BS EN ISO 11979-4:2008 pdf free

BS EN ISO 11979-4:2008 pdf free.Ophthalmic implants – Intraocular lenses
This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
NOTE This part of ISO 11979 attempts to harmonize the recognized labelling requirements for IOLs throughout the world, However, there might be additional national requirements.
The following referenced documents are indispensable for the application 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 11979-1, Ophthalmic implants一Intraocular lenses一Part 1: Vocabulary
ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied一Part 1: General requirements
EN 980, Symbols for use in the labelling of medical devices
EN 1041, Information supplied by the manufacturer with medical devicess
For the purposes of this document, the terms and definitions given in ISO 11979-1 apply.
The package insert, in the form of a leaflet or similar, shall be included in the storage container in such a way that it can be consulted without damage to the sterile packaging. It shall contain at least the following information.
a) name or trade name and address of the manufacturer,
b) detailed description of the lens including material(s) used;
c) method of sterilization;
d) conditions of storage and transport (if appropriate);
e) instructions for the removal of the IOL from the primary container,
f) i instructions for use,
NOTE European Directive 93/42/EEC as amended by Directive 2007/47/EC requires date of issue or the latest revision of the instructions for use for medical devices sold in Europe.
g) indication(s) of the circumstances under which the IOL can be used;
h) contra-indication(s) of the circumstances under which the I0L should not be used;
i) complication(s) that may occur,
j) warning not to implant the IOL if the container which maintains sterility has been opened or damaged;
k) warning not to re-use the IOL;
l) warning not to re-stelie the lOL;
m) for multifocal and phakic intraocular lenses, a summary of the results of the clinical investigation, if any;BS EN ISO 11979-4 pdf download.