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YY 0804-2010: [YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods
YY 0804-2010
Transfer sets for pharmaceutical preparations.Requirements and test methods
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Liquid fluid transfer device requirements and test methods
(ISO 22413..2007, MOD)
2010-12-27 release
2012-06-01 implementation
State Food and Drug Administration issued
Preface
This standard is amended according to ISO 22413..2007 "Requirements and Test Methods for Liquid Translator and ISO 22413..2007/ADM1
Change the draft draft).
This standard by the National Medical Pipeline Standardization Technical Committee proposed and centralized.
The drafting of this standard. Shandong Province, medical equipment product quality inspection center, Shandong Weigao Group Medical polymer products limited
the company.
The main drafters of this standard. Song Jinzi, Yu Xin, Wang Jinhong, Zheng Xiaoye.
introduction
The liquid transfer device is a medical device that transfers the liquid from one container to another.
The transfer device is either composed of two punters or consists of a puncture device and a luer joint, which may be connected to each other with a different channel
Then, the transferor can have a cover.
Examples of different designs for liquid distillers.
a) two devices that are connected to each other (similar to the puncture device of the medicament container)
b) a metal cannula, both ends of which are either a) and b);
c) metal cannula, the center usually has a plastic fixed handle or handle;
d) two plastic punters connected by a handle or a certain length of the pipe (to provide a higher hydrostatic head)
e) the tip or outer side of the puncture device is the vent of the other end of the puncture device;
f) The puncture device also carries an air filter;
g) The perimeter of the puncture device has a cover to guide and position the connected container, and to protect the user from accidental injury
Harm and prevent the role of being touched;
h) the puncture device is combined with a luer conical joint;
i) The puncture device is combined with a luer conical joint and a particulate filter.
Liquid fluid transfer device requirements and test methods
1 Scope
This standard applies to disposable sterile liquid transfer devices.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 1962.1 Syringes, needles and other medical devices 6% Taper (Ruhr) Conical head Part 1. General requirements
(GB/T 1962.1-2001, ISO 594-1. 1986, IDT)
GB/T 1962.2 Syringes, Needles and Other Medical Devices 6% Taper (Ruhr) Cone Heads Part 2. Locking Cones
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB 8368 disposable infusion set gravity infusion type (GB 8368-2005, ISO 8536-4..2004, MOD)
GB 15811-2001 One-time use of sterile injectable needles (eqvISO 7864..1993)
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
(YY 0466.1-2009, ISO 15223-1..2007, IDT)
ISO 8362 injection container and its accessories
ISO 8536-2 Medical instruments - Part 2. Pharmacy corks
ISO 15747..2003 Intravenous injection of plastic containers
ISO 15759..2005 Hygienic pots - Plastic containers with flexible gaskets
3 design and marking
3.1 without the design of the cover transfer device
All the figures in this chapter (Figure 1 to Figure 4) give the design of each component. The illustrations are used to illustrate possible transfer design, and there may be other
design.
a) Single channel transferor Figure b) Single channel shifter combined with a Ruhr cone connector
Figure 1 single channel transfer device