Name: EN ISO 8612:2009
Brand: CEN

Ophthalmic instruments - Tonometers (ISO 8612:2009)

Published date

10-01-2009

Publisher

Comite Europeen de Normalisation

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

ISO 8612:2009, together with ISO 15004-1, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP).ISO 8612:2009 takes precedence over ISO 15004-1, if differences exist.

Committee	CEN/TC 170
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
DIN EN ISO 8612:2010-02	Identical
I.S. EN ISO 8612:2009	Identical
ISO 8612:2009	Identical
SS-EN ISO 8612:2009	Identical
PN EN ISO 8612 : 2010	Identical
NS EN ISO 8612 : 2009	Identical
SN EN ISO 8612:2001	Identical
UNI EN ISO 8612 : 2009	Identical
NEN EN ISO 8612 : 2009	Identical
UNE-EN ISO 8612:2010	Identical
DIN EN ISO 8612 E : 2010	Identical
BS EN ISO 8612:2009	Identical
SN EN ISO 8612:2010	Identical
NBN EN ISO 8612 : 2009	Identical
NF EN ISO 8612 : 2010	Identical

ISO 15004:1997	Ophthalmic instruments Fundamental requirements and test methods
IEC 60601-1-1:2000	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems