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YY/T 0690-2008: Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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| YY/T 0690-2008 | English | 974 |
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Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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YY/T 0690-2008
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Basic data | Standard ID | YY/T 0690-2008 (YY/T0690-2008) | | Description (Translated English) | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.20 | | Word Count Estimation | 49,417 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Quoted Standard | GB 4793.1; GB/T 17626.2; GB/T 17626.3; GB/T 18268; GB/T 21415; YY/T 0287; YY/T 0316; ISO 15198; ISO 18113-1; ISO 18113-4; ISO 18113-5; IEC 60068-2-64-1993; IEC 61010-2-101-2002; EN 13532-2002; EN 13612; EN 13640; WHO Technical Report Series (NO.889; 1999) Appendix 3 is used to control oral anticoagulation treatment and plasma thromboplastin guidance terminology and definitions | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the vitamin K antagonist therapy in vitro measurement system to monitor its own specific requirements, including performance, quality assurance and user training as well as by the intended users in the real and simulated conditions of use for performance verification and validation procedures. This standard applies to individually monitor their own personal use of vitamin K antagonists, treatment and report the results of PT INR measurement system. This standard applies to oral anticoagulation in vitro monitoring systems manufacturers and their performance evaluation of the system is responsible for the other organizations (such as regulatory bodies and conformity assessment bodies). This standard does not apply to in vitro measurement system by a doctor or medical staff of vitamin K antagonist therapy anticoagulant dose assessment, provide all possible factors affecting system performance comprehensive evaluation, solve oral anticoagulation therapy medical problems. | YY/T 0690-2008: Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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Clinical laboratory testing and in vitro medical devices.Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ICS 11.100.20
C44
People's Republic of China pharmaceutical industry standards
YY/T 0690-2008/ISO 17593.2007
Clinical laboratory testing and in vitro medical devices
Oral anticoagulant therapy body self-test
Requirements Monitoring System
(ISO 17593.2007, IDT)
Posted 2008-10-17
2010-01-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 6 Design and Development
4.1 General requirements 6
4.2 Measurement Period 6
4.3 Security 6
4.4 Risk Management 6
Human Factors and Ergonomics 4.5 6
4.6 Quality Assurance and Risk Control 7
4.7 Metrological traceability of 7
Information provided by the manufacturer 8 5
5.1 General requirements 8
5.2 monitor oral anticoagulant flag 8
5.3 Use of oral anticoagulation monitoring system Description 8
5.4 Reagents and signs of controlled substances 9
5.5 Reagents and use of controlled substances a description 9
6 safety and reliability testing 10
6.1 General requirements 10
10 6.2 Protection against electric shock
6.3 against mechanical damage 10
6.4 Electromagnetic Compatibility 10
6.5 Heat 10
6.6 resistant to moisture and liquids 10
Release 6.7 anti-gas explosion and burst 10
6.8 Instrument assembly 11
6.9 Performance Test 11
6.10 resistance to mechanical shock, vibration and impact 11
6.11 Temperature exposure limits 11
6.12 exposed to humidity test program 11
6.13 Test reagent storage and use 12
7 Training and Education program 12
Training of medical staff 12 7.1
7.2 patients and other users of education 12
8 System Performance Verification 12
8.1 Overview 12
YY/T 0690-2008/ISO 17593.2007
Sources 13 8.2 Measurement Uncertainty
8.3 System Performance Verification Experiment 13
8.4 verify the precision of measurement 13
8.5 verify the accuracy of the system 16
8.6 minimum acceptable system accuracy 21
9 user performance evaluation 22
9.1 Overview 22
9.2 22 experimental sites
9.3 22 subjects
9.4 Instrument and material 23
9.5 User Proficiency Assessment 23
9.6 acceptance criteria and data evaluation 23
Evaluation 24 9.7 Description
Supplementary Appendix A (normative) electromagnetic compatibility requirements 25
Annex B (informative) Example 26 traceability chain
(Informative) calculation of sample size estimation bias Appendix C (Ref. [42]) 29
Annex D (informative) oral anticoagulation monitoring system prothrombin INR measurement uncertainty calculations Example 30
Annex E (informative) oral anticoagulation monitoring system for quality assurance elements 32
Annex F (informative) release oral anticoagulation monitoring system performance evaluation standard application form 33
References 39
YY/T 0690-2008/ISO 17593.2007
Foreword
This standard is identical with ISO 17593.2007 "Clinical laboratory testing and in vitro medical devices in vitro self-rated oral anticoagulant therapy monitoring
Measuring System Requirements. "
For ease of use, this standard made the following editorial changes.
The "international standard" be replaced by "this standard";
. "" Instead of as a decimal by decimal comma ",";
Delete international standards foreword.
Appendix A of this standard is a normative appendix, Appendix B, Appendix C, Appendix D, Annex E and Annex F is informative appendix.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing.
The main drafters of this standard. Yangzong Bing, Bi Chunlei, He Xueying.
YY/T 0690-2008/ISO 17593.2007
Introduction
Oral anticoagulant monitoring system is to measure the fresh, untreated human blood samples prothrombin time (hereinafter referred to as PT) in vitro diagnostic
medical instruments. PT is an indicator of blood clotting ability. Oral anticoagulant therapy for self-vitro diagnostic medical devices for artificial heart valves shift
Plant or suffering from ventricular fibrillation or deep vein thrombosis use. The patient's blood must be maintained sufficiently high concentration of anticoagulant drugs to reduce the formation of thrombin,
It should be low enough to avoid excessive bleeding. It allows users to use oral anticoagulation monitoring system for monitoring oral anticoagulation therapy and to take measures to control
System present in the blood anticoagulant level.
This standard applies to non-professional use of oral anticoagulation monitoring system. The main purpose is to determine a non-professional use of oral anti-
Coagulation medicine monitoring system to obtain acceptable performance requirements, as well as for manufacturers and other interested organizations of the system in line with the provisions of this standard
program of.
Based on the current level of technology of oral anticoagulation monitoring system performance standards have been established, indicating that provide significant benefits for patients [68]. This standard
The term "system accuracy" is given, the measurement of academic language commonly used in international standards (such as accuracy and measurement uncertainty) is not non-professional
Users familiar with. Affect the system accuracy of systematic bias and random factors (and Uncertainty opposite meaning) that is described by the non-expected
When professional users of oral anticoagulation monitoring system, the degree of consistency of results with a single correct INR values.
In the standards, assuming that the user can correct choice and receive the necessary training and equipment be properly maintained and operated and controlled process
Sequence can be performed according to the manufacturer's instructions. Also assumed the manufacturer can be expected to reduce the impact and foreseeable misuse of factors, including reasonable pre
The recommended maintenance, operation and control of the deviation procedures known to the user.
Particular requirements for self oral anticoagulation monitoring system, including manufacturers provide detailed content information, this standard was described.
For all in vitro diagnostic medical devices General requirements and contents are covered by other standards see reference (such as IEC 61010,
YY/T 0287/ISO 13485, YY/T 0316/ISO 14971 and ISO 18113). In addition, national legislation should apply.
This standard specifies the vitamin K antagonist therapy in vitro measurement systems to monitor their own specific requirements, from product development to the user application
It has been stipulated. Including product design and development, information, security, and reliability testing provided by the manufacturer, training and education process
Order, system performance validation, performance evaluation and other aspects of the user, the other relates to risk management standards YY/T 0316/ISO 14971 and quality management
Department standard YY/T 0287/ISO 13485. Therefore, this standard can be used as research and development, government regulation guiding standard, but can not be equated
Prior to market type test (registration inspection) standards.
YY/T 0690-2008/ISO 17593.2007
Clinical laboratory testing and in vitro medical devices
Oral anticoagulant therapy body self-test
Requirements Monitoring System
1 Scope
This standard specifies the vitamin K antagonist therapy in vitro measurement systems to monitor their own specific requirements, including performance, quality assurance and the use of
User training and performance by the intended user verification and validation in real conditions of use and simulation program.
This standard applies to the individual to monitor their own personal use vitamin K antagonist therapy and to report the results of PT INR measurement system.
This standard applies to oral anticoagulants in vitro monitoring system manufacturers and other organizations responsible for the performance evaluation of the system (such as regulators
Bodies and conformity assessment bodies).
This standard does not
--- Suitable for in vitro measurement system by a doctor or medical personnel to vitamin K antagonist anticoagulant therapy dose assessment;
--- Providing affect system performance comprehensive evaluation of all possible factors;
--- Oral anticoagulant therapy to solve the problem of medicine.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment Part 1. General requirements (GB 4793.1-
2007, IEC 61010-1.2001, IDT)
GB/T 17626.2 Electromagnetic compatibility Testing and measurement techniques - Electrostatic discharge immunity test (GB/T 17626.2-2006,
IEC 61000-4-2.2001, IDT)
GB/T 17626.3 electromagnetic compatibility test and measurement technology RFEMS test (GB/T 17626.3-
2006, IEC 61000-4-3.2002, IDT)
GB/T 18268 for measurement, control and laboratory use electrical equipment electromagnetic compatibility requirements (GB/T 18268-2000, IEC 61326-1.
1997, IDT)
GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability
Sex (GB/T 21415-2008, ISO 17511.2003, IDT)
YY/T 0287 medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485.2003, IDT)
YY/T 0316 Medical Devices Risk Management in Medical Devices (YY/T 0316-2003, ISO 14971.2000, IDT)
ISO 15198 Clinical Laboratory Medicine in vitro diagnostic medical device manufacturers quality control program for user authentication
ISO 18113-1. 1) Clinical laboratory testing and in vitro diagnostic medical systems manufacturer's information (label) - Part 1. surgery
Language, definitions and general requirements
ISO 18113-4. 1) Clinical laboratory testing and in vitro diagnostic medical systems manufacturer's information (label) - Part 4. Self
Measured using an in vitro diagnostic reagents
ISO 18113-5. 1) Clinical laboratory testing and in vitro diagnostic medical system manufacturers to provide information (labeling) - Part 5. Self
Measured in vitro diagnostic instruments
1) to be published.
YY/T 0690-2008/ISO 17593.2007
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