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Position: Chinese Standard in English/YY/T 0681.6-2011
YY/T 0681.6-2011   Test methods for sterile medical device package—Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials (English Version)
Standard No.: YY/T 0681.6-2011 Status:valid remind me the status change

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Standard No.: YY/T 0681.6-2011
English Name: Test methods for sterile medical device package—Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
Chinese Name: 无菌医疗器械包装试验方法 第6部分:软包装材料上印墨和涂层抗化学性评价
Chinese Classification: C31    General and microsurgical devices
Professional Classification: YY    Professional Standard - Pharmaceutics
Source Content Issued by: China Food and Drug Administration
Issued on: 2011-12-31
Implemented on: 2013-6-1
Status: valid
Target Language: English
File Format: PDF
Word Count: 4000 words
Translation Price(USD): 120.0
Delivery: via email in 1 business day
1 Scope This part of YY/T 0681 describes the evaluation procedures of chemical contact bearing capacity of printed inks, finishing varnish or coatings on the upper layer of printing. Typical chemicals that may come into contact with packaging include water, ethanol, acid, etc. For special chemicals, the methods shall be selected and measurement results shall be determined through discussion and negotiation with users. The methods listed in this part provide suggestions for test methods and information collection. 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 2918 Plastics — Standard atmospheres for conditioning and testing 3 Significance and use 3.1 Packaging materials may come into contact with chemicals such as water, ethanol and acid during their life cycle. If the packaging material is expected to come into contact with chemicals, it is important that the inks or coatings do not degrade, soften or dissolve after contact. 3.2 The tests included in this part are applicable to surfaces with printing and coating materials designed to be stable to a specific chemical. 3.3 The test chemicals should be compatible with printed and/or coated substrates (i.e., not damaged or degraded). 3.4 This part details four methods. These methods are gradually stricter from Method A to Method D. The method should be selected according to the expected contact type. For example, pouring method (Method A) is expected to be used for accidental contact (e.g., pouring chemicals on the surface of materials). When the desired chemical resistance depends on the expected contact level (B) or wiping level (C), Method B or C is used respectively. Method D indicates that materials are in constant contact with chemicals and need to be chemically resistant (e.g., the package is soaked in chemicals for a certain period and wiped).
Foreword i 1 Scope 2 Normative references 3 Significance and use 4 Apparatus 5 Sampling 6 Conditioning 7 Procedure 8 Report
Referred in YY/T 0681.6-2011:
*GB/T 2918-2018 Plastics--Standard atmospheres for conditioning and testing
Code of China
Standard
YY/T 0681.6-2011  Test methods for sterile medical device package—Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials (English Version)
Standard No.YY/T 0681.6-2011
Statusvalid
LanguageEnglish
File FormatPDF
Word Count4000 words
Price(USD)120.0
Implemented on2013-6-1
Deliveryvia email in 1 business day
Detail of YY/T 0681.6-2011
Standard No.
YY/T 0681.6-2011
English Name
Test methods for sterile medical device package—Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
Chinese Name
无菌医疗器械包装试验方法 第6部分:软包装材料上印墨和涂层抗化学性评价
Chinese Classification
C31
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2011-12-31
Implemented on
2013-6-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
4000 words
Price(USD)
120.0
Keywords
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Introduction of YY/T 0681.6-2011
1 Scope This part of YY/T 0681 describes the evaluation procedures of chemical contact bearing capacity of printed inks, finishing varnish or coatings on the upper layer of printing. Typical chemicals that may come into contact with packaging include water, ethanol, acid, etc. For special chemicals, the methods shall be selected and measurement results shall be determined through discussion and negotiation with users. The methods listed in this part provide suggestions for test methods and information collection. 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 2918 Plastics — Standard atmospheres for conditioning and testing 3 Significance and use 3.1 Packaging materials may come into contact with chemicals such as water, ethanol and acid during their life cycle. If the packaging material is expected to come into contact with chemicals, it is important that the inks or coatings do not degrade, soften or dissolve after contact. 3.2 The tests included in this part are applicable to surfaces with printing and coating materials designed to be stable to a specific chemical. 3.3 The test chemicals should be compatible with printed and/or coated substrates (i.e., not damaged or degraded). 3.4 This part details four methods. These methods are gradually stricter from Method A to Method D. The method should be selected according to the expected contact type. For example, pouring method (Method A) is expected to be used for accidental contact (e.g., pouring chemicals on the surface of materials). When the desired chemical resistance depends on the expected contact level (B) or wiping level (C), Method B or C is used respectively. Method D indicates that materials are in constant contact with chemicals and need to be chemically resistant (e.g., the package is soaked in chemicals for a certain period and wiped).
Contents of YY/T 0681.6-2011
Foreword i 1 Scope 2 Normative references 3 Significance and use 4 Apparatus 5 Sampling 6 Conditioning 7 Procedure 8 Report
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