What in ISO 14534: 2015 should be applied to contact lens care products?

Standard ISO 14534:2011 is a technical standard that specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. So, it is necessary to have this standard and see what are specific requirements regarding the contact lens care products. 

MDD 93/42/EEC specifies what needs to be done to show that every medical device is safe for performance. MDD asks the manufacturer to prepare the technical file which has in general following elements: description of the medical device (for example characteristics, content, type of the raw material, technical drawings, manufacturing process, clean room characteristics), clinical evaluation, post-market surveillance system, essential requirement checklist, declaration of conformity, stability testing, biocompatibility testing. To fulfill all of these requirements for contact lens care products you need to know what are the specific requirements for those products that are described in the ISO 14534:2011.