ISO 8317 Testing and Certification Services

Standard range:

ISO 8317:2015 specifies performance requirements and testing methods for reusable sealed packaging, which is designated to prevent children from opening.

When testing is conducted through a specified method, the acceptance criteria for packaging are provided. These methods not only provide indicators for measuring the effectiveness of packaging in limiting children's exposure, but also cover adult exposure to the contents.

ISO 8317:2015 applies to resealable packaging of any product that is exposed or removed from the packaging during normal use.

ISO 8317:2015 is only used for type approval and not for quality assurance purposes.

Standard Introduction:

ISO 8317 certification is an international standard published by the International Organization for Standardization (ISO), mainly aimed at testing and certifying the anti child opening performance of product packaging. This standard aims to ensure that product packaging can effectively prevent children from accidentally or accidentally opening, thereby protecting them from potential dangers and injuries. ISO 8317 certification mainly applies to products exported to the European Union, such as screw cap bottles, e-liquid bottles, ointment bottles, cosmetic bottles, and child safety bottles. These products require specific testing procedures, including testing for children and the elderly, to ensure that children cannot easily open the packaging while the elderly can use it conveniently. During the testing process, children need to try to open the packaging within a certain period of time. If no more than the specified proportion of children can successfully open it, it is considered that the packaging has sufficient protective ability for children. At the same time, the testing will also evaluate the usability of the packaging for the elderly, ensuring that they can correctly open and close the packaging. By obtaining ISO 8317 certification, companies can ensure that their product packaging complies with international child safety packaging testing standards, which helps reduce the risk of children ingesting, abusing drugs or other harmful substances, and protect children's health and safety. In addition, products that have obtained ISO 8317 certification are also more likely to gain recognition and acceptance in the international market, enhancing the competitiveness of enterprises.

Testing requirements:

According to the ISO 8317 standard, product packaging must use a child safety cover free (CRC), which is a packaging design that is difficult for children to open under specific conditions. This design requires the use of sturdy and durable materials, as well as a certain amount of strength and skill to open, to prevent children from accidentally coming into contact with the items inside the packaging. In addition, the packaging should be clearly labeled with "no child safety cover" or similar text to remind consumers to pay attention.

The testing methods of IS0 8317 include a series of methods for evaluating children's ability to prevent opening, such as child simulation tests, mandatory tests, and repeated tests. Through these tests, it is possible to evaluate whether the container meets the standards for preventing children from opening it, thereby ensuring the safety of the product.

The ISO 8317 standard is not only applicable to pharmaceutical packaging, but also gradually applied to other fields such as cosmetics, food, and body chemicals. It is of great significance in ensuring the safety of products and preventing children from accidentally ingesting harmful substances.

Please note that the specific ISO 8317 standard and related requirements may be updated or changed over time and industry development. Therefore, in practical applications, it is recommended to refer to the latest standard documents and relevant guidance.

Overall, the purpose of ISO 8317 standard is to prevent children from accidentally ingesting or coming into contact with substances that may be harmful to their health. This is a very important standard as it directly relates to the safety and health of children.

One The process and requirements for children's testing

1. Open every 5 minutes, with a total opening volume for both males and females at each age.

2. Open method.

3. The average opening time and standard deviation are tested every 5 minutes.

4. The percentage of software packages tested is the percentage of each site in the total package.

5. The percentage of each tester in the entire software package.

II Test requirement object:

(1) Request for age distribution of 200 children

30% of each group consists of 60 individuals aged between 42-44 months;

40% of each group consists of 80 individuals aged between 45-48 months;

30% of each group consists of 60 individuals aged between 49-51 months.

Children's age algorithm: those less than 15 days are counted as less than a month, and those 15 days or more are counted as one month.

Note: The ratio of male to female students in each age group is only 10%

(2) Requirement for 200 adult age distribution

30% of each group consists of 25 individuals aged between 50-54 years old;

40% of each group consists of 25 individuals aged between 55-59 years old;

30% of each group consists of 50 people aged between 60-70;

Gender ratio: 30%: 70%, with 17-18 females aged between 50-54.

III Test sample requirements:

300-400 samples are required for testing

4 Test cycle:

3-4 weeks of testing time

Shenzhen Element Testing Co., Ltd

Our company has obtained ANAB qualification recognition in the United States for preventing children from starting projects. The testing projects cover standards from various countries and regions, such as the International Organization for Standardization ISO, the European Union EN, the United States ASTM/FDA, Canada CSA/SOR, Germany DIN, the United Kingdom BS, the Gulf GSO, China GB, South Korea KS T, etc. Canada - CAN/CSA Z76.1; United States -16 CFR 1700.20&ASTM D3475; China - GB/T 25163-2010; Europe - EN 14375 (pharmaceuticals), EN 862 (non pharmaceuticals), EN ISO 8317, etc; International - ISO 8317.