YY/T 0501-2014Urine dry chemistry analysis control material (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

Instead of the standard YY/T 0501-2004 "urinalysis quality control material", compared with the YY/T 0501-2004, the main technical change as follows.

--- Standard name "urinalysis control material" to "quality control material for chemical analysis of urine dry";

--- Require content "working conditions" is adjusted to the test method;

--- Loading capacity requirements "liquid quality control material loading amount of the maximum negative deviation of 2%" to "loading amount should not be less than the nominal value";

--- Increased requirements "set nominal value", which increases the content "except gravity, pH, the nominal value of the positive control were at least high In a negative order of magnitude or two settings ";

--- "Accuracy" to "QC Test value", the contents of "bilirubin, urobilinogen, ketones, blood (occult blood, hemoglobin), nitrous acid Negative Control salts, leukocytes, glucose and albumin items shall not be detected positive results can not be measured by the positive control was negative Results "was changed to" Test results shall meet the requirements of quality control material provisions ";

--- "Within run precision" to "uniformity", the corresponding content was revised to "projects of the test results should be consistent level 100% ";

--- "Stability during storage" to "stable";

--- "After opening shelf stability" to "Kaifeng (dissolved) after stability", the corresponding content was revised to "take or dissolved after Kaifeng Quality control material, under specified conditions of storage to stabilize the end of the test, the test results should meet the requirements of 3.4.2. ";

--- "Under storage conditions stability" to "lifetime stability", the respective content modifications measure as "quality control was taken to after the limitation period Test, test results should meet the requirements of 3.4.2,3.5. " Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.

1 Scope

This standard specifies requirements for dry chemical analysis of urine quality control material, test methods, marking, labeling and instructions for use, packaging, transport and storage Memory and so on.

This standard applies to urine, dry chemical analysis quality control material (hereinafter referred to as quality control material).

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs

3 Requirements