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YY 0804-2010 PDF English

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YY 0804-2010: [YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods
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Status: Obsolete
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YY 0804-2010340 Add to Cart Auto, 9 seconds. [YY/T 0804-2010] Transfer sets for pharmaceutical preparations. Requirements and test methods Obsolete

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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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