ISO 11607 is a set of international standards for packaging of medical devices. It specifies requirements and test methods for the design and validation of packaging systems to ensure the safety and effectiveness of medical devices throughout their lifecycle. The standards cover aspects such as materials, sterile barrier systems, sealing processes, and labeling. Compliance with ISO 11607 is important for medical device manufacturers to meet regulatory requirements and ensure the integrity of their products during storage, transportation, and use.

ISO 11607

ISO 11607 covers aspects such as selection of materials, packaging design, seal strength testing, microbiological methods, and transportation testing. The standard also addresses labeling requirements to communicate critical information about the device and its packaging to end-users.
Compliance with ISO 11607 is essential for ensuring the safety and efficacy of medical devices and helps manufacturers meet regulatory requirements in various countries. The standard is regularly updated to incorporate new technologies and best practices in packaging design and testing.
Components

Single or double packaging can be used, depending on the type and shape of the products and the geometry of the packaging. Some examples are:

  • The packaging are pouches or blister packs.
  • All the packaging components for the device must be non reusable.
  • The device’s packaging guarantees sterility throughout the storage-life specific on the labelling under normal conditions of storage and transport.
  • Validation for the devices should be performed.
Materials
  • Gas-porous materials. For these materials, the micro-organism barrier properties shall be validated.
  • Waterproof materials that are plastic
Sealing
  • Sealing temperature 
  • Sealing time sealing pressure
ISO 11607 is a set of standards that outline requirements for packaging materials and systems used for medical devices. The rationale for its use includes:
1. Ensuring the safety of medical devices during storage, transportation, and use: Proper packaging is essential to protect medical devices from contamination, damage, and degradation, which can impact their safety and effectiveness.
2. Regulatory compliance: ISO 11607 provides a framework for meeting regulatory requirements related to the packaging of medical devices, helping manufacturers demonstrate compliance with quality standards and regulations.
3. Consistency and standardization: By following the guidelines outlined in ISO 11607, manufacturers can ensure consistency in packaging design and testing processes, leading to more reliable and predictable outcomes.
4. Cost-effectiveness: Properly designed and tested packaging can help reduce the risk of product recalls, returns, and complaints, ultimately saving manufacturers time and money.
Overall, the rationale for using ISO 11607 is to ensure that medical devices are safely and effectively packaged, meeting regulatory requirements, maintaining product integrity, and minimizing risks to patients and users.

Standards and Regulations

  • ISO 11607-2 (2006) – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, an packaging systems
  • ISO 11607-2 (2006) – Packaging for terminally sterilized medical devices – Part 2: Validation requirement for forming, sealing, and assembly processes
  • Test methods standards listed in ISO 11607-1 2006 — Annex B

Key Points:

Related Standards:

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Accreditations

Achieving ISO 17025 Accreditation is the pinnacle in third-party laboratory testing accreditation. It confirms that the facility has management, quality, and technical systems in place to ensure accurate and reliable analyses.
ISTA is revered as the certification standard for package testing for distribution. ISTA’s Testing Protocol remains a series of testing methodologies and standards well recognized within the packaging community.
A select few companies are authorized by PHMSA as an approved third-party packaging testing laboratory in accordance with Hazardous Materials Regulations, critical to ensuring safe transport of dangerous goods.

Affiliations

With over 12,000 standards globally, ASTM International’s fully transparent standards development enhances performance and confidence in consumer choices.
The Technical Association of Pulp and Paper Industry’s peer-reviewed standards improve production through operational methods and industry recognized best practices.

 

 The APASS program was designed by Amazon to help support vendors, sellers, and manufacturers in obtaining certification of their products as Frustration Free Packaging (FFP), Ships in Own Container (SIOC), or Prep-Free Packaging (PFP).

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