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ISO 8317:2015 – Child-Resistant Packaging

What is ISO 8317:2015?

ISO 8317:2015 specifies the requirements and testing procedures for reclosable child-resistant packaging used for potentially hazardous products. This international standard is designed to prevent children from accessing harmful contents while ensuring the package remains accessible to adults, including elderly individuals.

ISO 8317:2015

The standard applies to a wide range of consumer products such as pharmaceuticals, household chemicals, e-liquids, cleaning agents, pesticides, and cosmetic items, where ingestion or misuse could cause injury or death. ISO 8317 establishes performance-based tests that evaluate whether packaging is both resistant to child access and reclosable for multiple uses.

If your product must comply with child safety regulations in the EU, U.S., or other global markets, ISO 8317:2015 offers the most widely accepted framework for testing and compliance.

Need assistance with ISO 8317 compliance or certification? Contact support@pacificcert.com

Scope and Applicability

ISO 8317:2015 applies to:

  • Reclosable packaging that is designed to be opened and closed multiple times by consumers
  • Products that pose a risk to children under 52 months of age
  • A wide range of industries, including:
    • Pharmaceuticals (prescription and OTC drugs)
    • Pesticides and agrochemicals
    • E-liquids and vape products
    • Household cleaning agents and bleaches
    • Cosmetics with toxic or irritating ingredients

The standard ensures that packaging used for these products meets global child-safety expectations, particularly where regulations mandate child-resistant closures.

Not sure if your product falls under ISO 8317 requirements? Contact support@pacificcert.com for a free consultation!

Purpose of ISO 8317:2015

The primary objective of ISO 8317 is to:

  • Protect children from accidental poisoning or exposure to hazardous substances
  • Ensure ease of use for adults, especially the elderly or people with disabilities
  • Standardize testing methods to assess packaging safety
  • Provide a globally recognized benchmark for regulatory and industry compliance
  • Support manufacturers in product liability prevention and certification readiness

ISO 8317 is often referenced in regional safety regulations, such as:

  • The European Poison Prevention Packaging Regulations
  • The U.S. Poison Prevention Packaging Act (PPPA)

Canadian Consumer Product Safety Act (CCPSA)

Key Definitions in ISO 8317

Understanding key terms from the standard is essential:

  • Child-Resistant Packaging (CRP): Packaging that is difficult for children under a certain age to open, but easy for adults to use properly.
  • Reclosable Package: A container or system designed to be opened and closed multiple times, retaining its child-resistant characteristics after repeated use.
  • Test Panel: Groups of children (ages 42–51 months) and adults (typically 50–70 years) used for performance testing.
  • Failure Rate: The percentage of test subjects who are able to open the package when they shouldn’t be able to (for children), or unable to open it when they should be able to (for adults).

We help you interpret and apply these terms to your specific product category, email support@pacificcert.com

Testing Procedures for ISO 8317 Compliance

  1. Child-Panel Test
    Performed with children aged 42 to 51 months. Packaging must withstand attempts to open it by at least 85% of children within 5 minutes. If shown how to open it and given another 5 minutes, 80% must still be unable to open it.
  2. Adult-Panel Test
    Conducted with adults aged 50–70 years to ensure usability. 90% of adults must be able to open and properly reclose the packaging within a specified time.
  3. Re-closure Integrity Test
    After multiple openings and reclosures, the packaging is re-tested to ensure it maintains its child-resistant properties over time.
  4. Mechanical and Environmental Conditioning
    Packaging may undergo additional mechanical stress or environmental exposure (e.g., humidity, heat) to simulate real-world conditions before testing.

These rigorous tests are conducted in accordance with ISO-defined procedures to ensure standardization and reliability.

Need testing support through accredited labs? Contact support@pacificcert.com.

How to Implement ISO 8317:2015

Implementation involves a mix of design, documentation, testing, and compliance tracking:

  1. Design & Development
    Start by designing packaging with built-in safety features (e.g., push-and-turn, squeeze-and-turn closures).
  2. Prototype Testing
    Submit packaging samples to ISO 8317-compliant laboratories for pre-certification testing with child and adult panels.
  3. Documentation
    Prepare technical documentation that includes:
    • Design drawings
    • Material specifications
    • Test protocols and results
    • Instructions for use and labeling
  4. Third-Party Certification (optional but recommended)
    Some markets require or prefer packaging to be certified by an accredited body based on ISO 8317 test results.
  5. Ongoing Compliance Monitoring
    Periodically retest packaging after material changes, or based on shelf-life considerations.

Need help with end-to-end ISO 8317 implementation? Email us at support@pacificcert.com.

Documentation Required

To demonstrate compliance with ISO 8317, manufacturers should maintain:

ISO 8317:2015

  • Child and adult panel test reports
  • Drawings and specifications of closure systems
  • Instructions for proper use by adults
  • Re-closure functionality validation
  • Declaration of conformity (if required by local laws)
  • Certificates of testing or third-party verification (if applicable)

We provide support for ISO 8317 contact us at support@pacificcert.com!

Benefits of ISO 8317:2015 Compliance

  • Protects children from accidental poisoning or injury due to unsafe packaging.
  • Supports fulfillment of legal obligations in Europe, North America, and other regulated markets.
  • Demonstrates social responsibility and prioritization of consumer safety.
  • Documented compliance with ISO 8317 provides a strong defense in product liability cases.
  • Required or expected by many retailers, importers, and regulators for product approval.
  • Balancing child resistance with adult accessibility prevents frustration and misuse.
  • Compatible with sustainable packaging trends, when designed responsibly.

Benefits of ISO 8317:2015

Lately, child-resistant packaging is more than a regulatory requirement, it’s a market differentiator. With increasing incidents of child poisoning due to household products and cannabis edibles, regulators across the globe are tightening packaging mandates.

Key market trends include:

  • Expansion of CRP to e-cigarettes, cannabis products, and cosmetics
  • Integration of smart closures for tamper evidence and tracking
  • Growing demand for sustainable child-resistant materials
  • EU and U.S. aligning ISO 8317 with digital labeling and e-commerce packaging guidelines
  • The global CRP market is projected to grow at 7.2% CAGR, reaching over $35 billion by 2030 (source: MarketsandMarkets, 2024)

ISO 8317 compliance ensures manufacturers stay ahead of regulatory changes, consumer expectations, and market access barriers.

Want to future-proof your packaging systems? Contact support@pacificcert.com.

How Pacific Certifications Can Help

We provide full support for ISO 8317 compliance and certification:

  • CRP design review and testing preparation
  • Guidance on child and adult panel testing protocols
  • Documentation development (technical file, use instructions, declarations)
  • Coordination with accredited test labs
  • Certification support for EU, U.S., and Canadian regulatory markets
  • Integration with ISO 9001, ISO 15378, or GMP frameworks

Whether you’re launching a new product or updating existing packaging, we help ensure it meets global safety standards.

Start your ISO 8317 compliance project today, contact support@pacificcert.com

FAQ on ISO 8317:2015

Not by itself, but it is referenced in legislation in many countries, making it the de facto requirement for regulated products.

Children aged 42 to 51 months are used in standardized panel tests.

Yes, it applies to any product requiring child-resistant, reclosable packaging—regardless of industry.

No. For single-use child-resistant packaging, refer to ISO 14375.

You can self-assess, but third-party certification or lab testing is often required by regulators and clients.

Ready to get ISO 8317 certified?

Contact Pacific Certifications to begin your certification journey today!

Suggested Certifications –

  1. ISO 9001:2015
  2. ISO 14001:2015
  3. ISO 45001:2018
  4. ISO 22000:2018
  5. ISO 27001:2022
  6. ISO 13485:2016
  7. ISO 50001:2018

 

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ISO 8317

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