YY 0804-2010Transfer sets for pharmaceutical preparations—Requirements and test methods (English PDF)
药液转移器 要求和试验方法
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY 0804-2010 is the English-translated version of 药液转移器 要求和试验方法.
YY 0804-2010 is the Chinese pharmaceutical industry standard for the sterilized single-use transfer set used with pharmaceutical preparations, the set through which a preparation is drawn from its container and transferred.
It sets the requirements and the test methods for it, covering the spike and the connectors, the flow rate, the strength and tightness of the assembly, the freedom from particles, the chemical requirements on the extract and the biological evaluation of the materials, and sterility, together with the labelling and the information supplied. Issued on 27 December 2010, it applies from 1 June 2012.
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Document preview — YY 0804-2010
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Design and designation6
- 4 Materials9
- 5 Physical requirements9
- 6 Chemical requirements11
- 7 Biological requirements11
- 8 Test methods11
- 9 Test method for chemical requirements12
- 10 Test method for biological requirements13
- 11 Packaging13
- 12 Storage13
- 13 Labelling13
- Annex A (Normative) Testing method on fragmentation for transfer sets with plastic piercing device15
- Annex B (Normative) Testing method on fragmentation for transfer sets with metal piercing device17
- Annex NA (Normative) Technical differences between this Standard and ISO22413:2007 and their reasons19
- Bibliography20
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.
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. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
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