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO 15223-1:-i), 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
IEC 60417, (database), Graphical symbols for use on equipment
commercial product code
value given by the manufacturer to identify a specific medical device or accessory (3.1) as it relates to its form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)
Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these.
Note 2 to entry: For the purposes of this document, commercial product code should not be confused with the US FDA 'product code' or procode classification.
Note 3 to entry: Synonyms for catalogue number are "reference number" or "reorder number".
Note 4 to entry: See Figure 2.[SOURCE: IMDRF/GRRP WG/N52:2019[4], 3.2, modified一added 'or accessory' and Notes to entry.].BS ISO 20417 pdf download.