Shandong Yiguang Medical Instruments co.

,ltd
Address:Sanjiu science-technology industrial park,chiping
county,252100 Shandong,China
Tel: 0086-635-4283658 fax:0086-635-6197460

Executive summary
of the transfusion Set for single use
 Shandong Yiguang Medical Instruments co.,ltd
Address:Sanjiu science-technology industrial park,chiping
county,252100 Shandong,China
Tel: 0086-635-4283658 fax:0086-635-6197460
1. Brief introduction on transfusion set for single use

1.1 General

Shandong Yiguang Medical Instrument Co., Ltd is manufacturer of disposable medical products.
The products of transfusion set are inspected by China Nation Medical Macromolecule Inspection
Centre as qualified products. The clinical use carried out by a lot of large-scale domestic hospitals
is proved to be good effects. The main feature is reasonable structure, convenient use, good quality,
strict sterilization and that the safety of patients can be assured effectively. The products are sold
well not only in 20 domestic provinces or cities but also are sold to more than 30 countries
including Holland, Italy, Macedonia, Turkey, Finland, Croatia, Romania, Poland, The Czech
Republic, Ukraine, Chile, Peru, Ecuador, Venezuela, Argentina, Iran, Jordan, Yemen, Iraq, Saudi
Arabia, Amman, Uzbekistan, Kazakhstan, Philippines, Thailand, Singapore and so on.
With high quality and good service, the company has a good reputation from the home and broad.

1.2 Product classification

According to Annex IX of MDD, the transfusion sets for single use manufactured by our company
are surgically invasive, non-active, intended for transfusion or transfusion into body and
short-term use of medical devices. They comply with the rule 7 of Annex IX of MDD, so they
belong to the kinds of IIa.

1.3 Structure

Products Descriptions
transfusion components parameter Raw material
set
Spike cover / PP/PE
Plastic spike With air-vent ABS
Drip tube 20drops/ml ABS
Drip chamber / PVC
Blood Filter / NYLON
Predominant 135/150/165/180/200CM PVC
tube
Roller clamp / PE/ABS
Injection site Latex Bulb/Y-site/Y-site needle free Latex/PP+LATEX
connector Luer lock/luer slip PP/ABS
Hypodermic 18-27G SUS304
 Shandong Yiguang Medical Instruments co.,ltd
Address:Sanjiu science-technology industrial park,chiping
county,252100 Shandong,China
Tel: 0086-635-4283658 fax:0086-635-6197460
needle stainless+PP

1.4 Conformity assessment route:

According to EU regulation MDD 93/42/EEC Annex Ⅴ

1.5 UMDNS CODE:

The UMDNS CODE of the transfusion Set is 17984.

1.6 Purpose

The transfusion sets, whose structure is accordance with technical demands of ISO8536-2010 are
assembled under 100,000-class purified conditions of constant temperature, constant pressure,
sterile and no dust particles, then are sterilized according to EN550 standard. The biological,
chemical and physical property of products attains the specified requirements completely. As the
essential instruments for the transfusion of human body, it can stop the spread of diseased source
and cross infection of all kinds of bacteria, virus, it plays an important action on improving the
level of medical treatment and public health and protecting the health of people.

1.7 Caution

1.4.1 After the products are sterilized with E.O. gas, use within valid time according to the valid
date on the primary bag.
1.4.2 Open and use immediately. Discard after use. Don’t use if package is damaged or open.
1.4.3 When the transfusion set is used, expel the air at first, then inject accordance with the old
routine, adjust the flow rate by using the flow regulator.
 Shandong Yiguang Medical Instruments Co. Ltd
Sanjiu Science and Technology Industrial park, Chiping County, Shandong Province,252100
China
Tel: (0635)4289698 Fax:（0635)6197460

CERTIFICATE OF PRODUCT COMPONENT

TRANSFUSION SET FOR SINGLE USE

MAIN STRUCTURE：SPIKE PROTECTOR, SPIKE, AIR VENTED WITH CAP, DRIPPING

CHAMBER, FLUID FILTER, TUBE, FLOW REGULATOR , INJECTION PORT, CONNECTOR,
NEEDLE

SPIKE PROTECTOR MEDICAL GRADE HIGH TRANSPARENT

POLYPROPYLENE
SPIKE ABS
AIR VENTED
PVC

M DRIPPING CHAMBER
PVC
A
T BLOOD FILTER
ABS & NYLON
E
R TUBE PVC
I FLOW REGULATOR
ABS OR PE OR PP
A
L INJECTION PORT LATEX OR ABS

CONNECTOR ABS OR PP

NEEDLE AISI STAINLESS STEEL, POLYPROPYLENE

AISI
AIR VENTED,
TUBE LENGTH,
OPTION
FLUID FILTER,
INJECTION PORT，
PACKING

PE BAG,
INDIVIDUAL
BLISTER BAG
MIDDLE PE BAG

OUTER CARTON