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Impression tonometers
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YY 1036-2004
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Basic data Standard ID | YY 1036-2004 (YY1036-2004) | Description (Translated English) | Impression tonometers | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C40 | Classification of International Standard | 11.040.55 | Word Count Estimation | 10,144 | Date of Issue | 2004-03-23 | Date of Implementation | 2005-01-01 | Older Standard (superseded by this standard) | YY 91036-1999 | Adopted Standard | ISO/TR 8612-1997, NEQ | Regulation (derived from) | SFDA [2004] No. 86 | Summary | This standard specifies the indentation tonometer classification, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. This standard applies to indentation tonometer (hereinafter referred to as tonometer), the product is used for the measurement of intraocular pressure. |
YY 1036-2004: Impression tonometers---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Impression tonometers
ICS 11.040.55
C40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 91036-1999
Indented tonometer
Released on.2004-03-23
2005-01-01 implementation
State Food and Drug Administration released
Foreword
This standard is revised on the basis of YY 91036-1999 "indentation tonometer", this revision refers to ISO /T R8612.1997
"Ophthalmic instrument mechanical indentation tonometer", as the main basis for the revision, and according to the current situation in China, the relevant technical differences have been made appropriate
The amendments are mainly as follows.
ISO /T R8612.1997 specifies the assembly quality requirements for hammer bows, hands, needles and fixed weights. When the pointer position is "5",
The mass error of 5.5g is ±0.15g; this standard is ±0.20g.
The ISO /T R8612.1997 specifies that the inclination does not exceed 25°; this standard does not exceed 28°.
Appendix A of this standard is a normative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Optics and Instruments.
This standard was drafted. Suzhou Liuliu Vision Technology Co., Ltd.
The main drafters of this standard. Hang Yuyuan.
From the date of implementation of this standard, YY 91036-1999 "indentation tonometer" is abolished.
Indented tonometer
1 Scope
This standard specifies the classification, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and
Storage.
This standard applies to indentation tonometer (hereinafter referred to as tonometer), which is used for measuring intraocular pressure.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all
Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study
Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard.
GB/T 1220-1992 stainless steel rod
GB/T 2828-1997 Batch-by-batch inspection sampling procedure and sampling table (for continuous batch inspection)
GB/T 2829-2002 Periodic inspection count sampling procedures and tables (applicable to the inspection of process stability)
GB 9969.1-1998 General instructions for the use of industrial products
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
It is an instrument for indirectly determining the intraocular pressure by measuring the indentation depth of the cornea according to a certain quality needle, on the tonometer scale
Each cell is equivalent to the indentation depth of the cornea of 0.05 mm, and the intraocular pressure value is obtained according to the indentation depth and the weight of the weight.
3.2
The needle deforms the cornea to a quasi-equilibrium between internal and external pressure, and then the depression depth is measured.
4 Product Categories
4.1 The type of tonometer is a mechanical depression type.
4.2 Normal working conditions.
a) ambient temperature 10 ° C ~ 40 ° C;
b) relative temperature 30% to 75%;
c) The atmospheric pressure ranges from 700 hPa to 1060 hPa.
4.3 The basic dimensions of the tonometer should be in accordance with Table 1.
Table 1 Basic dimensions are in millimeters
Part name basic size tolerance
The radius of curvature of the bottom of the foot tube is 15 ± 0.25
The diameter of the bottom surface of the foot tube is 10.1 ± 0.20
The bottom surface of the pressure pin has a radius of curvature of 15 ± 0.75
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