jQuery Mobile Framework
Search Home >> Standards Wordwide >> Francaise de Normalisation(NF) >> NF EN ISO 15004-1-2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments.

NF EN ISO 15004-1-2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments.

Standard Number:  NF EN ISO 15004-1-2007
Title:  Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments.
Language:  French
Replaced by Standard:  NF EN ISO 15004-1-2009

Publication Date:  2007/8/1
Status:  Withdrawn
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment>>Ophthalmic equipment
Publisher:   Francaise de Normalisation(NF)
Price:  
Number of Pages:16  

Description:Specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. It is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.  
Catalog:Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Fundamental requirements (for non-active and active
ophthalmic instruments)
4.1 General
4.2 Design
4.3 Performance
4.4 Combination of different devices
4.5 Materials
4.6 Protection against contaminants
4.7 Scales and displays
4.8 Thermal hazards
4.9 Mechanical hazards
5 Environmental conditions (for non-active and active
ophthalmic instruments)
5.1 Environmental conditions of use
5.2 Storage conditions
5.3 Transport conditions
6 Particular requirements for active ophthalmic instruments
6.1 Electrical safety
6.2 Inapplicable clauses of IEC 60601-1:2005
6.3 Optical radiation hazard
7 Test methods
7.1 Ignitability
7.2 Surface temperatures
7.3 Environmental conditions
7.4 Checking electrical safety
8 Information supplied by the manufacturer
8.1 Accompanying documents
8.2 Marking
Annex A (informative) Product-related International Standards
for ophthalmic instruments
Annex ZA (informative) Relationship between this European Standard
and the Essential Requirements of EU
Directive 93/42/EEC on medical devices  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  987KB
Tile in English:  Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments.

Full Text Information

Related

Top 10

New 10

PC Version