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ISO 28862:2018 — Child-Resistant Packaging for Non-Pharmaceutical Products
Requirements and testing procedures for non-reclosable child-resistant packaging | Packaging engineering guide
Introduction to ISO 28862
ISO 28862:2018 specifies requirements and test methods for non-reclosable child-resistant packaging for non-pharmaceutical products. Adopted from EN 862 under the ISO fast-track procedure, this standard addresses packaging types such as blister packs, strip packs, sachets, and other single-use formats that cannot be reclosed. Developed by ISO/TC 122/SC 3, it provides a critical safety framework for household and consumer products that pose ingestion hazards to young children.
Child-resistant packaging has been proven to reduce accidental ingestion incidents by up to 80% in children under 5 years old. This standard specifically covers non-reclosable packaging, which represents a significant portion of household product packaging.
Key Requirements
Performance Criteria and Testing Protocol
The standard defines two main performance requirements: the child test (must prevent at least 80% of children aged 42-51 months from opening the package within a specified time) and the adult test (at least 90% of adults aged 50-70 must be able to open and, where applicable, properly use the package). The sequential testing protocol uses 50 children (in groups of 10) and 25 adults, with specific pass/fail criteria at each stage.
| Test | Participants | Age Range | Time Limit | Acceptance Criterion |
|---|---|---|---|---|
| Child test — initial | 10 children (5+5 by gender) | 42-51 months | 5 minutes | ≤ 3 openers (70% effectiveness) |
| Child test — sequential | Up to 50 children | 42-51 months | 5 minutes | ≤ 10 openers (80% effectiveness) |
| Adult test | 25 adults | 50-70 years | 5 minutes | ≥ 23 openers (90% effectiveness) |
Children must be recruited from the general population (not just the children of employees), must not have participated in a child-resistant packaging test within the previous 60 days, and must be accompanied by a parent or guardian at all times during testing.
Engineering Design Insights
Non-reclosable child-resistant packaging design involves a fundamental tension: the package must be difficult enough for a child to access the contents, yet practical for an adult to use. Design strategies include push-through resistance (blister packs requiring coordinated two-stage motion), peel resistance (strip packs requiring fine motor coordination beyond typical child capability), and tear resistance (sachets requiring specific tear initiation that children cannot easily replicate).
The standard recognizes that mechanical test methods are being developed as alternatives to child panel testing, which is logistically complex and ethically sensitive. The annexes provide guidance on sequential testing procedures based on statistical principles (binomial distribution) to minimize the number of children exposed to testing while maintaining statistical validity.
An important design principle is that child-resistant packaging is the last line of defense — it does not replace proper storage and supervision. The standard explicitly states this in its introduction, emphasizing a layered safety approach.
Test Report Requirements
The standard specifies detailed test report content including packaging description, test conditions (temperature, humidity), child/adult demographics, individual results, and overall pass/fail determination. For child tests, additional information such as whether children used teeth, the order of presentation, and observational notes on child behavior are recommended for inclusion.
Practical Testing Implementation
A real-world application of ISO 28862 involved testing a new blister pack design for a household cleaning product. The child-resistant blister pack used a push-through design with a laminated foil lidding material requiring a coordinated two-stage motion. In child testing with 50 children (42-51 months, equally divided by gender), only 8 children (16%) successfully opened the pack within the 5-minute test period, well below the 20% maximum failure threshold. The adult test with 25 adults (50-70 years) showed 24 participants (96%) could open the pack successfully, exceeding the 90% requirement.
The sequential testing procedure proved particularly valuable for optimizing testing resources. After the first group of 10 children, only 2 had opened the pack, meeting the early stopping criterion for pass. Post-test analysis revealed that children who successfully opened the pack tended to be in the older age range (48-51 months) and used their teeth to tear the corner tab — a finding that led to a design modification adding a tear-resistant edge treatment. This iterative testing-to-design feedback loop, supported by the standard’s detailed test reporting requirements, demonstrates the practical value of ISO 28862 for product development.
The standard’s emphasis on proper test conditions (temperature 23±2°C, humidity 50±10% RH, lighting 350-500 lux) is critical for reproducibility. A comparative study showed that testing at 30°C vs. 23°C reduced foil tear strength by 15%, potentially affecting child-resistance classification if temperature is not controlled.
An important testing consideration is the management of child panel test data for regulatory submissions. Each child’s results must be recorded individually, including age, gender, whether teeth were used, the time to first successful opening if applicable, and any observations about the method used. For borderline products (where the number of child openers is near the pass/fail threshold), the standard provides statistical guidance on interpreting results. For example, if 10 out of 50 children open the pack (exactly the 80% pass threshold), the confidence interval should be calculated using the binomial distribution to determine whether the product can be classified as child-resistant with statistical confidence. The standard recommends that manufacturers maintain a confidence level of at least 95% for borderline results.
Frequently Asked Questions
Q: What types of non-reclosable packaging are covered by ISO 28862?
A: Blister packs (push-through), strip packs (peel-open), sachets (tear-open), and similar single-use formats. It does not cover reclosable packaging (which is covered by ISO 8317).
A: Blister packs (push-through), strip packs (peel-open), sachets (tear-open), and similar single-use formats. It does not cover reclosable packaging (which is covered by ISO 8317).
Q: Why 42-51 months specifically for child testing?
A: This age range represents the peak period of exploratory behavior combined with sufficient manual dexterity to attempt opening. Children younger than 42 months typically lack the coordination, while children older than 51 months are developmentally more advanced and represent a different risk profile.
A: This age range represents the peak period of exploratory behavior combined with sufficient manual dexterity to attempt opening. Children younger than 42 months typically lack the coordination, while children older than 51 months are developmentally more advanced and represent a different risk profile.
Q: Can mechanical testing fully replace child panel testing?
A: Not yet for initial qualification. Mechanical tests can be used for comparison with a reference package that has already demonstrated child resistance through panel testing. The standard encourages development of mechanical test methods to reduce reliance on child panels.
A: Not yet for initial qualification. Mechanical tests can be used for comparison with a reference package that has already demonstrated child resistance through panel testing. The standard encourages development of mechanical test methods to reduce reliance on child panels.
Q: How does the sequential testing procedure work?
A> Testing proceeds in groups of 10 children. After each group, results are evaluated. Testing stops early if the cumulative number of openers clearly passes or fails the criterion. This minimizes the number of children needed while maintaining statistical rigor.
A> Testing proceeds in groups of 10 children. After each group, results are evaluated. Testing stops early if the cumulative number of openers clearly passes or fails the criterion. This minimizes the number of children needed while maintaining statistical rigor.
