YY/T 1432-2016Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength (English PDF)
通过测量热封试样的密封强度确定医疗器械软性包装材料的热封参数的试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1432-2016 is the English-translated version of 通过测量热封试样的密封强度确定医疗器械软性包装材料的热封参数的试验方法.
YY/T 1432-2016 is the Chinese pharmaceutical industry standard that gives the laboratory method for making heat seals in the flexible barrier materials used for medical device packaging and for measuring and evaluating the strength of the seal so produced, which is how the heat sealability of a material is determined.
It sets out the sealing apparatus and the temperature, pressure and dwell time at which the specimens are sealed, the conditioning, the peel test and the way the seal strength is reported.
It does not cover the validation of materials or of production equipment, which belong to the manufacturer's own qualification work. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1432-2016
National Standard of the People's Republic of China
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terminology
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard contains the heat sealing of the soft barrier material in the laboratory and the heat sealing strength data for determining the heat sealability of the material Processing and evaluation. This standard does not include the validation of materials and production equipment.
The method of testing the strength or other properties after heat sealing is not covered by this standard.
This standard applies to the use of heat sealing knife sealing heat sealing machine heat sealing.
This standard is intended primarily for packaging materials intended for heat sealing on commercially available machines with reciprocating heat sealing knives such as forming Equipment - sealed (FFS) packaging machine, flat heat sealing machine. The duration of this machine and heat sealing pressure conditions are different from rolling heat sealing machines.
The procedures specified in this standard relating to the choice of heat seal conditions apply to the cold seal strength (ultimateseal) or thermal seal strength (hottack) determination.
The method specified in this standard applies to the determination of heat sealing parameters between the same or different packaging materials.
Note. Single packaging material structure can be homogeneous or can be multi-layer (co-extruded, coated, composite, etc.).
This standard does not include determining the heat sealability by determining the continuity of the seal (leakage, dyeing, penetration, visualization, microbial penetration, etc.).
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.
GB/T 2918 Standard conditions for the regulation and testing of plastic specimens
YY/T 0681.2 Test methods for sterile medical device packaging - Part 2. Sealing strength of soft barrier materials
3 Terminology
The following terms and definitions apply to this document.
3.1 Dwell time
The heat seal is closed and the pressure period is continuously applied to the heat seal material.
3.2 Heat sealing curve
The measured seal strength corresponds to the heat seal temperature when the duration and pressure are constant.
Note. This is the basic curve for comparing the sealing properties of materials. It depicts the retention time and pressure when the same, peel the heat seal after the test strip to destroy the required force, the force The value is a function of temperature. The influence of substrate damage at the higher heat sealing temperature of the curve can not accurately indicate the sealing strength.
3.3 Heat seal strength
The force required to peel the sealing area of the unit seal width.
Note. In many seal strength tests, damage does not occur at the seal, but occurs at the substrate or composite layer. In these tests, the actual heat density The sealing strength may be higher than the force measured when the specimen is destroyed. Some materials are expected to be designed to break on the composite layer without damaging the heat seal interface.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB/T 2918-2018 — Plastics -- Standard atmospheres for conditioning and testing
YY/T 0681.2-2010 — Test methods for sterile medical device package - Part 2: Seal strength of flexible barrier materials
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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