Information to be supplied by the manufacturer

BS ISO 20417:2021 pdf free.Medical devices – Information to be supplied by the manufacturer.
IFLI package insert portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory (J) directed to the user of the medical device
Note I to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant specialized training.
Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical device or accessory can be included in the instructions for use.
Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or accessory.
Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use are exempted from having instructions for use by some authorities ha ving jurisdiction.
Note 5 to entry: See Figure 1.
3.12 label <medical device, accessory> written, printed, or graphic information appearing on the item itself, on the packaging of each item or on the packaging of multiple items
Note ito entry: For the purposes of this document, the term labelled is used to designate the corresponding act. Note 2 to entry: Label includes the marking on the medical device or accessory.
Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is considered as appearing on the item.
Note 4 to entry: See Figure 1.
[SOURCE: IMDRF/GRRP WG/N52:2019[41, 3.17, modified —added notes and replaced ‘unit’ and ‘devices’ with ‘item’.
3.13 lay lay person individual who does not have formal education in a relevant field of healthcare or medical discipline and, if appropriate, relevant specialized training on the use of the specific medical device
3.14 lot batch defined amount of material or a number of medical devices, including finished product and accessories (I1) that is manufactured in one process or a series of related processes and is intended to be homogenous.
3.15 lot number batch code batch number lot code production control containing a combination of letters or numbers associated with a single lot (114) or batch (114)
3.16 marking information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device or accessory (3d)
Note Ito entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly described In unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ Is a type of marking.
Note 3 to entry: See Figure 1.
ISOURCE: ISO 18113-1:2009181, 2.4, modified — replaced ‘permanently’ with ‘durably’, deleted notes and added Note I to entry and ‘or accessory’.J
3.17 model number model letters, numbers or a combination of these assigned by a manufacturer to distinguish by function or type, a particular medical device, accessory (11) or medical device family from another Note Ito entry: See Fiaure 2.
3.18 multiple patient multiple use <medical device, accessory> intended by the manufacturer to be reused on multiple patients for multiple uses.
Note 1 to entry: A multiple patient multiple use medical device or accessory typically requires processing between patients.
Note 2 to entry: A multiple patient multiple use medical device or accessory may require processing between uses on a single patient.
3.19 pictogram simplified pictorial representation, used to guide people and tell them how to achieve a certain goal.ISOURCE: ISO/IEC TR 20007:2014(91, 2.10)
3.20 processing <preparation of medical device, accessory> activity to prepare a new or used medical device or accessory for its intended use[SOURCE: ISO 11139:201810], 3.214, modified一added ‘or, accessory’]
3.21 safety sign sign giving a general safety message, obtained by a combination of a colour and geometric shape and which, by the addition of a graphical symbol, gives a particular safety message [SOURCE: ISO 7010:201911], 3.3.
3.22 serial number production control containing a combination of letters or numbers, selected by the manufacturer, intended for quality control and identification purposes to uniquely distinguish an individual medical device from other medical devices with the same catalogue number or model numberSOURCE: ISO 14708-2:20121121, 3.20, modified — added production control containing a, replaced ‘and/or’ with ‘or’ and ‘to distinguish a device from other devices with the same model designation’ with ‘for quality control and identification purposes to distinguish an individual medical device from other medical devices with the same catalogue number or model number’.
3.23 service personnel individuals or entity accountable to the responsible organization that install, assemble, maintain or repair a medical device or accessory (II)
[SOURCE: IEC 60601-l:2005[2i. 3.113. modified — The reference to ‘me equipment, me systems or equipment’ has been replaced by ‘a medical device or accessory’.]
3.24 shelf-life period of time until the expiry date during which a medical device or accessory (ii) in its original packaging maintains its stability under the conditions specified in the information supplied by the manufacturer [SOURCE: IMDRF/GRRP WG/N52:20191&J, 3.36, modified — replaced ‘by the manufacturer’ with ‘in the information supplied by the manufacturer’.]
3.25 single patient multiple use <medical device, accessory> intended by the manufacturer to be reused on an individual patient for multiple uses
Note 1 to entry: A single patient multiple use medical device or accessory may require processing between uses.
Note 2 to entry: For an implantable medical device, the duration of a single use Is from implanting to explanting the medical device.
3.26 single use do not re-use use only once <medical device, accessory> intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of Note ito entry: A single use medical device or accessory is not intended by its manufacturer to be further processed and used again.
3.27 stability <medical device, accessory> ability to maintain safety and performance characteristics within the specifications in injormation supplied by the manufacturer (31O)
Note ito entry: Stability applies to:
— medicaldeviceswhose performance, physical, chemical or functional properties can be altered orcompromised over a stated time interval;
— the period of time over which sterility is assured;
— IVD reagents, calibrators and controls, when stored, transported and used in accordance with conditions specified in the information supplied by the manufacturer
一 reconstituted lyophilized materials, working solutions and material removed from sealed containers, when prepared, used and stored according to the information supplied by the manufacturer; and
一measuring instruments or measuring systems after calibration.
Note 2 to entry: Stability of an IVD reagent or measuring system is normally quantified with respect to time:
一 in terms of the duration of a time interval over which a measured property changes by a stated amount; or
一 in terms of the change of a property under specified conditions.BS ISO 20417 pdf download.BS ISO 22471-2020