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YY 0326.3-2005 English PDF (YY0326.3-2005)

YY 0326.3-2005 English PDF (YY0326.3-2005)

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YY 0326.3-2005: Plasmapheresis centrifuge apparatus for single use - Part 3: Containers for plasma

This Part of YY 0326 specifies the requirements for containers for plasma used together with hemostix specified in YY 0328, plasma tubing specified in YY 0326.2 and plasma centrifuge bowl specified in YY 0326.1. The plasma collected and stored in containers for plasma specified in this Part is used to prepare blood products. It cannot be used for clinical blood transfusion.
YY 0326.3-2005
YY
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
ICS 11.040.20
C 31
Plasmapheresis centrifuge apparatus for single
use - Part 3. Containers for plasma
Issued by. China Food and Drug Administration
ISSUED ON. DECEMBER 07, 2005
IMPLEMENTED ON. DECEMBER 01, 2006
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Type, specification and marking ... 5
5 Design ... 5
6 Requirements ... 6
7 Inspection rules ... 9
8 Packaging ... 9
9 Label ... 10
Annex A ... 12
Annex B ... 18
Annex C ... 19
Bibliography ... 23
Foreword
The general title of YY 0326 is the single-use plasmapheresis centrifuge apparatus; it includes the following parts.
Part 1. Plasma centrifuge bowl;
Part 2. Plasma tubing;
Part 3. Containers for plasma.
Annex A, Annex B, and Annex C in this Part are the standard annexes.
This Part was proposed by the State Drug Administration.
This Part shall be under the jurisdiction of National Standardization Technical Committee of Medical Infusion Apparatus.
The drafting organizations of this Part. Shangdong Medical Instrument Quality Supervision, and Shanghai Transfusion Technology Co., Ltd.
Participating drafting organizations of this Part. Shandong Weigao Group Medical Polymer Co. Ltd., and Shanxi Zhengyuan Science and Technology Development Co., Ltd. Main drafters of this Part. You Shaohua, Jiang Yueqin, Chen Xiaotong, Liu Zhongrang, and Wu Ping.
Plasmapheresis Centrifuge Apparatus for Single Use -
Part 3. Containers for plasma
1??Scope
This Part of YY 0326 specifies the requirements for containers for plasma used together with hemostix specified in YY 0328, plasma tubing specified in YY 0326.2 and plasma centrifuge bowl specified in YY 0326.1. The plasma collected and stored in containers for plasma specified in this Part is used to prepare blood products. It cannot be used for clinical blood transfusion.
2??Normative??references
The articles contained in the following documents have become part of this Part of YY 0326 when they are quoted herein. For the dated documents so quoted, all the modifications (excluding corrections) or revisions made thereafter shall not be applicable to this Part. For the undated documents so quoted, the latest editions shall be applicable to this Part.
GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-1992, neq ISO 3696. 1987)
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1. 1997)
YY 0326.1 Plasmapheresis centrifuge apparatus for single use - Part 1. Centrifuge bowl
YY 0326.2 Plasmapheresis centrifuge apparatus for single use - Part 2. Plasma tubing
YY 0328 Single use blood-taking set for blood processing equipment
3??Terms??and??definitions
The following terms and definitions apply to this Part of YY 0326.
3.1
Container for plasma
It refers to bag container that is designed to be able to connect with the outlet of centrifuge bowl as specified in YY 0326.1 and used to collect plasma.
3.2
Shelf-life
It refers to the period between sterilization time and expiration date; containers for plasma cannot be used to collect plasma if it is beyond the expiration data.
4??Type,??specification??and??marking
4.1 Type and specification
A container for plasma consists of the bag body and intake tubing. The specification of containers for plasma is divided into 600 mL, 800 mL, 900 mL and 1000 mL and so on, according to its nominal capacity.
4.2 Marking example
Containers for plasma are marked by using descriptive words ?€?containers for plasma?€?, the number of this Part of YY 0326, and the nominal capacity of the containers for plasma. For example, the container for plasma complying with the requirements of this Part YY 0326 with capacity of 800mL is marked as.
Container for plasma YY 0326.3 800 mL
5??Design
5.1 General rules
The containers for plasma shall be designed and manufactured to provide safe and convenient for the collection, storage, processing, transfer and separation of plasma. The containers for plasma shall minimize the hazards caused by microbial contamination to collect plasma, and shall be suitable for the centrifuge bowl as specified in YY 0326.1. 5.2 Intake tubing
5.2.1 There shall be an intake tubing in containers for plasma to collect plasma. The intake tubing shall be equipped with a connector matching with centrifuge bowl in accordance with YY0326.1 and protective jacket.
5.2.2 There shall be no rupture and be insolated with the outside when the intake tubing is in normal use.
If the container for plasma is sterilized by ethylene oxide, the ethylene oxide residue shall not be larger than 10??g/g.
Note. GB/T 14233.1 and GB/T 16886.7 specify the testing method and release control of ethylene oxide residue. Adopting the dialysis materials that are easy for in-out of ethylene oxide on single package (such as adopting dialysis paper on one side, while the other side is plastic film composite packing bag. Or attach dialyzing paper on perforated packing paper) can effectively reduce the ethylene oxide residue.
6.4 Biological requirements
6.4.1 General rules
Containers for plasma shall not cause adverse effects to plasma, and shall not release toxic, cytotoxic, antibacterial, sterilization, pyrogen or hemolysis substances. Note. GB/T 16886 gives the general toxicity test methods (see Bibliography). In addition to tests given in clauses C.2 - C.5, the test given in C.6 can be used as guidance.
6.4.2 Microbial impermeability
When test is done according to C.2, containers for plasma shall not be impervious to microorganisms.
6.4.3 Compatibility
When the test is done according to clause C.3, clause C.4 and clause C.5, the container for plasma shall not produce any heat source, toxic or hemolytic reactions substance to plasma.
7??Inspection??rules
7.1 When conducting type inspection, biological evaluation shall be done according to basic rules specified in GB/T 16886.1. Five sets of them shall be inspected at random for physical properties if there is no special provision.
7.2 All type inspection items shall be qualified and shall be passed. When products do not pass the type inspection, mass production must not be launched.
8??Packaging
8.1 8.2 to 8.6 specify the requirements for containers for plasma that are sealed within external packing.
8.2 The manufacturer shall give shelf-life according to the stability data of container for plasma (see 3.2).
8.3 The external packaging material or any treatment at its surface shall not react with container for plasma, and shall be able to prevent mold growth. For example, if using chemical fungicide, certificate that can prove that will not cause harmful penetration or adverse effects shall be provided.
8.4 There shall be obvious opening mark when the seal of external packaging is opened or closed.
8.5 External packaging shall be strong enough in breakage resistance under normal handling and use conditions.
8.6 The placement of containers for plasma and their modules in external packaging shall prevent kink and permanent deformation formed in intake tubing as far as possible. 9??Label
9.1 General rules
The label of containers for plasma shall comply with requirements of relevant national laws and regulations and requirements specified in 9.2 to 9.5. The graphic symbols given in YY 0466 can be used.
9.2 Labels on containers for plasma
If possible, the label shall include the information specified in following a) to i). However, if the space of label is too small, d), e), f) and g) are allowed to be given in instructions for use and not given on the label.
a) Description of the intended use;
b) Volume (mL) or mass (g) of collectable plasma;
c) Explanation for sterile and non-pyrogenic limit conditions;
d) Explanation of prohibition of use for any visible signs of deterioration; e) Explanation for ventilation is not required;
f) Explanation for the single-use of containers for plasma;
g) Description of the use of containers for plasma;
h) The name and address of the manufacturer and/or vendor;
i) Batch number.
Annex??A
(Normative)
Chemical test
A.1 General Rules
The test material shall be taken from the m...

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