WS/T 224-2018 in English

VALID

Performance verification of vacuum tubes for venous blood specimen

Issued on:2018-04-27
Implemented on:2018-11-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $320.00
$311.00

Standard No:	WS/T 224-2018
Document status:	VALID
Title in English:	Performance verification of vacuum tubes for venous blood specimen
Title in Chinese:	真空采血管的性能验证
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-04-27
Implemented on:	2018-11-01
Superseding:	WS/T 224-2002 Evacuated tubes and additives for blood speciment collection
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Keywords:	edition standard name vacuum blood collection tubes blood collection tubes performance verification full verification joint verification vacuum tubes
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本标准规定了真空采血管性能要求及验证方法。
本标准适用于临床实验室在正式使用新采血管前对其进行性能验证。对正在使用的采血管的检测结果有疑问、查找原因可能与采血管相关时，也可采用本标准对采血管进行性能验证。

Introduction

Core Changes of the Standard Revision

Comparison Dimensions	2002 Edition	2018 Edition
Standard Name	Vacuum Blood Collection Tubes and Their Additives	Performance Verification of Vacuum Blood Collection Tubes
Technical Indicators	Mainly Manufacturer Testing	Four New Clinical Evaluation Indicators
Centrifugal Force Requirements	Value Not Cleared	Increased to 3000g

Key Performance Verification Points

1. Pumping Volume Verification

Use the gravimetric analysis method, and the relative bias is required to be within ±10%. Verification steps:

Use a 20G standard blood collection needle to collect water
Weigh 30 samples and calculate the average value
Determine according to the formula RD=(DV-NLC)/NLC×100%

2. Tube Strength Test

The new standard increases the centrifugal force requirement from ~~unclear in the original standard~~ to 3000g centrifugation for 10 minutes. Please note the following during verification:

Sample volume: 30 tubes filled with water to the scale line
A centrifugal radius of 17cm corresponds to 4000r/min
Observe tube leakage

Clinical Evaluation Innovation Indicators

Serum Separation Tube Verification Case

Testing on 40 samples revealed the following:

Serum separation tube

Hematology routine tube

Implementation Suggestions

Verification Process Optimization

Batch Management: New batches of blood collection tubes require full verification
Joint Verification: 4.4-4.6 indicators can be tested simultaneously
Data Retention: Original weighing records should be kept for at least 2 years

Troubleshooting

When fibrin adhesion occurs, check:

Whether the number of shakes after blood collection meets the requirements
Whether the standing time reaches 30 minutes
Whether the centrifugation parameters are accurate

More samples: GB 18306-2015 NB/T 47013.2-2015 DL/T 368-2010

Sample only — not a preview of WS/T 224-2018

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