Standards

YY/T 0654-2008 Automatic chemistry analyzer

This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marking and user manuals, packaging, transportation, and storage of fully automatic biochemical analyzers (hereinafter referred to as analyzers). This standard applies to analyzers that use liquid reagents to perform quantitative analysis on various samples.

Publish Date: 2008-04-25

YY/T 0655-2008 Dry chemistry analyzer

This standard specifies the technical requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage conditions for dry chemical analyzers. This standard applies to dry chemical analyzers (hereinafter referred to as analyzers) used in conjunction with solid-phase carrier reagents to conduct chemical tests on patient samples such as blood, urine, and cerebrospinal fluid in medical clinical settings. This standard does not apply to blood glucose analyzers, urine analyzers, blood gas analyzers, rapid myocardial infarction marker detectors, or other similar diagnostic analyzers.

Publish Date: 2008-04-25

YY/T 0657-2008 Medical centrifuge

This standard specifies the classification, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage requirements for medical centrifuges (hereinafter referred to as centrifuges). This standard applies to the design, production, and inspection of medical centrifuges. This standard does not apply to high-speed centrifuges (with a rotational speed exceeding 30,000 r/min).

Publish Date: 2008-04-25

YY/T 0658-2008 Semi-automated coagulation analyzer

This standard specifies the terms and definitions, classification and composition, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of semi-automatic coagulation analyzers. This standard applies to fully automatic coagulation analyzers used for analyzing coagulation, anticoagulation, fibrinolysis, and anti-fibrinolysis functions in blood. The standard specifies the technical requirements for instruments used to detect plasma prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT). Technical requirements for the detection of coagulation factors and D-dimer are not specified in this standard.

Publish Date: 2008-04-25

YY/T 0659-2008 Automated coagulation analyzer

This standard specifies the terms and definitions, classification and composition, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of fully automatic coagulation analyzers. This standard applies to fully automatic coagulation analyzers used for analyzing the coagulation and anticoagulation, fibrinolysis, and anti-fibrinolysis functions of blood. This standard stipulates the technical requirements for instruments used to detect plasma prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT). The technical requirements for detecting coagulation factors, D-dimer, etc. are not specified in this standard.

Publish Date: 2008-04-25

YY/T 0661-2008 Standard specification for virgin poly(L-lactic acid) resin for surgical implants

Publish Date: 2008-04-25

YY/T 0663-2008 Non active surgical implants—Particular requirements for cardiac and vascular implants—Specific requirements for arterial stents

This standard specifies the specific requirements for arterial stents, endovascular prostheses, and their release processes used to correct or compensate for arterial defects. For safety reasons, based on EN ISO 14630 and EN 12006-3, this standard sets forth specific requirements in terms of expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information. This standard applies to arterial stents and endovascular prostheses used in the aorta, the neck portion of intracranial arteries, coronary arteries, intracranial arteries, peripheral arteries, pulmonary arteries, ascending aorta, and visceral arteries. This standard also includes endovascular prostheses used to treat aneurysms, arterial stenosis, or other vascular abnormalities.

Publish Date: 2008-04-25

YY/T 0664-2008 Medical device software—Software life cycle processes

This standard specifies the requirements for the life cycle of medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for the life cycle process of medical device software.

Publish Date: 2008-04-25

YY/T 0127.11-2001 Dentistry—Preclinical evaluation of biocompatibility of medical devices used in dentistry—Part 2:Biological evaluation test method of dental materials—Pulp capping test

This standard specifies the test method for dental materials used in pulp capping. This standard is used to evaluate the biocompatibility of direct pulp capping materials with dental pulp. The operating procedures required for the clinical application of the materials are also included in this evaluation. Note: This test can be slightly modified to be used for pulpotomy testing.

Publish Date: 2001-11-09

YY/T 0268-2001 Dentistry—Preclinical evaluation of biocompatibility of medical devices used in dentistry—Part 1:Evaluation and test methods selection

This standard specifies the classification of medical devices used in the oral cavity and the selection of preclinical evaluation and test items for their biocompatibility.

Publish Date: 2001-11-09