CERTIFICATION IN INDIA

ISO 11607 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

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

Who can be certified ISO 11607 Certification?

Shamkris Group

Injection

Shamkris Group

Testing Kits

Shamkris Group

Medical Furniture

Shamkris Group

Medical Equipment

Shamkris Group

IVD Instruments

Shamkris Group

Surgical Instruments

Shamkris Group

Dental Implants

Shamkris Group

Ortho Implants

Shamkris Group

Disposable Syringes Needles

Document required for ISO 11607 Certification

The extent of Documented Information differs as per:

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:

Time Frame

Task

Process

Day 1

GAP Analysis
Certification Body
Selection
Cost Estimates

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Certification Body
Audit
N-C Closing

Week 12

Certification Body

Year on Year

Yearly Compliance

FAQ

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.