YY/T 0690-2008Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (English PDF)

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 […]