YY 0804-2010 English PDF

YY 0804-2010: [YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods
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YY/T 0804-2010 (Renamed from YY 0804-2010)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0804-2010
Transfer sets for pharmaceutical preparations -
Requirements and test methods
(ISO 22413:2007, MOD)
According to the Announcement (No. 76, 2022) of the Medical Device Industry
Standards of the State Drug Administration of the people’s Republic of China, this
Standard is converted to a recommended standard from September 7, 2022, and is no
longer mandatory.
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: State Drug Administration of the people’s Republic of China
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Design and designation ... 6
4 Materials ... 9
5 Physical requirements ... 9
6 Chemical requirements ... 11
7 Biological requirements ... 11
8 Test methods ... 11
9 Test method for chemical requirements ... 12
10 Test method for biological requirements ... 13
11 Packaging ... 13
12 Storage ... 13
13 Labelling ... 13
Annex A (Normative) Testing method on fragmentation for transfer sets with plastic
piercing device ... 15
Annex B (Normative) Testing method on fragmentation for transfer sets with metal
piercing device ... 17
Annex NA (Normative) Technical differences between this Standard and
ISO22413:2007 and their reasons ... 19
Bibliography ... 20
Transfer sets for pharmaceutical preparations -
Requirements and test methods
1 Scope
This Standard applies to sterilized single-use transfer sets for pharmaceutical
preparations.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2001,
ISO 594-1:1986, IDT)
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001, ISO 594-
2:1998, IDT)
GB 8368, Infusion sets for single use - Gravity feed (GB 8368-2005, ISO 8536-
4:2004, MOD)
GB 15811-2001, Sterile hypodermic needles for single use (eqv ISO 7864:1993)
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements (YY 0466.1-
2009, ISO 15223-1:2007, IDT)
ISO 8362, Injection containers and accessories
ISO 8536-2, Infusion equipment for medical use - Part 2: Closures for infusion
bottles
ISO 15747:2003, Plastic containers for intravenous injections
ISO15759:2005, Medical infusion equipment - Plastics caps with inserted
elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
Visually inspect if the surface of the piercing device is smooth and free from burrs.
Measure if the diameter conforms to 5.5.
8.6 Penetration force
8.6.1 For plastic piercing devices, testing shall be in accordance with ISO 8536-2:2001,
Annex B.
8.6.2 For metal piercing devices, testing shall be in accordance with ISO 8362-2:1988,
Annex B.
Note: For the transfer set with two channels shown in Figure 3a), one of the metal
needles shall be removed with a suitable tool before the test.
8.7 Testing on fragmentation
8.7.1 For plastic piercing devices, testing shall be in accordance with Annex A.
8.7.2 For metal piercing devices, testing shall be in accordance with Annex B.
Note: For the transfer set with two channels shown in Figure 3a), one of the metal
needles shall be removed with a suitable tool before the test.
8.8 Effectiveness of air inlet and outlet with air filter
Testing shall be carried out according to GB 8368.
8.9 Effectiveness of protective caps
Verification shall be carried out by simulating clinical operations.
8.10 Luer tapers
According to GB/T 1962.1 or GB/T 1962.2
8.11 Particulate filter
The integrity of the installed particulate filter must be tested.
9 Test method for chemical requirements
Preparation of test solution: for transfer devices with hoses, prepare test solution
according to GB 8368; for other types of transfer devices, add 10 mL of water per piece
(the part in contact with the pharmaceutical preparation), and extract for 2 hours at
37 °C ±1 °C to prepare test solution.
The requirements of GB 8368 shall be met.
YY/T 0804-2010 (Renamed from YY 0804-2010)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0804-2010
Transfer sets for pharmaceutical preparations -
Requirements and test methods
(ISO 22413:2007, MOD)
According to the Announcement (No. 76, 2022) of the Medical Device Industry
Standards of the State Drug Administration of the people’s Republic of China, this
Standard is converted to a recommended standard from September 7, 2022, and is no
longer mandatory.
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: State Drug Administration of the people’s Republic of China
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Design and designation ... 6
4 Materials ... 9
5 Physical requirements ... 9
6 Chemical requirements ... 11
7 Biological requirements ... 11
8 Test methods ... 11
9 Test method for chemical requirements ... 12
10 Test method for biological requirements ... 13
11 Packaging ... 13
12 Storage ... 13
13 Labelling ... 13
Annex A (Normative) Testing method on fragmentation for transfer sets with plastic
piercing device ... 15
Annex B (Normative) Testing method on fragmentation for transfer sets with metal
piercing device ... 17
Annex NA (Normative) Technical differences between this Standard and
ISO22413:2007 and their reasons ... 19
Bibliography ... 20
Transfer sets for pharmaceutical preparations -
Requirements and test methods
1 Scope
This Standard applies to sterilized single-use transfer sets for pharmaceutical
preparations.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2001,
ISO 594-1:1986, IDT)
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fittings (GB/T 1962.2-2001, ISO 594-
2:1998, IDT)
GB 8368, Infusion sets for single use - Gravity feed (GB 8368-2005, ISO 8536-
4:2004, MOD)
GB 15811-2001, Sterile hypodermic needles for single use (eqv ISO 7864:1993)
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements (YY 0466.1-
2009, ISO 15223-1:2007, IDT)
ISO 8362, Injection containers and accessories
ISO 8536-2, Infusion equipment for medical use - Part 2: Closures for infusion
bottles
ISO 15747:2003, Plastic containers for intravenous injections
ISO15759:2005, Medical infusion equipment - Plastics caps with inserted
elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
Visually inspect if the surface of the piercing device is smooth and free from burrs.
Measure if the diameter conforms to 5.5.
8.6 Penetration force
8.6.1 For plastic piercing devices, testing shall be in accordance with ISO 8536-2:2001,
Annex B.
8.6.2 For metal piercing devices, testing shall be in accordance with ISO 8362-2:1988,
Annex B.
Note: For the transfer set with two channels shown in Figure 3a), one of the metal
needles shall be removed with a suitable tool before the test.
8.7 Testing on fragmentation
8.7.1 For plastic piercing devices, testing shall be in accordance with Annex A.
8.7.2 For metal piercing devices, testing shall be in accordance with Annex B.
Note: For the transfer set with two channels shown in Figure 3a), one of the metal
needles shall be removed with a suitable tool before the test.
8.8 Effectiveness of air inlet and outlet with air filter
Testing shall be carried out according to GB 8368.
8.9 Effectiveness of protective caps
Verification shall be carried out by simulating clinical operations.
8.10 Luer tapers
According to GB/T 1962.1 or GB/T 1962.2
8.11 Particulate filter
The integrity of the installed particulate filter must be tested.
9 Test method for chemical requirements
Preparation of test solution: for transfer devices with hoses, prepare test solution
according to GB 8368; for other types of transfer devices, add 10 mL of water per piece
(the part in contact with the pharmaceutical preparation), and extract for 2 hours at
37 °C ±1 °C to prepare test solution.
The requirements of GB 8368 shall be met.