YY/T 1193-2011Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay) (English PDF)

4.7 Repeatability

Use the samples with at least 2 concentration levels. Respectively repeat the detection for 10 times. The coefficient of variation (CV) shall not be more than 8.0% (instrument-automatic operation method) or not more than 12.0% (manual operation method).

4.8 Within-batch difference

Use 3 batches of kits to detect the same sample. The coefficient of variation (CV) among the 3 kits shall not be more than 15.0%.

4.9 Stability

The following methods can be used for verification.

a) Stability within the validity. The manufacturing enterprise shall specify the validity of the kit. Take the kit that has been expired to detect the accuracy, minimum detection limit, linearity and repeatability. It shall meet the requirements of 4.3, 4.4, 4.6 and 4.7;

b) Thermal stability test. The kit within the period of validity is placed at 37°C for 3d.

Test the accuracy, minimum detection limit, linearity and repeatability. It shall meet the requirements of 4.3, 4.4, 4.6 and 4.7.

Note 1. Thermal stability test cannot be used to derive the validity of products, unless it uses the derivation formula that is established and based on a large number of stability study data;

Note 2. Any arbitrary combination of a) and b) can be selected according to the product characteristics, but the selected method shall be capable of verifying the stability of the product, so as to ensure that the performance of the product can comply with the standard requirements within valid period.

5.1 Appearance

Use the corrected-visual-acuity to visually inspect, under the natural light. It shall meet the requirements of 4.1.

5.2 Traceability

Traceability information provided by the manufacturing enterprise shall meet the requirements of 4.2.

e) Product batch number;

f) Expiration date; g) Storage conditions.

6.2 Marks and labels of each component package of kit

It shall contain at least the following contents.

a) Product names and packaging specifications;

b) Name or trademarks of manufacturers;

c) Product batch number;

d) Expiration date; e) Storage conditions.

6.3 Instructions of kit

It shall include at least the following contents.

a) Product name;

b) Packaging specifications;

c) Intended use;

d) Detection principle;

e) Main compositions;

f) Storage conditions and expiration date;

g) Applicable instrument;

h) Sample requirement;

i) Detection method;

j) Reference value (Reference range);

k) Explanation of the detection result;

l) The limitations of detection methods;

m) Product performance index;

Bibliography 1. YY/T 0316-2008 Medical devices - Application of risk management to medical devices (ISO 14971. 2007, IDT)

2. YY/T 0466.1-2009 Devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223.1-2009, IDT)

4. GB/T 9969-2008 General principles for preparation of instructions for use of industrial products […]