YY/T 1494-2016Packaging materials for haemodialysis and related therapeutic concentrates—General requirements (English PDF)
血液透析及相关治疗用浓缩物包装材料通用要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1494-2016 is the English-translated version of 血液透析及相关治疗用浓缩物包装材料通用要求.
YY/T 1494-2016 is the Chinese pharmaceutical industry standard that sets the general technical requirements for the packaging materials of the concentrates used in haemodialysis and related therapies.
It gives the classification and the characteristics of these materials, the requirements, the test methods and the rules for the signs, the packaging, the transport and the storage, covering the barrier properties of the container, the substances that may migrate into the concentrate, the strength and tightness of the package and the labelling. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1494-2016
National Standard of the People's Republic of China
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 4 Requirements
- 5 Test method
- 6 mark, packing, transportation, storage
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the general technical requirements for quality inspection of concentrate packaging materials for hemodialysis and related therapies, including classification and traits, Requirements, test methods and signs, packaging, transportation, storage.
This standard applies to hemodialysis and related treatment with concentrated packaging materials.
This standard does not apply to the central supply of liquid and hospital preparation of concentrated liquid packaging materials.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
Plastics - Films and sheets - Permeability test method - Cup method Standard Test Method for Gas Permeability of Plastic Films and Flakes - Differential Pressure Method GB/T Standard Test Method for Drinking Water of Metals - Metals Indicators GB/T 5750.6-2006
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods Concentration of hemodialysis and related therapies YY 0598 Pharmacopoeia of the People's Republic of China (2010 edition 2)
Classification and traits 3.1 concentrate packaging materials are generally divided into concentrated packaging materials and dry powder packaging materials.
3.2 Concentrated liquid packaging materials are generally high-density polyethylene
(HDPE), low-density polyethylene (LDPE), polyethylene terephthalate (PET) and so on.
3.3 Dry powder packaging materials
Dry powder packaging materials are generally divided into low-density polyethylene (LDPE), polyethylene (PE), polypropylene (PP), PTP aluminum foil, Materials, nylon/PE composite film materials, SP composite membrane materials.
3.4 Materials in direct contact with the concentrate
Direct contact with the concentrate packaging materials should be used above the food level (including food grade) raw materials production.
4 Requirements
4.1 Concentrate packaging materials requirements
4.1.1 Appearance
Concentrated liquid packaging materials should be uniform and consistent color, no obvious color; the surface should be smooth, smooth, no deformation and obvious rub Marks; no trachoma, oil, bubbles; barrel mouth should be smooth, smooth.
4.1.2 Identification of infrared spectroscopy
Infrared spectroscopy identification, should be consistent with the control map.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1494-2016
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