YY 0804-2010 PDF English
US$340.00 · In stock · Download in 9 secondsYY 0804-2010: [YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0804-2010 | English | 340 |
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[YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods
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YY 0804-2010: [YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0804-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
C 31
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
Foreword
This Standard adopts ISO 22413.2007 Transfer sets for pharmaceutical preparations -
Requirements and test methods and ISO 22413.2007/ADM1 (Draft amendment) by
modification.
This Standard shall be under the jurisdiction of National Technical Committee 106 on
Medical Syringes of Standardization Administration of China.
Drafting organizations of this Standard. Shandong Quality Inspection Center for
Medical Devices, Shandong Weigao Group Medical Polymer Company Limited.
Main drafters of this Standard. Song Jinzi, Yu Xin, Wang Jinhong, Zheng Xiaoye.
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)
3 Design and designation
The design of a transfer set with housing is given in Figure 4.The drawing serves as an
illustration of a possible transfer set with housing. Other designs are acceptable.
4 Materials
The materials for the transfer sets and their individual components shall conform to the
requirements in Clause 5.If the components are exposed to the liquid to be transferred,
the chemical and biological requirements in GB 8368 shall be met.
5 Physical requirements
The protective caps at the ends of the transfer set shall keep the closure sterile. When
tested according to 8.9, protective caps should be firm and cannot fall off naturally, but
easily removable without touching the protected part.
Protective caps should be suitable for the intended sterilization process.
6 Chemical requirements
The requirements of GB 8368 shall be met.
7 Biological requirements
The requirements of GB 8368 shall be met.
8 Test methods
Visually inspect if the lumen is free of contractions.
Verification shall be carried out by simulating clinical operations.
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.
10 Test method for biological requirements
The requirements of GB 8368 shall be met.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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