JJF 1644-2017 English PDF

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JJF 1644-2017: The Production of Reference Materials for Clinical Enzymology
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JJF 1644-2017	349	Add to Cart	3 days	The Production of Reference Materials for Clinical Enzymology	Valid

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Basic data

Standard ID: JJF 1644-2017 (JJF1644-2017)
Description (Translated English): The Production of Reference Materials for Clinical Enzymology
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A66
Word Count Estimation: 15,129
Date of Issue: 2017-09-26
Date of Implementation: 2017-12-26
Regulation (derived from): General Administration of State Quality Inspection Announcement 2017 No. 78
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine

JJF 1644-2017: The Production of Reference Materials for Clinical Enzymology

---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.
(Clinical specification for the development of clinical enzymes) People's Republic of China National Measurement Specifications Development of Clinical Enzymatic Reference Materials The Production of Reference Materials for ClinicalEnzymology 2017-09-26 Posted 2017-12-26 Implementation General Administration of Quality Supervision, Inspection and Quarantine released Development of Clinical Enzymatic Reference Materials The Production of Reference Materials Focal point. National Standard Material Measurement Technical Committee The main drafting unit. China National Accreditation Center for Conformity Assessment Beijing Aerospace General Hospital China Institute of Metrology Participate in the drafting unit. National Health and Family Planning Commission clinical testing center Nantong University Hospital This specification entrusts the national standard material measurement technical committee to be responsible for explaining The main drafters of this specification. Lu Jing (China National Accreditation Service for Conformity Assessment) Chen Baorong (Beijing Aerospace General Hospital) Wu Liqing (China Institute of Metrology) Participate in the drafters. Wang Huimin (Nantong University Hospital) Zhang Chuanbao (National Health and Family Planning Commission Clinical Laboratory Center) Sun Huiying (Beijing Aerospace General Hospital) Shi Guanghua (China National Accreditation Service for Conformity Assessment)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 References (1) 3 Terms and definitions (1) 3.1 Enzymes (1) 3.2 Enzyme Activity (1) 3.3 enzyme activity units (2) 3.4 Enzyme catalytic activity concentration (2) 4 development planning (2) 4.1 Requirements and expected performance requirements (2) 4.2 Feasibility Assessment (2) 5 Preparation (2) 5.1 raw material requirements (2) 5.2 Preparation Requirements (3) 6 Uniformity and stability assessment (3) 6.1 Uniformity Assessment (3) 6.2 Stability Assessment (3) 7 Interchangeability Assessment (4) 7.1 Evaluation Principles (4) 7.2 Evaluation methods (4) 8 setting (4) 8.1 Setting Principles (4) 8.2 valuation program design (4) 8.3 Quality Control (5) 8.4 Data Evaluation (5) 8.5 Collaborative Setting Report (5) 8.6 Standard Material Assignment and Uncertainty Assessment (5) 9 research reports and certificates (6) 9.1 Development Report (6) 9.2 Certificate (6) 10 Packaging, storage and maintenance (6) 10.1 Packaging and labeling (6) 10.2 Storage (6) 10.3 Maintenance (6) Appendix A clinical enzymatic reference material interchangeability evaluation example (7)

Introduction

Clinical enzyme standard material (hereinafter referred to as enzyme standard material) as a measure of enzyme activity traceability and delivery of vector Widely used in medical testing activities, the quality of standard substances is of great importance to ensure the effectiveness of the above activities. The main purpose of this specification is to regulate the development of enzyme standard material for medical testing and other activities to meet the quality requirements Of the standard material. JJF 1343 "General Principles of Quantitative Determination of Reference Principles and Statistical Principles" for the development of enzyme standards provided Use guidelines. This specification reference to GB/T 21919 "test medical reference measurement laboratory requirements", WS/T 419 "Assignment of Enzyme Activity Concentrations in Reference Materials", WS/T 356 "Guidelines for the Evaluation of Matrix Effects and Interoperability" CLSIEP30-A "Characteristics and Conditions of Interchangeability of Reference Materials for Medical Testing", CLSIEP14-A3 "Processed Sample interchangeability assessment "and other domestic and foreign normative technical documents, based on the JJF 1343 applied to enzyme standards Quality research carried out a description and refinement. The corresponding Chinese for "ReferenceMaterial (RM)" includes "standard." Quality "," reference substance "or" standard sample ", the standard use of" standard substance. " This specification is first released. Development of Clinical Enzymatic Reference Materials

1 Scope

This standard specifies the development of clinical enzyme standard material (hereinafter referred to as enzyme standard material) planning, preparation, uniform Sexual Assessment, Stability Assessment, Interchangeability Assessment, Rating, Uncertainty Assessment, Development Reports and Certificates, Packaging and Storage Deposit and other requirements, apply to guide the clinical enzymology level, two certified reference material development, but also for other types of standards Material and clinical enzymology measurement quality control samples for reference.

2 reference documents

JJF 1001 common measurement terms and definitions JJF 1005 standard terms and definitions commonly used JJF 1265 Biometric terms and definitions General Principles and Statistical Principles of JJF 1343 Standard Substance Setting JJF 1059.1 Evaluation and Expression of Measurement Uncertainty JJF 1186 standard substance certification certificate and label content writing rules JJF 1218 standard substance development report writing rules GB/T 19703 In Vitro Diagnostic Medical Devices Measurement of Biomass Source Samples Description of Reference Materials (ISO 15194, IDT) Assignment of enzyme activity concentrations in reference material Guidance on evaluation of matrix effects and interoperability CLSIEP30-A Medical Laboratory Standardization and Identification of Interchangeable Reference Materials (Characterizationand qualificationofcommutablereferencematerialsforlaboratorymedicine) The CLSIEP14-A3 sample after processing evaluation of interchangeability (Evaluationofcommutabilityofpro- cessedsamples) For dated references, only the dated version applies to this specification. All references to the date without reference The latest version (including all amendments) applies to this specification.

3 Terms and definitions

JJF 1001 "Common measurement terms and definitions", JJF 1005 "common terms and definitions of standard substances", JJF 1265 "Biometrics terms and definitions" in the terms and the following terms apply to this specification. 3.1 enzyme enzyme A protein, RNA, or complex thereof that catalyzes a specific chemical reaction. [JJF 12654.8] Note. By artificial synthesis so-called artificial enzyme also has enzyme-like catalytic activity, including synthetic DNA Other biological macromolecules. 3.2 Enzyme activity enzymaticactivity The ability of enzymes to catalyze specific chemical reactions. Available units of enzyme activity that. [JJF 12654.9] ......

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