What is ISO 11607 ?
The process of developing and constructing a packaging system for terminally sterilized medical devices is a convoluted and pressing endeavor. The definitive nature of the medical device, the intended sterilization methods, the intended use, expiration date, transport, and storage all influence the packaging system design and choice of materials. The combination of the medical device and the packaging system should perform efficiently, safely, and adequately in the end-user’s hands. ISO 11607-1 details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods. ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users of sterile medical devices.
Benefits of ISO 11607 Certification
Leading to Better
Actionable Data
Product Quality
Improves customer confidence
Insight into your Supply Chain
Safety Assurance
Check out the Who can be certified ISO 11607 Certification Video
Who can be certified ISO 11607 Certification?
Injection
Testing Kits
Medical Furniture
Medical Equipment
IVD Instruments
Surgical Instruments
Dental Implants
Ortho Implants
Disposable Syringes Needles
Document required for ISO 11607 Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of ISO 11607 Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Day 1
GAP Analysis, Certification Body, Selection, Cost Estimates
• Finding the GAP between existing system related to ISO 11607 requirements
• Selecting the appropriate certification Body
• Based on the scope of your business & certification Body you choose
Week 1
Developing Documents
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
• ISO 11607 Awareness training for the top management and staff
• Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
• Internal audits identifying nonconformities related to ISO 11607 requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the certification body
Week 12
Certification Body
• ISO 11607 certificates issued for 1 years
Year on Year
Yearly Compliance
• Support of Yearly documentation for audit
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
What is BS EN ISO 11607-1:2020 about? This is the first of two international standards written to ensure that terminally sterilized medical device packaging allows sterilization, provides physical protection and maintains sterility to the point of use.