BS EN ISO 8612:2009
Current
The latest, up-to-date edition.
Ophthalmic instruments. Tonometers
Hardcopy , PDF
English
30-11-2009
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
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
Gives minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP).
Committee |
CH/172/6
|
DevelopmentNote |
Supersedes 98/564611 DC. (05/2005) Supersedes 08/30173112 DC. (11/2009)
|
DocumentType |
Standard
|
Pages |
22
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
This International Standard, together with ISO15004-1, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP).
This International Standard takes precedence over ISO15004-1, if differences exist.
NOTE The true intraocular pressure is seldom directly measured since it would require invasion of the eye. Since the true IOP cannot be clinically measured, alternative methods are specified for determining a reference IOP (AnnexA and AnnexB).
Standards | Relationship |
NEN EN ISO 8612 : 2009 | Identical |
UNE-EN ISO 8612:2010 | Identical |
EN ISO 8612:2009 | Identical |
SN EN ISO 8612:2010 | Identical |
NBN EN ISO 8612 : 2009 | Identical |
NF EN ISO 8612 : 2010 | Identical |
UNI EN ISO 8612 : 2009 | 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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