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BS EN ISO 8612:2009

Current

Current

The latest, up-to-date edition.

Ophthalmic instruments. Tonometers

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2009

€165.94
Excluding VAT

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).

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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