UNI EN ISO 8612 : 2009
Current
The latest, up-to-date edition.
OPHTHALMIC INSTRUMENTS - TONOMETERS
19-11-2009
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Design compliance testing (certification)
4.3 Verification (instrument compliance)
4.4 Construction and function
5 Test methods
6 Accompanying documents
7 Additional information
8 Marking
Annex A (normative) - Reference tonometer and method for
determining reference IOP
Annex B (normative) - Design compliance testing
Ascertains minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP).
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 8612 : 2009 | Identical |
| UNE-EN ISO 8612:2010 | Identical |
| BS EN ISO 8612:2009 | Identical |
| EN ISO 8612:2009 | Identical |
| SN EN ISO 8612:2010 | Identical |
| NBN EN ISO 8612 : 2009 | Identical |
| NF EN ISO 8612 : 2010 | Identical |
| I.S. EN ISO 8612:2009 | Identical |
| ISO 8612:2009 | Identical |
| NS EN ISO 8612 : 2009 | Identical |
| DIN EN ISO 8612:2010-02 | Identical |
| ISO 15004-1:2006 | Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
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