ISO 14534:2011
Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.
ISO 14534:2011 does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.
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1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Risk assessment
6 Design
7 Materials
8 Clinical evaluation
9 Manufacturing
10 Microbiological requirements
10.1 Contact lenses
10.1.1 Lenses delivered sterile
10.1.2 Lenses delivered non-sterile
10.1.3 Trial lenses
10.2 Contact lens care products
10.3 Other accessories for contact lenses
11 Packaging
12 Shelf-life and discard date
13 Labelling and information supplied by the manufacturer
13.1 General
13.2 Additional information requirements for contact lenses
13.3 Additional information requirements for contact lens care products
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1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Risk assessment
6 Design
7 Materials
8 Clinical evaluation
9 Manufacturing
10 Microbiological requirements
10.1 Contact lenses
10.1.1 Lenses delivered sterile
10.1.2 Lenses delivered non-sterile
10.1.3 Trial lenses
10.2 Contact lens care products
10.3 Other accessories for contact lenses
11 Packaging
12 Shelf-life and discard date
13 Labelling and information supplied by the manufacturer
13.1 General
13.2 Additional information requirements for contact lenses
13.3 Additional information requirements for contact lens care products