Co-extrusion films for the vaccum thermoforming packaging of medical devices
Some standard content:
ICS55.040
Packaging Industry Standard of the People's Republic of China
BB/T 0059—2012
Co-extrusion films for thec vaccum thermoforming packaging of medical devices2012-05-24Published
2012-11-01Implementation
The Ministry of Industry and Information Technology of the People's Republic of China issued a sea of devices
Material packaging types
I feel the smoke hall
Announcement of the Ministry of Industry and Information Technology of the People's Republic of China
No. 20 of 2012
The Ministry of Industry and Information Technology approved 464 industry standards including "Airless Sprayer" (standard number, name, main content and starting date of implementation see Appendix 1), including: 170 mechanical industry standards, 105 light industry standards, 47 textile industry standards, metallurgy industry standards 23 industry standards, 30 nonferrous industry standards, 38 chemical industry standards, 5 petrochemical industry standards, 2 building materials industry standards, 13 pharmaceutical equipment industry standards, 1 packaging industry standard, 2 gold industry standards, 6 shipbuilding industry standards, 13 civil explosive industry standards, 4 electronics industry standards, and 5 communications industry standards were approved; 6 nonferrous industry standard samples including "Spectral Standard Sample of Deformed Aluminum Alloy 3003" were approved (see Appendix 2 for the catalog and composition of standard samples); 1 mechanical industry standard amendment sheet JB/T3300-2010 "Complete Counterbalanced Forklift Test Method" was approved (see Appendix 3), and now it is announced. The above 6 nonferrous industry standard samples and 1 mechanical industry standard amendment sheet will be implemented from the date of publication. The above mechanical industry standards are published by the Electric Machinery Industry Press, textile, nonferrous metal and gold industry standards are published by China Standard Press, light industry standards are published by China Light Industry Press, metallurgical industry standards are published by Metallurgical Industry Press, chemical industry product standards are published by Chemical Industry Press, petrochemical industry standards are published by China Petrochemical Press, building materials industry standards are published by Building Materials Industry Press, chemical industry engineering construction standards, packaging industry standards and pharmaceutical equipment industry standards are published by China Planning Press, shipbuilding industry standards are published by China Shipbuilding Industry Comprehensive Technology and Economic Research Institute, civil explosives industry standards are published by China Ordnance Standardization Institute, electronics industry standards are published by the Electronic Industry Standardization Research Institute of the Ministry of Industry and Information Technology, and communications industry standards are published by People's Posts and Telecommunications Press. Attachment: 1 packaging industry standard number, standard name and start date of implementation. Ministry of Industry and Information Technology of the People's Republic of China May 24, 2012
Appendix:
1 Number, name and starting date of implementation of packaging industry standard Standard number
BB/T0059—2012
Standard name
Co-extruded film for blister packaging of medical devices
Replaced standard number
Starting date of implementation
2012-11-01
Scope·
2 Normative references
3 Terms and definitions
4 Product categories...
5 Requirements
6 Test methods
Inspection rules -
Marking, packaging, transportation and storage
.+.....
BB/T 00592012
......
BB/T0059—2012
This standard was drafted in accordance with the rules of GB/T1.1--2009. This standard is under the jurisdiction of the National Technical Committee for Packaging Standardization (SAC/TC49). The drafting unit of this standard: Ningbo Hua-Ka Packaging Co., Ltd. The main drafters of this standard: Chen Yifeng, Peng Mao, Lu Ting, Wang Meihua. 1 Scope
Co-extruded film for blister packaging of medical devices
BB/T0059--2012
This standard specifies the product classification, requirements, test methods, inspection rules, marking, packaging, transportation and storage of co-extruded film for blister packaging of medical devices (hereinafter referred to as packaging film). This standard is applicable to films that can be made of polyolefin (PI), polyamide (PA) and polyethylene (PE) as raw materials and are formed by co-extrusion process according to different structures.
This standard does not apply to medical devices implanted in the human body. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated reference, only the version with the date is applicable to this standard. For any undated reference, the latest version (including all amendments) is applicable to this standard.
Packaging storage and transportation graphic label
GB/T 191
CB/T1040.3 Determination of tensile properties of plastics Part 3: Test conditions for films and sheets GB/T2035 Plastic terms and definitions
GB/T2410 Determination of light transmittance and haze of transparent plastics GB/T2828.1 Sampling inspection procedure by attributes Part 1: Sampling plan for batch inspection based on acceptance quality limit (AQL) GB/T2918 Standard environment for conditioning and testing of plastic specimens 6B/5672 Determination of thickness of plastic films and sheets Mechanical measurement method GR/T6673 Determination of length and width of plastic film and sheet GB/T14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T16886.5 Biological evaluation of medical devices Part 5: In vitro cytotoxicity test GB/T16886.10 Biological evaluation of medical devices Part 10: Irritation and delayed hypersensitivity test 3 Terms and definitions
Terms and definitions defined in GB/T2035 are applicable to this standard. 4 Product classification
4.1 According to the different materials of packaging film, it is divided into:
a) Multi-layer co-extruded packaging film containing PP and PE; b) Multi-layer co-extruded packaging film containing PA and PE; c) Multi-layer co-extruded packaging film containing PA and PP. 4.2 Classification according to the thickness of packaging film is shown in Table 1. BB/T0059—2012
5 Requirements
5.1 Raw materials
Raw materials should meet the relevant requirements of food grade or above. 5.2 Dimensional deviation
Classification by thickness
Thickness (μm)
100~150
5.2.1 Degree and deviation should comply with the provisions of Table 2. Table 2 Thickness and deviation
Width deviation range is +3mm
Thickness (μm)
100~150
The number of joints per roll of membrane and the length of each section should comply with the provisions of Table 3. Table 3 Number of joints per roll and length of each section
Length of each roll (m)
Number of joints (pieces)
5.2.3.1 The number of membrane rolls with joints shall not exceed 10% of the batch. 5.2.3.2 The joints shall be aligned and firmly connected with tape and clearly marked. 5.3 Appearance quality
The appearance quality shall comply with the requirements of Table 4.
Table 4 Appearance quality
Dislocation of film roll end face, mm
Flatness of end face
Wrinkles, ribs
Piercing, damage, pressure, oil stain
Film roll tube core
Average deviation (%)
Length of each section (m)
The film roll has no obvious looseness or tightness, and no grain on both ends. Edge warping is not allowed
No obvious longitudinal stripes
Not allowed
No radial indentation or notch that affects the use
No impact on the use
Not allowed
5.4 Physical and mechanical properties
5.4.1 The physical and mechanical properties of packaging films containing PP and PE shall comply with the provisions of Table 5. Table 5 Physical and mechanical properties of packaging films containing PP and PE No.
Fog (%)
Tensile strength (MPa)
Tensile break nominal strain (%)
Longitudinal, transverse
Longitudinal, transverse
The physical and mechanical properties of packaging films containing PA and PF shall comply with the provisions of Table 6. Refers to
≥350
Physical and mechanical properties of packaging films containing PA and PE Table 6
Fog (%)
Tensile strength (MPa)
Tensile break nominal strain (%)
Longitudinal, transverse
Longitudinal, transverse
The physical and mechanical properties of packaging films containing PA and PP shall comply with the provisions of Table 7. R
Physical and mechanical properties of packaging films containing PA and PPTable 7
Fog (%)
Tensile strength (MPa)
Nominal strain at break (%)
Biological properties
Biological properties shall comply with the provisions of Table 8.
Longitudinal, axial
Longitudinal, sulfonated
Table 8 Biological properties
Cytotoxicity
Sensitizing reaction
Skin irritation
BB/T0059—2012
≥300
Relative proliferation rate ≤1 level
Sensitizing reaction ≤level
Should have no irritation
BB/T0059—2012
5.6 Heavy metals
Heavy metals shall comply with RoHS standards.
6 Test method
6.1 Sample state adjustment and test environment
Perform the test in the standard environment specified in GB/T2918. The state adjustment time is not less than 4h, and the test is carried out under this condition. Test environment conditions: temperature is 23℃±2%℃, relative humidity is 50%±5%c6.2 Sampling
When sampling the roll film, remove the three layers on the surface, take a 2m long sample, and cut it along the longitudinal direction of the roll film for sampling6.3 Small deviation
6.3.1 The thickness deviation of the packaging film shall be carried out in accordance with the provisions of GB/T6672. 6.3.2 The length and width deviation of the packaging film shall be carried out in accordance with the provisions of GB/T6673. 6.4 Appearance quality
Visually inspect under natural light and measure with a measuring tool with an accuracy of not less than 0.5mm. 6.5 Physical and mechanical properties
6.5.1 Haze.
Perform the test in accordance with the provisions of GB/T2410.
6.5.2 Tensile strength, nominal strain at break: According to the provisions of (R/T1040.3, the selected specimen is type 2 and the test speed is 500m/mim50mm/min. The results are expressed as the arithmetic mean of 6 specimens in each group, and two significant figures are taken. 6.6 Biological properties
6.6.1 Cytotoxicity.
According to the provisions of GB/T16886.5 in vitro cytotoxicity test. 6.6.2 Sensitization reaction and skin irritation,
According to the provisions of GR/T16886.10 stimulation and irritation type hyperreaction test. 6.7 Heavy metals
Heavy metals are tested according to the provisions of GB/T14233.1. 7 Inspection rules
7.1 Batch
The packaging film is measured in batches. For inspection, products of the same variety, same specification, same process and same raw materials that are continuously produced are considered a batch, and the maximum batch of packaging film shall not exceed 1,200 rolls. 7.2 Inspection classification
7.2.1 "Outgoing inspection".
The factory inspection items are the items specified in Table 2, Table 3, Table 4, Table 5, Table 6 and Table 7. 7.2.2 Type inspection.
The inspection items are all the items specified in the requirements. Type inspection shall be carried out in any of the following circumstances: 4
a) When trial production and identification of new products is carried out;
b) When there are major changes in raw materials and processes that may affect product performance; c) When there are major differences between the factory inspection results and the type inspection results; d) When the national quality supervision agency proposes the requirement for type inspection; 7.3 Sampling
BB/T 0059—2012
7.3.1 Appearance quality and dimensional deviation are sampled and inspected in accordance with the provisions of GB/T2828.1. The normal inspection one-time sampling plan is adopted. The general inspection level is 11, and the acceptance quality limit is AQL6.5. 7.3.2 Physical and mechanical properties and physical properties are random sampling methods. Sufficient test samples are selected from each batch. 7.4 Judgment rules
7.4.1 Judgment of sample unit quality.
Take one roll as the sample unit, and all items are qualified on average. The sample unit is qualified: 7.4.1.1 Appearance quality and dimensional deviation If all items are qualified, the appearance quality and dimensional deviation of this batch of products are qualified. 7.4.1.2 If the physical and mechanical properties meet the requirements of the standard, the physical and mechanical properties of this batch are qualified. If there are unqualified items, double samples are drawn from the batch for re-inspection of the unqualified items. If all the re-inspection results are qualified, the batch is qualified. 7.4.1.3 If all items of biological performance and heavy metals are qualified, then the biological performance and heavy metals of this batch of products are qualified. 7.4.2 Determination of qualified batches.
A batch is qualified if all items are qualified:
8 Marking, packaging, transportation and storagebzxz.net
8.1 Marking
The packaging of products shall comply with the provisions of GB/T191, including the quality certificate or label, and indicate the following contents: a) product name, specification, batch number, quantity; 5) manufacturer name;
c) production date, inspector code:
8.2 Packaging
-Use double corrugated paper boxes lined with plastic film for packaging or negotiated by the supply and demand parties: 8.3 Transportation
During transportation, mechanical collision or contact with sharp objects should be prevented, and loading and unloading should be done with care, and at the same time, avoid sun and rain to ensure that the packaging is intact and the product is not contaminated:
8.4 Storage
Products should be stored in a clean, hygienic, ventilated and light-proof warehouse, no less than 1m away from heat sources. 5
S/N:1580177-925
915801
792508
Packaging Industry Standard of the People's Republic of China
Co-extruded film for blister packaging of medical devices
BB/T0039—2012
Published by China Planning Publishing House
Website: jhpress.com
Address: Floor 1, Guohong Building, No. 11, Muqiang Yaobei Lijia, Xicheng District, Beijing Postal Code: 100038 Tel: (010) 639064 33 (Issuing Department) Xinhua 15 Store Beijing Issuing Office Issued
Sanhe Fuhua Printing and Packaging Co., Ltd. Printing 880mm×1230mm 1/16 0.75 Printing Sheet 18,000 Words 2012 1st Edition 2012%# Month 1st Edition☆
General—Book Number: 1580177·925
Pricing: 12.00 Yuan
Rights reserved
Submitted with newspaper phone: (010) 63906404 If there is any quality problem with the installed product, please send it to the publisher for replacement-69001 Cytotoxicity.
In accordance with the provisions of GB/T16886.5 in vitro cytotoxicity test. 6.6.2 Sensitization and skin irritation,
In accordance with the provisions of GR/T16886.10 irritation and hypersensitivity reaction test. 6.7 Heavy metals
Heavy metals shall be tested in accordance with the provisions of GB/T14233.1. 7 Inspection rules
7.1 Batch
The packaging film shall be inspected in batches. The same variety, same specification, same process, and same raw materials are continuously produced as a batch. The maximum batch of packaging film shall not exceed 1200 rolls. 7.2 Inspection classification
7.2.1 "Outgoing inspection".
The factory inspection items are the items specified in Table 2, Table 3, Table 4, Table 5, Table 6, Table 7, 7.2.2 Type inspection.
The inspection items are all the items specified in the requirements. Type inspection shall be carried out in any of the following cases: 4
a) When new products are trial-produced and identified;
b) When there are major changes in raw materials and processes that may affect product performance; c) When there is a major difference between the results of factory inspection and the type inspection; d) When the national quality supervision agency proposes the requirement for type inspection; 7.3 Sampling
BB/T 0059—2012
7.3.1 Appearance quality and dimensional deviation shall be sampled and inspected in accordance with the provisions of GB/T2828.1, using the normal inspection one-time sampling plan, the general inspection level 11, the acceptance quality limit AQL6.5, 7.3.2 Physical and mechanical properties and physical properties and heavy metal considerations shall be taken by random sampling method, and sufficient test specimens shall be drawn from each batch. 7.4 Judgment rules
7.4.1 Judgment of sample unit quality.
Take one roll as the sample unit, all items are qualified, and the sample unit is qualified: 7.4.1.1 Appearance quality and dimensional deviation If all items are qualified, the appearance quality and dimensional deviation of this batch of products are qualified. 7.4.1.2 Physical and mechanical properties meet the requirements of the standard, and the physical and mechanical properties of this batch are qualified. If there are unqualified items, double samples will be drawn from the batch to re-test the unqualified items. If all the re-test results are qualified, the batch is qualified. 7.4.1.3 Biological properties and heavy metals If all items are qualified, the biological properties and heavy metals of this batch of products are qualified. 7.4.2 Determination of qualified batches.
A batch is qualified if all items are qualified:
8 Marking, packaging, transportation and storage
8.1 Marking
The packaging of products shall comply with the provisions of GB/T191, including the quality certificate or label, and indicate the following contents: a) product name, specification, batch number, quantity; 5) manufacturer name;
c) production date, inspector code:
8.2 Packaging
-Use double corrugated paper boxes lined with plastic film for packaging or negotiated by the supply and demand parties:8.3 Transportation
During transportation, mechanical collision or contact with sharp objects should be prevented, and loading and unloading should be done with care, and at the same time, avoid sun and rain to ensure that the packaging is intact and the product is not contaminated:
8.4 Storage
Products should be stored in a clean, hygienic, ventilated and light-proof warehouse, no less than 1m away from heat sources. 5
S/N:1580177-925
915801
792508
Packaging Industry Standard of the People's Republic of China
Co-extruded film for blister packaging of medical devices
BB/T0039—2012
Published by China Planning Publishing House
Website: jhpress.com
Address: Floor 1, Guohong Building, No. 11, Muqiang Yaobei Lijia, Xicheng District, Beijing Postal Code: 100038 Tel: (010) 639064 33 (Issuing Department) Xinhua 15 Store Beijing Issuing Office Issued
Sanhe Fuhua Printing and Packaging Co., Ltd. Printing 880mm×1230mm 1/16 0.75 Printing Sheet 18,000 Words 2012 1st Edition 2012%# Month 1st Edition☆
General—Book Number: 1580177·925
Pricing: 12.00 Yuan
Rights reserved
Submitted with newspaper phone: (010) 63906404 If there is any quality problem with the installed product, please send it to the publisher for replacement-69001 Cytotoxicity.
In accordance with the provisions of GB/T16886.5 in vitro cytotoxicity test. 6.6.2 Sensitization and skin irritation,
In accordance with the provisions of GR/T16886.10 irritation and hypersensitivity reaction test. 6.7 Heavy metals
Heavy metals shall be tested in accordance with the provisions of GB/T14233.1. 7 Inspection rules
7.1 Batch
The packaging film shall be inspected in batches. The same variety, same specification, same process, and same raw materials are continuously produced as a batch. The maximum batch of packaging film shall not exceed 1200 rolls. 7.2 Inspection classification
7.2.1 "Outgoing inspection".
The factory inspection items are the items specified in Table 2, Table 3, Table 4, Table 5, Table 6, Table 7, 7.2.2 Type inspection.
The inspection items are all the items specified in the requirements. Type inspection shall be carried out in any of the following cases: 4
a) When new products are trial-produced and identified;
b) When there are major changes in raw materials and processes that may affect product performance; c) When there is a major difference between the results of factory inspection and the type inspection; d) When the national quality supervision agency proposes the requirement for type inspection; 7.3 Sampling
BB/T 0059—2012
7.3.1 Appearance quality and dimensional deviation shall be sampled and inspected in accordance with the provisions of GB/T2828.1, using the normal inspection one-time sampling plan, the general inspection level 11, the acceptance quality limit AQL6.5, 7.3.2 Physical and mechanical properties and physical properties and heavy metal considerations shall be taken by random sampling method, and sufficient test specimens shall be drawn from each batch. 7.4 Judgment rules
7.4.1 Judgment of sample unit quality.
Take one roll as the sample unit, all items are qualified, and the sample unit is qualified: 7.4.1.1 Appearance quality and dimensional deviation If all items are qualified, the appearance quality and dimensional deviation of this batch of products are qualified. 7.4.1.2 Physical and mechanical properties meet the requirements of the standard, and the physical and mechanical properties of this batch are qualified. If there are unqualified items, double samples will be drawn from the batch to re-test the unqualified items. If all the re-test results are qualified, the batch is qualified. 7.4.1.3 Biological properties and heavy metals If all items are qualified, the biological properties and heavy metals of this batch of products are qualified. 7.4.2 Determination of qualified batches.
A batch is qualified if all items are qualified:
8 Marking, packaging, transportation and storage
8.1 Marking
The packaging of products shall comply with the provisions of GB/T191, including the quality certificate or label, and indicate the following contents: a) product name, specification, batch number, quantity; 5) manufacturer name;
c) production date, inspector code:
8.2 Packaging
-Use double corrugated paper boxes lined with plastic film for packaging or negotiated by the supply and demand parties:8.3 Transportation
During transportation, mechanical collision or contact with sharp objects should be prevented, and loading and unloading should be done with care, and at the same time, avoid sun and rain to ensure that the packaging is intact and the product is not contaminated:
8.4 Storage
Products should be stored in a clean, hygienic, ventilated and light-proof warehouse, no less than 1m away from heat sources. 5
S/N:1580177-925
915801
792508
Packaging Industry Standard of the People's Republic of China
Co-extruded film for blister packaging of medical devices
BB/T0039—2012
Published by China Planning Publishing House
Website: jhpress.com
Address: Floor 1, Guohong Building, No. 11, Muqiang Yaobei Lijia, Xicheng District, Beijing Postal Code: 100038 Tel: (010) 639064 33 (Issuing Department) Xinhua 15 Store Beijing Issuing Office Issued
Sanhe Fuhua Printing and Packaging Co., Ltd. Printing 880mm×1230mm 1/16 0.75 Printing Sheet 18,000 Words 2012 1st Edition 2012%# Month 1st Edition☆
General—Book Number: 1580177·925
Pricing: 12.00 Yuan
Rights reserved
Submitted with newspaper phone: (010) 63906404 If there is any quality problem with the installed product, please send it to the publisher for replacement-6900
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