BS EN ISO 11979-8:2017

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Ophthalmic implants. Intraocular lenses – Fundamental requirements

Published By	Publication Date	Number of Pages
BSI	2017	14

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Categories: 11.040.70 - Ophthalmic equipment, BSI

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PDF Pages

PDF Title

National foreword

European foreword

Foreword

1 Scope
2 Normative references
3 Terms and definitions

4 Safety and performance
5 Optical and mechanical properties
6 Biocompatibility
7 Clinical evaluation
8 Manufacturing
9 Sterilization
9.1 General

9.2 Bacterial endotoxins
10 Packaging and shelf-life
11 Labelling and information
12 Documentation

Bibliography

Status	Confirmed
Title	Ophthalmic implants. Intraocular lenses – Fundamental requirements
Corrects	BS EN ISO 11979-8:2017
Replaces	BS EN ISO 11979-8:2015, BS EN ISO 11979-8:2009+A1:2011
Publisher	BSI
Committee	CH/172/7
Pages	14
Publication Date	2020-03-30
ISBN	978 0 539 13461 2
Standard Number	BS EN ISO 11979-8:2017
Identical National Standard Of	EN ISO 11979-8:2017, ISO 11979-8:2017
Descriptors	Labels, Packaging, Sterilization (hygiene), Clinical medicine, Mechanical properties of materials, Optical properties of materials, Performance, Equipment safety, Implants (surgical), Ophthalmic equipment, Optics, Eyes, Lenses, Ophthalmology
ICS Codes	11.040.70 - Ophthalmic equipment


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BS EN ISO 11979-8:2017

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