BS EN 592-2002 pdf download.Instructions for use for in vitro diagnostic instruments for self-testing.
This BS EN 592 specifies the requirements for the contents of instructions for use for in vitro diagnostic
instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.
NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.
NOTE 2 This standard can also be applied to accessories
This standard is not applicable to field repair instructions.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest editions of the publication referred to applies (including amendments).
ISO 1000, SI units and recommendations for the use of their multiples arid of certain other units.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
in vitro diagnostic instrument IVD instrument
in vitro diagnostic medical device which is an instrument, apparatus or equipment
NOTE 1 For the definition of an in vitro diagnostic medical device, see [1].
3.4
self-testing
use in the home or similar environments by a lay person who will relate the result of the test to him- or herself
[EN 376:2002)
3.5
specimen
biological material which is obtained In order to detect or to measure one or more quantities [EN 375:20011
4 Form and presentation of the instructions for use
The wording shall be readily understood. Consideration shall be given to the following aspects of presentation. where appropriate:
a) overview of operating elements;
b) flow and block diagrams;
C) integration and arrangement of textillustratioris;
d) graphic emphasis of warnings;
e) examples;
f) diagrams of procedurai steps.
5 Requirements for the content of the Instructions for use
5.1 General
Instructions for use tor IVD instruments shall contain the information given in 5.2 to 5.19. The information provided shall be easy to read and well-organized. The print shall be easily legible and terms simple and not unnecessarily technical or scientific. Symbols and illustrations shall be used wherever possible. A statement that the instructions for use are to be read carefully shall be made
Where appiopnate, instructions for use shall include a table of contents and an index.
The language(s) used shall be (an) official Community language(s), legally acceptable In the country in which the IVD instrument is distributed; additional languages are optional, bearing in mind the needs of the anticipated users.
5.2 Graphical symbols
Any graphical symbols used on the IVD instrument shall be explained in the instructions for use. There are, however, certain well-understood symbols already in use which are recognised to be suitable without need for further explanation, L e. those symbols as so identified in EN 980.
5.3 Manufacturer
The name arid address of the manufacturer shall be given.
NOTE The manufacturer is the entity which has taken the legal responsibility for the IVD Enstwment.
The name and address of the authorized representative shall also be given when this is a legal requirement,
5.4 Identification
The name of the IVD instrument and/or separate instrument components shall be provided.
5.5 Storage and handling
Instructions relevant to any particular storage and/or handling conditions shall be given.
5.6 Warnings and precautions
Any warnings and precautions relevant to any special, unusual risks related to installation, operation, maintenance, transportation, storage or disposal of the IVD instrument shall be given.
5.7 Intended purpose
The intended purpose of the IVD instrument and the fact that it is intended for self-testing shall be clearly stated.
5.8 Installation.BS EN 592-2002 pdf download.