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JJG 1089-2013 English PDF

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JJG 1089-2013: Verification Regulation of Osmometers
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
JJG 1089-2013	English	299	Add to Cart	3 days [Need to translate]	Verification Regulation of Osmometers	Valid	JJG 1089-2013

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Standard similar to JJG 1089-2013

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Basic data

Standard ID	JJG 1089-2013 (JJG1089-2013)
Description (Translated English)	Verification Regulation of Osmometers
Sector / Industry	Metrology & Measurement Industry Standard
Classification of Chinese Standard	A50
Classification of International Standard	17.020
Word Count Estimation	13,148
Quoted Standard	People's Republic of China Pharmacopoeia (2010 edition) Appendix VH osmolality assay
Regulation (derived from)	AQSIQ Notice No. 154 of 2013
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine
Summary	This standard applies to: the use of freezing point depression principle osmolarity tester (hereinafter referred to as the instrument) initial verification, testing and use of subsequent checks.

JJG 1089-2013: Verification Regulation of Osmometers

---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.
Verification Regulation of Osmometers State verification procedures People's Republic of China Osmolality analyzer Osmometers Issued on. 2013-10-25 2014-01-25 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Osmolality analyzer test procedures VerificationReg Focal point. the National Technical Committee on Clinical Measurement The main drafting units. China Institute of Metrology Participated in the drafting unit. Institute of Measurement and Detection Guangzhou Tianjin Tianhe Medical Instrument Co., Ltd. The measurement procedure commissioned the National Technical Committee responsible for the interpretation of clinical medicine The main drafters of this procedure. Qi Xin (China Institute of Metrology) Repair Hongyu (China Institute of Metrology) Drafters participate. Huliang Yong (Guangzhou Institute of Measurement and Detection) Yan Fu (Tianjin Tianhe Medical Instrument Co., Ltd.)

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 terminology and units of measurement (1) 4 Overview (1) 5 metering performance requirements (1) 6 General Requirements (2) 6.1 Appearance (2) 6.2 boot check (2) 7 control of measuring instruments (2) 7.1 verification Conditions (2) 7.2 Verification Project (2) 7.3 Verification Methods (3) 7.4 test results processing (3) 7.5 test cycle (3) Appendix A test original record format (4) Appendix B test certificates/test results in the notice page format (5)

Introduction

JJF1002-2010 "national verification procedures write rules", JJF1001-2011 "common terminology and measurement The definition of "together constitute the support of the protocol development of the basic family of specifications. This procedure of "People's Republic of China Pharmacopoeia" (2010 edition) of the osmolarity of the analyzer requirements As the basis for the development. This procedure was first formulated. Osmolality analyzer test procedures

1 Scope

The order applies to the use of the principle of freezing point depression osmolality analyzer (hereinafter referred to as equipment) for the first time Test, test and subsequent use of checks. 2. References People's Republic of China Pharmacopoeia (2010 edition) Appendix VH osmolarity assay For dated references, only the dated edition applies to this procedure; undated reference documents Member, the latest edition (including any amendments) applies to this procedure.

3 terminology and units of measurement

3.1 capacity osmolarity Osmolarity Per liter of solution refers to the number of moles of solute in the permeate, Osmol·L-1 units or mOsmol·L-1, 1Osmol·L-1 = 1000mOsmol·L-1. 3.2 wt osmolality Osmolality Refers to the solute per kilogram of solvent penetration mole number of units Osmol · kg-1 or mOsmol · kg-1, 1Osmol · kg-1 = 1000mOsmol · kg-1.

4 Overview

The instrument works by indirectly measuring the osmolarity of the solution using the freezing point depression. The temperature measurement Probe immersed in the center of the solution, and fell to the instrument cooling slots. Start the cooling system, when the temperature dropped below freezing solution The next, the instrument uses an oscillator (or metal probe) induced by freezing the solution, automatically record the temperature of the freezing point depression. instrument Data processing system after the temperature of the freezing point depression of the data processed by the terms of osmolality. Instrument usually consists of refrigeration systems, temperature measurement system, temperature control system, data processing system and a display system and other parts composition.

5 metering performance requirements

Instrumental performance indicators are shown in Table 1. Table 1 test and measurement of project performance indicators No. test items measured performance indicators

1 Indication error

Not more than 400mOsmol · kg-1 when no more than ± 6mOsmol · kg-1 Concentrations greater than 400mOsmol · kg-1 when no more than ± 1.5% 2 Repeatability ≤2mOsmol · kg-1 3 Stability ≤2mOsmol · kg-1

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