Testing Standards for Child-Resistant Sealing

 Child-resistant (CR) packaging is essential for preventing accidental ingestion of hazardous substances by children while ensuring accessibility for adults. To guarantee effectiveness, child-resistant sealing must comply with stringent testing standards set by regulatory bodies worldwide. These standards define testing procedures, performance requirements, and certification protocols.

---

1. International and National Standards for Child-Resistant Sealing

A. ISO 8317 – International Standard for Reclosable Packaging

• Applies to reclosable child-resistant packaging for pharmaceuticals, chemicals, and household products.
• Requires testing with children (42–51 months old) and adults (50–70 years old) to evaluate usability.
• The packaging must prevent at least 85% of children from opening it within 5 minutes and at least 80% after a second attempt with instructions.
• At least 90% of adults must be able to open and properly reclose the package within a set time.

B. 16 CFR 1700.20 – U.S. Consumer Product Safety Commission (CPSC) Standard

• Regulates child-resistant packaging for pharmaceuticals, household chemicals, and pesticides in the U.S.
• Similar to ISO 8317, testing involves panels of children (42–51 months old) and adults (50–70 years old).
• At least 80% of children must be unable to access the package within 10 minutes, and 90% of adults must be able to open it within 5 minutes.

C. EN 14375 – European Standard for Non-Reclosable Packaging

• Applies to non-reclosable child-resistant packaging, such as blister packs and strip packs for pharmaceuticals.
• Requires the same child and adult panel testing as ISO 8317.

D. EN 862 – European Standard for Non-Pharmaceutical Consumer Goods

• Covers child-resistant packaging for household products (e.g., cleaning chemicals, pesticides).
• Uses a similar testing methodology as other child-resistant packaging standards.

E. ASTM D3475 – U.S. Standard Classification for Child-Resistant Packaging

• Classifies child-resistant packaging based on materials, design, and performance criteria.
• Often used in conjunction with 16 CFR 1700.20 for compliance in the U.S.

F. CAN/CSA-Z76.1 – Canadian Standard for Reclosable CR Packaging

• Similar to ISO 8317 and 16 CFR 1700.20 but adapted for Canadian regulations.
• Ensures compliance with Canadian Consumer Product Safety Act (CCPSA).

---

2. Testing Methods for Child-Resistant Sealing

A. Child Testing Panel (CR Effectiveness Test)

• Conducted with 50-200 children aged 42–51 months.
• Children are given 5 minutes to open the package without instructions.
• If unsuccessful, a demonstration is given, and they are allowed another 5 minutes.
• The package fails if more than 20% of children open it.

B. Adult Testing Panel (Senior Use Effectiveness Test)

• Conducted with 100 adults aged 50–70 years.
• Measures the ability to open and properly reclose the package within a set time.
• At least 90% of adults must succeed for the package to pass.

C. Torque and Force Testing

• Used for bottle caps, closures, and snap-fit seals.
• Measures the force or torque required to open the package to ensure it is too difficult for children but accessible for adults.

D. Tamper Evidence & Seal Integrity Test

• Ensures that any tampering or attempt to open the package is clearly visible.
• Common for blister packs and pharmaceutical packaging.

---

3. Regulatory Compliance and Certification

• Manufacturers must conduct third-party testing through accredited laboratories.
• Compliance certifications must be obtained before market release.
• Packaging must have clear usage instructions to assist adults in proper opening.

---

Conclusion

Child-resistant sealing is a critical safety feature regulated by international standards such as ISO 8317, 16 CFR 1700.20, EN 14375, and ASTM D3475. Proper testing ensures that packaging is secure for children while remaining accessible to adults. Compliance with these standards helps manufacturers meet regulatory requirements and enhance consumer safety.