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ILNAS-EN ISO 15004:1997
Edition
12/1997
Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
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Abstract
This International Standard specifies Fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This International Standard 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 eyes. This International Standard takes precedence over the corresponding requirements of the other general standards cited in clause 2, if differences exist. This International Standard does not apply to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
Status
| Standard - Superseded |
Origin
| Technical Committee : |
| CEN/TC 170 : Ophthalmic optics |
Directives
|
93/42/EEC : Medical devices
|
Implementation
| start of the vote on the project | 07/12/1995 | date of ratification (dor) | 04/12/1997 | |||
| end of the vote on the project | 07/05/1996 | date of anouncement (doa) | 31/03/1998 | |||
| start of the vote on the final project | 21/08/1997 | date of publication (dop) | 30/06/1998 | |||
| end of the vote on the final project | date of withdrawal (dow) | 30/06/1998 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
30/01/1998 |
| Reference |
Relations
| Evolutions |
| ILNAS-EN ISO 15004-2:2007 |
| ILNAS-EN ISO 15004-1:2006 |
| Relations to international standards |
| ISO/CD 15004 |
| ISO 15004:1997 |
International Classification for Standards (ICS codes) :
| 11.040.70 : Ophthalmic equipment |
