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16 CFR 1700.20&16 CFR 1700.15 Testing and Certification Services

作者:超级管理员 发布时间:2024-07-29 14:08:17点击:111

Child protective packaging originated in the United States in 1970. The Toxic Substances Prevention Packaging Act (PPPA) stipulates that products harmful to children must use child safe packaging. A large number of accidents involving household, gardening, and automotive chemicals, as well as accidents involving drugs and other harmful substances, have triggered the legislative process. Subsequently, the frequency and severity of incidents involving child proof packaging have significantly decreased. The testing procedure for child safety packaging has been fixed according to the PPPA standard to ensure its functional reliability. In these tests, 200 children aged 42 to 51 months had to try opening a package. If 80% of people cannot complete this task, then this package can be considered resistant to children. However, equally important is that adults, especially the elderly, can also open and reinstall. Many other countries have also followed the US example published in 16 CFR § 1700.20 of the US Federal Code and developed similar standards.

Application materials required for testing of A 16 CFR 1700.20:

1. Application form;

2. Certified product information (including product pictures, product drawings, volume and other parameter descriptions);

3. Ensure at least 405 test samples.

B 16 CFR 1700.20 testing requirements:

(1) Children's group

① Composition of the experimental group:

(a) Number of people: 200 children;

(b) Age and gender: Age between 42-51 months (including 42 months and 51 months, the following age and gender should be evenly distributed);

(c) To represent as much as possible the different social classes, races, and cultural backgrounds of the entire population of the country;

(d) Physically healthy, without obvious physiological and intellectual defects, and with certain hands-on abilities;

(e) The number of times to participate in this experiment shall not exceed one (including various open type packaging tests based on different principles). If a child is allowed to participate in more than one experiment, the interval between the two experiments should be at least one week.

② Preventing children from opening packaging for testing location:

The experiment should be conducted in a familiar location for children, such as the school or kindergarten they attend, but the experimental children should be separated from other school personnel and avoid external interference. Several locations should be selected from areas with different population distributions, and the experiment may not be completed at the same location or time.

③ Test method:

(a) Children's experiments should be conducted in pairs, each under the supervision of an impartial, qualified, and skilled person who is skilled in dealing with children. If necessary, 5 pairs of children can be arranged for testing in the same room without interfering with each other. They can adopt the posture and position they deem convenient. During the experiment, if a child wants to slip away, the supervisor should stop them; And induce the child to return to their position, asking them to continue, but without giving any prompts to open the packaging. This situation should be recorded in the test report;

(b) Within the first 5 minutes, prior to the demonstration, distribute the packaging to each child who can open it using any method they wish. Do not prevent children from using teeth or other methods to open the packaging. Except for tools or devices specifically provided as part of child safety packaging, children are not allowed to use any other tools or appliances. In this case, if children are not aware of which tool can be used, they do not need to be reminded until the demonstration;

If a child successfully opens the package within 5 minutes, the child should remain in their testing area until the end of that time period;

(c) Before the start of the second 5-minute period, allow children who have not opened the packaging within the first 5-minute period to watch the supervisor open and seal a package, without focusing on the opening action or any verbal prompts, and then give these children another 5-minute period to open the package;

(d) After each 5-minute period, it should be recorded whether a child has opened the packaging. If the child successfully opened the packaging, it should be recorded whether it was before or after the demonstration. Also record whether the packaging was opened using teeth or other methods.

④ Determination of the results of the children's group experiment:

(a) Without demonstration, at least 85% of the children in the experimental group were unable to open the bag within 5 minutes;

(b) After demonstrating to those children who did not open the packaging within the first 5 minutes, 80% of the children were still unable to open the packaging within the second 5 minutes.

(2) Elderly group

① Composition of the experimental group:

(a) Number of people: 100 normal elderly individuals;

(b) Age and gender: Women should account for 70%, with 25 people aged 50-54 (including 50 and 54 years old, the same below); 25 people aged 55-59 and 50 people aged 60-70.

② Test method:

Send the packaging along with other accessories and instructions on how to open and reseal the packaging correctly (the contents of which are printed on or provided to consumers inside the packaging) to each elderly person, without demonstrating how to open and reseal the packaging. Allow 5 minutes for each adult to read the instructions, open the packaging and reseal it correctly, and record the results.

③ Judgment of the results of the elderly group experiment: Without demonstration, at least 90% of the elderly can correctly open and reseal the packaging within 5 minutes.

Appendix 1-16 CFR 1700.15 Chinese Version

§ 1700.15 Anti toxic Packaging Standards.

The Committee has determined that packaging designed and constructed to meet the following standards shall be considered as "special packaging" within the meaning of Article 2 (4) of the Convention, in order to protect children from serious personal injury or illness caused by the handling, use or ingestion of household food. These standards require special packaging that complies with the provisions of § 1700.14 for the specific application of substances.

(a) General requirements. Special packaging must continue to operate under the effectiveness specifications set forth in Article 4 (b), including the substances contained therein when in actual contact. This requirement can be met by conducting appropriate scientific evaluations of compatibility, determining the chemical with special packaging, and ensuring that the physical properties of the substance do not compromise or interfere with the normal operation of the special packaging. Special packaging must also continue to comply with the validity specifications specified in paragraph (b) of this article for its usual opening and closing times, size, and content. This requirement can be met through appropriate means based on technical evaluation of physical wear and stress factors, activation of required forces, and other related factors to determine that during normal use, it is expected that the effectiveness specifications of the packaging will not be predicted to reduce.

(b) Validity specifications. Special packaging, tested according to the method described in Section 1700.20, should meet the following specifications:

(1) Children's resistance is not less than 85% without demonstration, and demonstrate the correct method of opening packaging for such special products. In the case of unit packaging, the child safety effectiveness is not less than 80%.

(2) Convenience for adults to open - (i) Elderly - Adult testing. Except for the products specified in item (b) (2) (ii) of this paragraph, the special packaging in Section 2 shall have a panel test with an effectiveness for elderly use (SAUE) of not less than 90% in accordance with § 1700.20 (a) (3).

(ii) Adolescent testing - (A) if applicable. Goods that must be in the form of aerosols and require metal containers to have an effectiveness of not less than 90% for testing on young adults according to the following standards. The elderly group test in § 1700.20 (a) (3) is indeed not applicable to these products. For the purpose of this paragraph, metal containers refer to containers that have both metal packaging and reusable sealing. Metal sealing and aerosol products are independent pressurized products.

(B) Determine whether metal or aerosol containers are required - (1) standard. The product will be considered to only form metal containers or aerosols in the following situations:

(i) There are no other packaging types that comply with regulations or federal laws in other countries,

(ii) No other packaging can be reasonably used for the intended application of the product,

(iii) No other packaging or sealing materials are compatible with the substance,

(iv) There are no other suitable packaging types that can provide sufficient shelf life for the intended use of the product, or

(v) Any other reason clearly indicates that such packaging is necessary.

(2) Inference. In the absence of convincing evidence to the contrary, it should be presumed that the product does not require the same composition as the metal container if it is a product or other product, and has previously been sold in packaging using non-metallic packaging or non-metallic sealing.

(3) Reason. Manufacturers or packers who claim that they do not need to comply with the SAUE requirements of § 1700.20 (a) (3) for products packaged in metal containers or aerosol form should provide written explanations if requested by committee staff, stating the reason why the product must have a metal container or aerosol. Manufacturers and packaging companies who wish to voluntarily do so can submit reasons to the European Commission Compliance Office stating that their products must be packaged in metal containers or aerosols. If such a situation arises, the staff will respond to the manufacturer or packaging company's request, explaining the reasons for the staff's response.

(c) Reuse of special packaging. Substances subject to this provision shall not be reused for special packaging.

(d) Restricting mobility. Special packaging shall be subject to the provisions of this paragraph, and the flow of special packaging liquids shall be so restricted that no more than 2 milliliters of content can be obtained when inverted, and the opened container shall be removed or squeezed once, or activated once when the container is removed or squeezed otherwise.

(Sections 2 (4), 3, 5, 84, 1670-72 of the United States Code; Title 15, Sections 1471 (4), 1472, 1474 of the United States Code [38 FR 212471, August 7, 1973, revised at 60 FR 37734, July 21, 1995]

Appendix 2-16 CFR 1700.20 Chinese Version (Partial)

1700.20 Testing program for special packaging.

(One) Testing Protocol -

(1) General requirements -

Packaging requirements. According to the provisions of § 1700.15 (b), special packaging is required to meet the child testing requirements and applicable adult testing requirements of this § 1700.20.

(Second) Packaging condition to be tested -

(One) Anti tampering function. Any tamper proof function of the packaging to be tested should be removed before testing, unless it is part of the packaging's child safety design. If the packaging provided to consumers is packaged in an outer packaging that does not belong to the child safety design of the packaging, one of the following situations applies:

(1) In the sub test, remove the package from the outer packaging and do not hand over the outer packaging to the child.

(2) In these two adult tests, if there are instructions on how to open or properly reposition the packaging on the outer packaging, the packaging should be placed inside the outer packaging and handed over to the test subject. The time required to remove the package from the outer packaging is not included in the allowed time for attempting to open and (if applicable) re close the package.

(3) In these two adult tests, if there are no instructions related to the test on the outer packaging, the packaging will be removed from the outer packaging and will not be handed over to the test subject.

(B) Reusable Closed Packaging - Adult Testing. In these two adult tests, if assembled by the testing agency, the resealable packaging should be properly secured at least 72 hours before the start of the test to allow materials (such as sealing pads) to "take one set". If assembled by a testing agency, the closure components related to torque should be fixed with the same conductive torque applied on the packaging line. The applied torque must be recorded in the test report. All packaging should be handled to ensure that there is no damage or vibration during storage or transportation. The packaging must not be exposed to extreme high or low temperature conditions. The packaging should be tested at room temperature.

(2) Children's Testing -

(I) Test Object -

(One) inclusion and exclusion criteria. According to the requirements of the sequential testing standards in Table 1, use groups 1 to 4, with 50 children in each group. No more than 20% of children in each group shall undergo testing at any specific location or obtain testing from any given location. Each group of children should be randomly selected based on their age, but must comply with the following restrictions. 30% of the children in each group are aged 42-44 months, 40% of the children in each group are aged 45-48 months, and 30% of the children in each group are aged 49-51 months. The age of a child should be calculated as follows:

(1) Arrange the date of birth and exam date by numerical names of month, day, and year (e.g. exam date: August 3, 1990; date of birth: June 23, 1986).

(2) Subtract the month, day, and year of birth from the corresponding number on the exam date. This may result in negative months or days. For example,

(3) Multiply the annual difference by 12 to obtain the number of months in the annual difference, and add this value to the number of months obtained by subtracting the date of birth from the test date (i.e. 4 × 12=48; 48+2=50). This number either remains unchanged or is adjusted up or down by one month, depending on the number of days obtained by subtracting the date of birth from the exam date.

(4) If the number of days obtained by subtracting the number of days of the date of birth from the number of days of the test date is+16 or more, then add 1 month to the number of months obtained above. If the number of days is -16 or less, subtract 1 month. If the number of days is between -15 and+15 (inclusive), the number of months will not change. Therefore, for the example given above, the number of days is -20, so the number of months is 50-1=49 months.

(B) Gender distribution. The difference between the number of boys and girls in each age group shall not exceed 10% of the number of children in that age group. The selected children should not have obvious or noticeable physical or mental disorders. Each child's parents or guardians should read and sign a consent form before the child participates. The committee staff will not ignore the test results conducted by other parties simply because they did not obtain the informed consent of the child.

(Second) Test failed. Test failure should be attributed to any child who opens special packaging or comes into contact with its contents. However, in the case of unit packaging, test failure should be due to any child opening or obtaining a quantity of individual units that could result in serious personal injury or serious illness, or opening or obtaining more than 8 individual units, whichever is lower, during a full 10 minute test. The number of products opened or accessed by children is interpreted as individual products that have been or can be completely or partially removed. The determination of the amount of substances that may cause serious personal injury or serious illness should be based on a child weighing 25 pounds (11.4 kilograms). Manufacturers or packers who intend to use unit packaging for substances that require special packaging are required to submit such toxicological data to the Committee Compliance Office.

(Third) Sequential testing. The sequential test was initially conducted on 50 children, and based on the results, the standards in Table 1 were used to determine whether the packaging was suitable for children or whether further testing was needed. If the results are uncertain and involve the use of one or more additional groups of 50 children per group, up to a maximum of 200 children, further examination is required. No individual is allowed to test more than 30% of the tested children in each group. Table 1 presents the acceptance (pass), continuation (continue), and rejection (fail) criteria used during the first 5 minutes and the entire 10 minutes of the children's test. If the testing continues beyond the initial 50 sub panels, the packaging openings shown in Table 1 are cumulative.

Table 1- Number of openings: Acceptance (pass), continuation (continue), and rejection (fail) criteria for the first 5 minutes and complete 10 minutes of child protocol testing (omitted)

(4) Test program. Children should be divided into pairs. Testing should be conducted in a familiar location for children, such as their preferred daycare or regular kindergarten. No child is allowed to test two or more special packages. When testing multiple special packages, each package should have a different ASTM type and should be presented in random order to paired children. This order should be recorded on file. Children should be tested according to the procedures included in the following test instructions:

Standardized Child Testing Instructions

If assembled by a testing agency, the resealable packaging should be properly secured at least 72 hours prior to the opening as described in Directive 3, to ensure that the material (e.g. closure liner) is "complete". The applied torque must be recorded in the test report.

2. The handling of all packaging should ensure that no damage or vibration occurs during storage or transportation. The packaging must not be exposed to extreme high or low temperature conditions. The packaging should be tested at room temperature.

3. Re sealable packaging should be opened and properly re secured once (or multiple times as appropriate) by a testing agency or other adult before testing. Do not open or re fix in the presence of children. In adult re fixation testing, testers are not allowed to open and re fix packaging before testing. If multiple openings/re fixations are to be used, each of the four (4) testers should open and correctly re fix a quarter of the packaging once, and then open and correctly re fix each packaging from the second, third, fourth to tenth (or other specified quantity) times, in the same order as the first opening and re fixing. Before testing, the packaging must not be opened or re secured again. The name of each tester and the package number they opened and re secured should be recorded and reported. Testers do not need to perform protocol testing on the packages they open and re protect.

4. Children shall not have obvious physical or mental defects. Any child who suffers from permanent or temporary illness, injury, or disability that may interfere with their effective participation should not be included in the test.

5. The test should be conducted in a place that is familiar to children and has sufficient light without any interference.

6. Examiners or other adults should accompany a pair of children to the examination area. The tester should have two children seated so that there are no visual impairments between them and the tester.

7. Testers should talk to children to make them feel at ease.

8. Do not give children the impression that they are participating in a competition or competition. They should not be told that testing is a game or that it is fun. Do not provide them with rewards.

Testers should record all data before or after the test so that children can be fully monitored during the testing period.

10. Testers should use a stopwatch or other timing device to calculate the number of seconds required for children to open the packaging and time the 5-minute testing cycle.

When starting the test, the tester should hand the same packaging to the children and say, 'Please try opening this for me.'.

If a child refuses to participate after the test begins, the tester should comfort the child and gently encourage them to try. If the child continues to refuse, the tester should ask the child to place the package on their lap until another child completes it. Unless the rejected child interferes with another child's participation, the child cannot be eliminated from the outcome.

Each child has a maximum of 5 minutes to open their package. During the testing process, the tester should always monitor the child. As long as children continue to try to open the packaging, testers should try to minimize conversations with them. Testers shall not use verbal or facial expressions to dissuade children. If a child feels frustrated or bored and stops trying to open their package, the tester should comfort the child and gently encourage them to continue trying (e.g. "Please try opening the package").

14. As long as the experimenter can observe two children (for example, they can stand up, fall to the floor, or knock or pry open the package), the children should be allowed to freely move and work on the package.

If a child endangers themselves or others at any time, the test should be stopped and the child should be excluded from the final results.

16. Children should be allowed to talk to each other about opening packages, and they should be allowed to watch each other try to open packages.

17. Do not allow one child to attempt to open another child's package.

If a child opens his/her package, the tester should say "thank you", take the package from the child's hand, and place it out of their reach. Children are not allowed to open the packaging again.

At the end of 5 minutes, the tester should demonstrate how to open the package if any child fails to do so. The demonstration should use a separate 'demonstration' package.

Before starting the demonstration, the tester should ask the children to put their packages aside. During the demonstration period, children are not allowed to continue attempting to open their packages.

21. The tester should say, 'Watch me open my package.'.

Once the tester pays full attention to the child, the tester should place the demonstration package about two feet away from the child and open the package at a normal speed, as if the tester were using the contents. There must be no exaggerated opening movements.

Testers are not allowed to discuss or describe how to open the packaging.

To begin the second 5-minute cycle, the tester should say, 'Now you are trying to open your package.'.

If one or two children have not attempted to open the package with their teeth within the first 5 minutes, the tester should immediately say, 'If you wish, you may use your teeth.' This is the only statement that the tester should make regarding the use of teeth.

The test should continue for another 5 minutes or until both children open the package, whichever comes first.

At the end of the testing period, the tester should say, "Thank you for your help. If the child is told that they can use their teeth, the tester should say, 'I know I told you that you can use your teeth today, but you shouldn't put something like this in your mouth again.' In addition, the tester should say, 'When you're alone, never open this packaging. There may be something in this packaging that could make you sick.'.

28. Children should be escorted back to the classroom or other supervised area by a tester or other adult.

If children are to participate in the second test, the tester should have them stand up and stretch for a short period of time before starting the second test. Testers should be careful not to let children interfere with other ongoing tests.

(3) Elderly Group -

I am the test subject. Use a group of 100 elderly people. No more than 24% of elderly individuals who undergo testing shall come from any location or be tested at any location. Each group of elderly people should be randomly selected based on their age, but must comply with the following restrictions. 25% of the participants are aged between 50-54, 25% are aged between 55-59, and 50% are aged between 60-70. 70% of participants aged 50-59 and 60-70 are females (17 or 18 females should be assigned to the 50-54 age group). No individual tester shall test more than 35% of the elderly individuals who have undergone testing. The selected adult should not have obvious or significant physical or mental disabilities.

(Second) Screening program. Participants who are unable to open the packaging being tested within the first 5 minutes will undergo a screening test. The screening test used for this purpose should use two packages with traditional (non child safe (CR) or "special") sealing. One seal should be a plastic buckle seal, and the other should be a CT plastic seal. The diameter of each closure should be 28 mm ± 18%, and the CT closure should be re secured 72 hours before testing with a torque of 10 inch pounds. Both snap on and CT type sealed containers should be circular plastic containers with a size of 2 ounces ± 1 ⁄ 2 ounces for CT type sealed containers and 8 drams ± 4 drams for snap on sealed containers. Individuals who are unable to open or close two screening packages during a 1-minute screening test will not be counted as participants in the elderly group.

(Third) SAUE. The Elderly Use Efficiency (SAUE) is the percentage of adults who open the packaging during the first (5-minute) test period and correctly re secure the packaging during the 1-minute test period (if applicable).

(4) Test program. Elderly individuals should undergo testing individually, rather than in groups of two or more people. Older people should only receive printed instructions on how to open and properly secure special packaging, which will appear on or accompanying the packaging when it is delivered to consumers. The elderly group will conduct the test according to the procedures included in the following elderly group testing instructions:

Exam instructions for advanced exams

The following test instructions are for all advanced tests. If testing a package that cannot be closed again, the command to close the package will be eliminated.

1. Any adult who suffers from permanent or temporary illness, injury or disability shall not participate in the examination, as these illnesses, injuries or disabilities may hinder his/her effective participation.

2. Each adult should read and sign a consent form before participating. Potential participants can be recruited using any appropriate language in the consent form. This form should include the basic elements of informed consent as defined in 16 CFR 1028.116. An example of the form used by committee staff for testing is provided in § 1700.20 (d). Before starting the test, the tester should say: "Please read and sign this consent form. If an adult is unable to read the consent form for any reason (forgetting to wear glasses, illiteracy, etc.), he/she shall not participate in the test.

3. Each adult is not allowed to participate alone in the presence of other participants or bystanders.

4. The test should be conducted in a well lit and interference free location.

5. Records should be filled out before or after the exam, so that the candidate's full attention is focused on them during the exam period. The only exception is to record the testing time for opening and re securing the packaging.

At the beginning of the first 5-minute testing phase, the tester said, "I will ask you to open and correctly close these two identical packages according to the instructions on the lid. (If applicable, please specify other instruction positions.).

7. The tester hands over the first package to the participant, who says, 'Please open this package according to the instructions on the bottle cap.' (If applicable, please specify another instruction location. If the package contains products, the tester should say, 'Please empty (pills, tablets, contents, etc.) and place them in this container.' After the participant opens the package, the tester says, 'Please close the package correctly according to the instructions on the bottle cap.' (If applicable, please specify another instruction location.)

Participants have a maximum of 5 minutes to read the instructions and open and close the packaging. The tester uses a stopwatch or other timing device to start and reset the time. The time taken to open and close the packaging (in seconds) is recorded as two separate times in the data manual.

After 5 minutes, or when the participant opens and closes the packaging, whichever comes first, the tester should take all test materials from the participant's hands. If participants initiate these actions, they can remove and replace the closure multiple times. If the participant does not open the package and stops trying to open it before the end of 5 minutes, the tester should say: "Have you finished using that package or do you want to try again? If the participant indicates that he/she has completed or is unable to open the package and does not want to continue trying, please skip to instruction 13.

10. At the beginning of the second testing phase, the tester should give the participant another but identical package and say, 'This is an identical package. Please open it according to the instructions on the bottle cap.' (If applicable, please specify another instruction location. If the package contains products, the tester should say, 'Please empty (pills, tablets, contents, etc.) and place them in this container.' After the participant opens the package, the tester says, 'Please close the package correctly according to the instructions on the bottle cap.' (If applicable, please specify another instruction location.).

Participants are allowed a maximum of 1 minute (60 full seconds) to open and close the packaging. The time taken to open and close the packaging (in seconds) is recorded as two separate times in the data manual. The time elapsed between the instruction to open and close the packaging is not included in the 1-minute testing time.

12. After the 1-minute test, or when the participant opens and closes the packaging, whichever comes first, the tester should take all test materials from the participant's hands. Participants are not allowed to handle the package again. If the participant does not open the package and stops trying to open it before the end of 1 minute, the tester should say, 'Have you used up that package or do you want to try again?' If the participant indicates that he/she has completed or is unable to open the package and does not want to continue trying, the 1-minute test should be considered a failure.

Participants who did not open their packages during the first 5 minutes of the test were asked to open and close two non child safety screening packages. Participants have a 1-minute testing period for each package. The tester should give the participant a package and say, 'Please open and close this package correctly.' The tester should record the time of opening and closing on the data sheet, or 61 seconds, whichever is shorter. Then, the tester should hand over the second package to the participant and say, 'Please open and close this package correctly.' The time of opening and re securing, or 61 seconds, whichever is shorter, should be recorded on the data sheet.

Participants who are unable to open and re secure two non child safety screening packages will not be included in the group of 100 elderly individuals. Select and test other participants.

15. Any adult should participate in two or more tests at a time. If a person participates in two tests, the packaging for the tests must not be of the same ASTM type.

If the number of adults in a certain gender or age group who undergo testing exceeds the number required to determine SAUE, the last person to undergo testing should be removed from that group.

(4) Youth group.

100 adults aged between 18 and 45 without obvious physical or mental disabilities, 70% of whom are females, should form a young person testing group. No more than 35% of adults shall be obtained or tested at any one location. No individual tester is allowed to test more than 35% of the tested adults. Conduct individual testing for adults, rather than testing in groups of two or more individuals. Adults should only receive printed instructions on how to open and properly reposition special packaging, which will appear on the packaging when it is delivered to consumers. Five minutes should be set aside to complete the opening ceremony, and the re fixation process should be completed at an appropriate time.

(2) The number of adults who were unable to open and the number of other adults who were tested and failed to properly reposition the special packaging should be recorded. The percentage of adults who successfully open the special packaging and then correctly re fix it (if appropriate) is the effectiveness of adult use of the special packaging. In the case of unit packaging, the percentage of effectiveness for adult use should be the number of adults who successfully open a single (unit) packaging.

(b) As a standard issued by regulations, it aims to designate specific substances as subject to special packaging requirements under the Act, specifying the percentage of child resistance effectiveness and adult use effectiveness required for each substance, and, where appropriate, including any other conditions deemed necessary and specified in the Act.

(c) It is recommended that manufacturers of special packaging or producers of substances subject to regulations issued under this law submit to the committee a summary of data generated from tests conducted in accordance with this protocol.

(d) Suggestion. The following instructions and procedures, although not necessary, have been adopted by the committee staff and are recommended for use in appropriate circumstances.

(1) Report format for sub tests.

A. Proof of Identity

1. Take close-up color photos to clearly identify the packaging and display opening instructions on the seal.

2. Product name and quantity of tablets or capsules in the packaging.

3. Product manufacturer.

4. Closed model (product name - e.g. "KLIK&SNAP").

5. Bottle cap size (e.g. 28 millimeters).

6. Bottle cap manufacturer.

7. Bottle cap material and color (e.g. white polypropylene).

8. Bottle cap liner material.

9. TAC sealing material.

10. Open the instructions (accurately quote, for example, "when pushing, downward, or turning right"). Commas are used to separate words on different rows.

11. Symbols, numbers, and letters found inside the seal.

12. Packaging model.

13. Packaging materials and colors.

14. Net content.

15. Symbols, numbers, and letters at the bottom of the packaging.

16. Other product identification, such as EPA registration number.

B. Program

1. Describe all the processes involved in preparing the test package.

2. Describe the testing program.

3. Describe all instructions given to the child.

4. Define a single package failure.

C. Result

1. The number of openings per 5-minute time slot and the total number of openings for males and females in each age group.

2. Opening method (such as normal opening, teeth, etc.).

3. The average open time and standard deviation for each 5-minute testing cycle.

4. The percentage of packages tested at each site compared to the total packages.

5. The percentage of packaging tested by each tester to the total packaging.

6. Child safety performance in the first 5 minutes and throughout the entire testing period.

(2) Standardized adult re safety testing instructions. The US Consumer Product Safety Commission (CPSC) will use adult re fixation testing when it cannot objectively determine (e.g., visually or mechanically) that the package has been properly re secured. The adult re fixation test shall be conducted in the following manner:

Adult re fixation program

After adult participants in the Elderly Adult Test under 16 CFR 1700.20 (a) (3) or the Adolescent Test under 16 CFR 1700.20 (a) (4) have secured their packages again, or at the end of the testing period (whichever comes first), the tester should keep the packages out of reach. Adult participants are not allowed to handle the package again.

2. For packages that have been opened and appear to have been re secured by adults, children should be tested according to a child testing procedure to determine if the package has been properly re secured. These packages are intended for children and have not been opened or re secured for any purpose.

3. Based on the results of adult testing and children's testing of clearly re fixed packaging, the calculation method for the effectiveness of adult use is as follows:

a. Adult use effect.

1. The number of failed attempts by adults to open and re fix, plus 20% of the packages opened by children during the full 10 minute test that exceeded those clearly re fixed, equals the total number of failures.

2. The total number of packaging for adult testing (i.e. 100) minus the total number of failures equals the percentage of effectiveness for adult use.

(3) Report format for adult re safety testing.

A. Proof of Identity

1. Take a close-up color photo to clearly identify the packaging and display the top of the seal.

2. Product name and quantity of tablets or capsules in the packaging.

3. Product manufacturer.

4. Closed model (product name).

5. Bottle cap size (e.g. 28 millimeters).

6. Bottle cap manufacturer.

7. Bottle cap material and color (e.g. white polypropylene)

8. Bottle cap liner material.

9. Symbols, numbers, and letters found inside the seal.

10. TAC sealing material.

11. Open the instructions (accurately quote, for example, "when pushing, downward, or turning right"). Commas are used to separate words on different rows.

12. Packaging model.

13. Packaging materials and colors.

14. Net content.

15. Symbols, numbers, and letters at the bottom of the packaging.

16. Other product identification, such as EPA registration number.

B. Program

1. Describe all the processes involved in preparing the test package.

2. Provide a detailed description of the testing program.

3. Describe all instructions given to participants.

4. Define individual package failures and determine the process of failure.

C. Result

Adult testing

1. The total number of opened packages and the total number of re secured packages; Packages opened by both men and women; And packages that are re secured by both males and females.

2. The average opening time and standard deviation of total opening times, female total opening times, and male total opening times.

3. The average time and standard deviation of total re fixation times, female total re fixation times, and male total re fixation times.

4. The percentage of packages tested at each site compared to the total packages.

5. The percentage of packaging tested by each tester to the total packaging.

6. Opening method (such as normal opening, pry switch closing, etc.)

Children's testing

1. The number of openings per 5 minutes for males and females in each age group, as well as the total number of openings.

2. Opening method.

3. The average open time and standard deviation for each 5-minute testing cycle.

4. The percentage of packages tested at each site compared to the total packages.

5. The percentage of packaging tested by each tester to the total packaging.

(4) Consent form. The committee used the following consent forms for elderly adult testing, sealable and unit dose packaging.

1. Reusable sealed packaging.

[Letter header of testing agency]

Child safety packaging testing

The U.S. Consumer Product Safety Commission is responsible for testing child safety packaging to ensure that they can protect young children from harm caused by drugs and dangerous household products. With the help of people like you, manufacturers are able to improve the packaging we use, making the contents child safe but easier for the rest of us to open.

Since the passing of the Poison Prevention Act in 1970, effective child protective packaging has prevented thousands of poisoning incidents. Since 1974, the use of child safe packaging on prescription drugs alone may have saved the lives of over 350 children.

As part of this program, we are testing a child safety packaging to determine if adults aged 50 to 70 can open and close it correctly. You may or may not be familiar with the software package we are testing. Take it slow, please don't feel like you're undergoing testing - we're testing the packaging, not you.

Test instructions

1. I will give you a package. Please read the instructions, open and close the package correctly.

Then I will give you the same package and ask you to open and close it correctly.

3. I may ask you to open some other types of software packages.

4. The packaging may be empty or may contain the product.

5. I will ask you, do you think child safety packaging is easy or difficult to use.

Consent Form for Child Safety Packaging Testing

The Consumer Product Safety Commission in the United States has been using contractors to test child safety packaging for many years, and although it may cause minor injuries, it will not harm anyone.

I agree to test the child safety package. I know I can change my mind at any time. My age is between 50 and 70 years old (inclusive).

birthday

autograph

date

Postal Code

Office use

Website:

Sample Number:

Test Number:

Product number in the package:

2. Unit dose packaging.

[Letter header of testing agency]

Unit dose resistance packaging test for children

The U.S. Consumer Product Safety Commission is responsible for testing child safety packaging to ensure that they can protect young children from harm caused by drugs and dangerous household products. With the help of people like you, manufacturers are able to improve the packaging we use, making the contents child safe but easier for the rest of us to open.

Since the passing of the Poison Prevention Act in 1970, effective child protective packaging has prevented thousands of poisoning incidents.

Since 1974, the use of child safe packaging on prescription drugs alone may have saved the lives of over 350 children.

As part of this program, we are testing a child safe packaging to determine if adults aged 50 to 70 can open it. You may or may not be familiar with the software package we are testing. Take it slow, please don't feel like you're undergoing testing - we're testing the packaging, not you.

Test instructions

1. I will give you a package. Please read the instructions, open a unit, and then take out the contents inside.

Then I will give you the same packaging and ask you to open a unit and take out the contents inside.

3. I may ask you to open some other types of software packages.

I will ask you, do you think the child safety bag is easy to use or difficult to use.

Consent Form for Child Safety Packaging Testing

The Consumer Product Safety Commission in the United States has been using contractors to test child safety packaging for many years, and although it may cause minor injuries, it will not harm anyone.

I agree to test the child safety package. I know I can change my mind at any time. My age is between 50 and 70 years old (inclusive).

birthday

autograph

date

Postal Code

Office use

Website:

Sample Number:

Test Number:

Product number in the package:

[38 FR 21247, August 7, 1973, revised on July 22, 1995 at 60 FR 37735 and 37738]