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BS EN ISO 14534:2015

Current

Current

Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-28-2015

US$238.62
Excluding Tax where applicable
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

Defines safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.

Committee
CH/172/9
DevelopmentNote
Supersedes 00/564763 DC (09/2002) Supersedes 09/30207531 DC. (05/2011) Supersedes BS 7208-17(1998). (08/2015)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

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.

US$238.62
Excluding Tax where applicable