BS ISO 20417:2021 pdf download.Medical devices – Information to be supplied by the manufacturer.
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 ha vi ng 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.
ISL311, Codes for the representation of names of countries and their subdivisions — Part 1:
Country codes
ISO 38644:2011. 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
150 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
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
3.3 catalogue number corn mercial product name commercial product code value given by the manufacturer to identiry a speciiic meaicai device or accessory (J as it relates to its form/fit. function and process (i.e., manufacturing processes requiring differentiation for the end user)
3.4 clearly legible easily legible capable of being read by a person with normal vision
Note I to entry: There is guidance or rationale for this definition contained in Clause A.2.
[SOURCE: IEC 60601-1:2005+AMDI:2012(Zl, 3.15, modified — Note Ito entry added.]
3.5 distributor natural or legal person, different from the manufacturer or importer, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory (3.1) to the user
Note I to entry: More than one distributor may be involved in the supply chain.
Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors.
Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container, wrapper, or accompanying information of the medical device or medical device package other than providing the identification of the distributor.
[SOURCE: ISO 13485:2016, 3.5[7i, modified — added ‘or accessory’and Note 3 to entry.]
3.6 e-documentation electronic documentation any form ol electronically accessible information supplied by the manufacturer (310) related to a medical device or accessory (3.1).
4 General considerations
a) The risk management process of ISO 14971:2019 and the usability engineering process of IEC 62366-1:2015+AMD1:2020 should be used to determine the information, including information br safety, to be provided in the information supplied by the manufacturer.
NOTE Medical device-specific standards can require additional information supplied by the manufacturer.
b) Where this document specifies a specific edition of a normatively referenced document, the manufacturer may substitute a more current version provided the manufacturer can demonstrate that the residual risk that results from the substitution remains acceptable and is comparable to the residual risk that results from applying the normatively referenced document.BS ISO 20417 pdf free download.