YY 1036-2004 English PDFUS$399.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 1036-2004: Impression tonometers Status: Obsolete
Basic dataStandard 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11.040.55 Word Count Estimation: 10,144 Date of Issue: 2004-03-23 Date of Implementation: 2005-01-01 Older Standard (superseded by this standard): YY 91036-1999 Adopted Standard: ISO/TR 8612-1997, NEQ Regulation (derived from): SFDA [2004] No. 86 Summary: This standard specifies the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 ForewordThis 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 tonometer1 ScopeThis 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 referencesThe 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 products3 Terms and definitionsThe 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 Categories4.1 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 ...... |
