ISO 11607
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
Overview for 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
Rationale For the Use of ISO 11607
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:
- ISO 11607 is an international standard that specifies requirements and test methods for packaging of sterile medical devices.
- ISO 11607 outlines the requirements for materials selection, package design and construction, sealing processes, and packaging validation.
- The standard also emphasizes the importance of design validation and process validation to ensure the effectiveness of the packaging system.
- Compliance with ISO 11607 is essential for medical device manufacturers to meet regulatory requirements and ensure the safety and effectiveness of their products.
- ISO 11607 is recognized globally and serves as a benchmark for best practices in medical device packaging.
Related Standards:
- ASTM F1886 - Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
- ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F2096 - Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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Related Testing Standards
- ASTM D642
- ASTM D685
- ASTM D880
- ASTM D951
- ASTM D999
- ASTM D3078
- ASTM D3103
- ASTM D3285
- ASTM D4169
- ASTM D4332
- ASTM D4728
- ASTM D5265
- ASTM D5276
- ASTM D5277
- ASTM D5487
- ASTM D6055
- ASTM D6179
- ASTM D6344
- ASTM D6653
- ASTM D7386
- ASTM F88
- ASTM F1140
- ASTM F1886
- ASTM F1929
- ASTM F1980
- ASTM F2096
- ASTM F2250
- ASTM F3039
- ASTM D1596
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Affiliations
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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