YY/T 0617-2021Single-use containers for human capillary blood specimen collection (English PDF)

Foreword

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

This standard replaces YY/T 0617-2007 "Disposable Human Peripheral Blood Sample Collection Container". Compared with YY/T 0617-2007, The main technical changes are as follows.

--- Modified the scope of application of the standard, and clarified that the collection container for trace peripheral blood samples less than 20 µL is not within the scope of this standard (See Chapter 1, Chapter 1 of the.2007 edition);

--- Added normative references GB/T.19973.1-2015, YY/T 0466.1 (see Chapter 2);

--- Modified the terms and definitions, deleted the gravimetric analysis method (see 3.7 of the.2007 edition), the nominal filling line (see.2007 edition)

Version 3.9), adding main color (see 3.8), filling volume (see 3.10), add-ons (see 3.12), relative centrifugal force (see 3.16);

--- Increased the requirements for the tube body (see 4.1);

--- Delete the requirements for the capacity part (5.2, 5.3 of the.2007 edition);

--- Added relevant requirements for transportation (see 6.5);

--- Increased requirements for peripheral blood sample collection containers for coagulation tests (see 9.2);

--- Revised the requirements for the recommended color scale (see Appendix D, Table 1 of the.2007 edition).

1 Scope

This standard specifies the requirements and test methods for disposable human peripheral blood sample collection containers (peripheral blood sample collection containers).

This standard applies to peripheral blood sample collection containers that are expected to be single-use and with a blood collection volume of 20 µL to 1000 µL.

This standard does not apply to venous blood sample collection containers, arterial blood sample collectors and micro blood collection pipettes.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 6682 Analysis Laboratory Water Specifications and Test Methods GB/T.19973.1-2015 Microbiological Methods for Sterilization of Medical Devices Part 1: Determination of Total Microorganisms on Products

YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1: General Requirements

3 Terms and Definitions

The following terms and definitions apply to this document.