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EN ISO 14534:2015

Current

Current

The latest, up-to-date edition.

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

Published date

28-01-2015

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Summarise this standard

Foreword
Introduction
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
11 Packaging
12 Shelf-life and discard date
13 Labelling and information supplied by
   the manufacturer
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical Devices

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.

Committee
CEN/TC 170
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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