Standard Swedish standard · SS-EN ISO 8612

Ophthalmic instruments - Tonometers (ISO 8612:2001)

Status: Withdrawn

· Replaced by: SS-EN ISO 8612:2009
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Standard Swedish standard · SS-EN ISO 8612

Ophthalmic instruments - Tonometers (ISO 8612:2001)
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Scope
This International Standard, together with ISO 15004, 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 the ISO 15004, if differences exist. NOTE 1 The true intraocular pressure is seldom directly measured since it would require invasion of the eye. Since the true IOP cannot be known, the instrument (annex A) and method (annex B) for determining a reference IOP are instead specified. NOTE 2 Clinical tonometers may employ different parameters or correlates in the indirect assessment of measured IOP. The manufacturer states the exact design parameters of the specific tonometer, and then, on the basis of design compliance testing as specified in 4.2, demonstrates that the specific design performs acceptably compared to the reference method. This process is referred to as certification. The manufacturer also demonstrates, by methods specified in 4.3, that individual manufactured instruments perform the same (within defined limits) as the test tonometer. This process is referred to as verification.

Subjects

Ophthalmic equipment (11.040.70)


Buy this standard

Standard Swedish standard · SS-EN ISO 8612

Ophthalmic instruments - Tonometers (ISO 8612:2001)
Subscribe on standards - Read more Dölj
Price: 875 SEK
standard ikon pdf

PDF

Price: 875 SEK
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Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-33075

Edition: 1

Approved: 11/1/2002

No of pages: 18

Replaced by: SS-EN ISO 8612:2009