YY/T 1618-2018Single-use needles for human venous blood specimen collection (English PDF)

Foreword

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

Introduction

The single-use human venous blood sample collection needle is used together with the disposable vacuum venous blood sample collection container, and is collected from the human vein. Blood sample for blood analysis.

The traditional single-use human venous blood sample collection needle is invisible to return blood. In recent years, there is visible one-time use of the human body.

The blood sample collection needle appears in the clinic. Because of the special nature of the disposable venous blood sample collection needle for visible blood return, this standard does not have Give coverage. However, this standard recommends that manufacturers who use the venous blood sample collection needle for single-use blood return to actively use the phase in this standard. Terms and conditions.

Rubber sleeve resilience is an important performance indicator. The drafting unit developed a testing machine to test the rubber sleeve resilience and enter the data.

After collecting and comparing, the basic data of the rubber sleeve resilience was obtained. However, the performance of the test machine has yet to be improved, and the drift range of the test data There is a certain gap with the design requirements. In view of the current rubber sleeve resilience test method and test machine is not mature, this standard will test its side The performance of the method, the resilience of the test machine and the rubber sleeve is given in the form of an informative appendix. After the test method, test equipment and required parameters are determined, This standard is included as a normative clause when it is revised. Single use human venous blood sample collection needle

1 Scope

This standard specifies the venous puncture needle tube nominal outer diameter of 0.5mm~0.9mm disposable human venous blood sample collection needle (to The requirements of the "acquisition needle" are referred to below.

This standard does not apply to the requirement of visible blood return for one-time use of human venous blood sample collection needle, but encourages visible return blood disposable users.

Manufacturers of venous blood sample collection needles actively use the relevant provisions of this standard.

2 Normative references

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

GB/T 6682 Analytical laboratory water specifications and test methods

GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1

GB/T 14233.2-2005 Methods of test for infusions, blood trans

GB 15810 single use sterile syringe

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management

GB 18279.1 Sterilization of ethylene oxide for health care products - Part 1. Development, validation and routine control System requirements

GB 18280 Health care products sterilization confirmation and routine control requirements radiation sterilization

GB/T 18457 Stainless steel needle tube for medical devices

YY/T 0296 Disposable needle identification color mark

YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1 . General requirements The Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Classification and naming