GB 14232.3-2011Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features (English PDF)

4.1 Dimensions

Figures 1 and 2 shows a blood bag system as specific components of the composition, the total of the components illustrated in Figure and only guide. Size should be consistent

4.1 GB 14232.1-2004 in Figure 1 below.

4.2 tag example

Thumbnail plastic container with a special assembly of descriptive words "plastic bags" plus GB 14232 this part number, plus given in Chapter 3

word. For example, in line with GB 14232 labeled plastic bags with leukocyte filter requirements of this section are.

Plastic bags GB 14232.3-LCF

5.1 to leukocyte filter

5.1.1 plastic bags in the leukocyte filter for whole blood or blood component filtration. It is designed to reduce whole blood or blood components in

White blood cells, the filter can be designed at 4 °C or gravity filtration at ambient temperature and pressure filter according to the technical specification requirements.

Leukocyte filter can also be installed on other transfusion equipment.

Leukocyte filter may need to meet national standards 1).

1) See YY0329-2002.

5.1.2 The manufacturer shall recommend to filter out white blood cells intended use, the relevant parameters include.

--- Blood collection and filtration of leukocytes delay time between;

--- Filtering capabilities;

--- Blood filtration temperature;

--- Filter height;

--- Working pressure;

--- Centrifugal suitability.

5.2 pre-donation sampling means

5.2.1 pre-donation sampling device should be able to state a sterile blood sample collected in vacuum blood collection tube.

5.2.2 If the first blood sampling device comprising a blood collection bags having a capacity of at least 35mL.

5.2.3 pre-donation sampling devices shall be designed so that when you press the test of GB 14232.1-2004 Section B.2, which charged an average flow rate of at least

50mL/min.

5.2.4 blood sampling device shall be taken before and after harvest to prevent bleeding into the sample and (or) air from the sampling point to the blood donors and blood bags backflow device.

The apparatus may be integral may be separated.

For specific blood collection, blood donation may be required before sampling without anticoagulant and to avoid hemolysis.

5.2.5 The manufacturer shall give advice pre-donation sampling means optimal use.

5.3 bottom bags

5.3.1 ships with a top end of the bag for use with automatic pressurization system, can by means of a device such as an optical sensor or the like, between the upper lower

Leukocyte and platelet rich layer components (buffy coat) remain in the blood bag.

5.3.2 If the top outlet and bottom outlet of different caliber, the manufacturer should be required to give its customers should be able size.

5.4 platelet storage bag

5.4.1 platelet storage bag should have good ventilation, so that the oxygen and carbon dioxide through, and should be stored under controlled temperature conditions

Platelet concentrates number of days (in the oscillation storage conditions).

5.4.2 Effect of platelet storage is also affected by platelet count, platelet concentrates the volume of container specifications and oscillations and other factors, usually through

Observing vortex (swirling), measuring pH, hypotonic shock reaction and the reaction is evaluated clustering.

5.5 Anti-needle protection device

The manufacturer shall give advice needle protection device preventing the best use.

Anti-needle protection devices may be required by the national standard.

5.6 air content

When calculated according to GB 14232.1-2004 air content, if the design or operation of the system does not make the filter assembly or before blood sampling

Contained in the air bag of blood components into the final air volume calculation does not have to include these components in the air.

For other vessels, such as the top end of the bag, platelet storage bags, when they last used the system storage containers, air volume limit requirement

Still apply.

6.1 General applicable applicable applicable applicable applicable a

Physical Requirements 6.2 plastic bags and each special assembly

6.2.1 Production Conditions Applicable Applicable Applicable Applicable Applicable

6.2.2 Sterilization

6.2.2.1 sterilization method is applicable applicable applicable applicable applicable

6.2.2.2 Sterilization adverse effects Applicable Applicable Applicable Applicable Applicable

6.2.2.3 sterilization effectiveness Applicable Applicable Applicable Applicable Not Applicable

6.2.3 Transparency applicable Not applicable Not applicable applicable applicable

6.2.4 Color Not applicable applicable applicable applicable not applicable

6.2.5 Thermal stability Not applicable Not applicable Not applicable applicable applicable

6.2.6 steam revealing applicable Not applicable Not applicable Not applicable Not applicable b

6.2.7 c anti-leak applicable applicable applicable applicable not applicable d

6.2.8 particulate pollution applicable applicable applicable applicable not applicable

6.3 Chemical requirements

6.3.1 original container or sheet requirements applicable Not applicable Not applicable applicable applicable e

6.3.2 Test fluid requirement does not apply f e applicable applicable applicable not applicable

6.4 Requirements Biology

6.4.1 General Applicable Applicable Applicable Applicable Not Applicable

6.4.2 g microbial impermeability applicable Not applicable applicable applicable applicable h

6.4.3 Compatibility Applicable Applicable Applicable Applicable Not Applicable

a leukocyte filter is not necessarily soft.

b in a given storage period of time, the permeability of the material is conducive to maintaining the vitality of platelets, platelet storage bag see special requirements.

c depending on the type of leukocyte filter, the filter should be able to withstand the maximum pressure under normal operating conditions (ie, the maximum hydrostatic head pressure of gravity or plasma transfusions when

force).

D before blood sampling bags should be able to withstand the pressure test, the test except centrifugation and 4 °C.

e applies only to the container.

f filter should satisfy the biochemical requirements for plastic pharmacopoeia given.

g leukocyte filter housing must be impervious to microorganisms. The filter is not expected to remove blood and blood components in microorganisms.

h applies only sampling bags. Transfer blood bag for blood collection tube before blood sampling point should be permanently sealed.

7.1 Scope Applicable Applicable Applicable Applicable

7.2 storage life Applicable Applicable Applicable Applicable Applicable

7.3 packaging material suitable for a applicable applicable applicable applicable a a

7.4 outer seal Applicable Applicable Applicable Applicable Applicable

7.5 packaging intensity applicable applicable applicable applicable applicable

7.6 packaging in place applicable applicable applicable applicable applicable

these components do not need a special offer specialized packaging.

8.1 General applicable applicable applicable applicable applicable

8.2 Each labeling requirements for plastic bags and special components

8.2a) and was built using the Optional Optional Applicable Applicable Not Applicable

8.2b) anticoagulant/preservative solution and recipe collection volume applicable Not applicable Not applicable Not applicable applicable

8.2c) sterile, non-pyrogenic Description Not applicable Not applicable Not applicable applicable applicable

8.2d) metamorphic Description Not applicable Not applicable Not applicable applicable applicable

8.2e) without ventilation Description Not applicable Not applicable Not applicable applicable applicable

8.2f) Disposable Description Not applicable Not applicable Not applicable applicable applicable

8.2g) Description Not applicable Not applicable Not applicable applicable applicable

8.2h) manufacturer/supplier Not applicable Not applicable Not applicable applicable applicable

8.2i) batch identification optional applicable Not applicable Not applicable applicable

8.3 blood bag system packaging label

8.3a) manufacturer/supplier apply

8.3b) contents a description of applicable applicable applicable applicable applicable a a

8.3c) the expiry date applicable

8.3d) after removal from the packaging instructions apply to the expiration date

8.3e) Lot applicable

Table 3 (Continued)

Claim

(GB 14232.1-2004 bars and phrases)

Leukocyte

filter

Pre-donation

Sampling means

The top end of the bag

Blood platelet

Storage bag

Anti-acupuncture Paul

Protection device

8.4 label on the blood bag system shipping box

8.4a) manufacturer/supplier apply

8.4b) contents instructions apply

8.4c) Storage conditions apply

8.4d) batch identification applicable

8.4e) Expiration date applies

8.4f) After removing the packaging from the expiry of the applicable instructions

8.5 Each labeling requirements for plastic bags and special components

8.5a) area of the factory and use information Optional Optional Applicable Applicable Not Applicable

8.5b) was built to facilitate the vision test applicable applicable applicable applicable not applicable

8.5c) to ensure that printing is not seep applicable applicable applicable applicable not applicable

8.5d) printing when using the label remains clearly applicable applicable applicable applicable not applicable

Suitability applicable applicable applicable applicable 8.5e) label pasted NA

8.5f) tore signs Applicable Applicable Applicable Applicable Not Applicable

8.5g) should test by GB 14232.1 Chapter B.3 chapter applicable Not applicable Not applicable Not applicable applicable b

which should include a description of the special assembly.

Permanent labels need not include a test -30 °C frozen.