ISO 11070 and FDA Guidance on Guidewire Testing
ISO 11070 is a standard that ensures proper development of a safe and easy to use guidewire. Since the advent of the ISO 11070 standard, there have been various technological advancements that require additional information and clarity for new/modified guidewires, which are called out in a recent FDA Guidance document. This DDL white paper highlights and compares some of the common test requirements called out in both documents.
ISO 80369 FAQs
On October 14, 2016, ISO formally published ISO 80369 Part 7 as the replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The impact of the changes to the medical device industry have begun to sink in and momentum has been steadily building as designers are adopting the changes to meet the upcoming deadline to conform to the new standard.
As with every new standard, there are certain changes that are much more impactful than the rest and generate the bulk of the questions that come up in the course of testing. In this white paper, DDL provides responses to the most common questions customers have on ISO 80369.
ISO 80369-7: Changing the Standard for Luer Connectors
ISO formally published 80369 Part 7, the long-awaited replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The publication caps a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee’s desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes. In this white paper, DDL’s Product and Materials Engineer Levi Loesch highlights the changes that most significantly affect how one should construct their design verification plan for Luer connectors.
10 Things You Should Do Before Your Next Package Validation
Before you set out to validate a medical device package design or process, you’ve got to do your homework. You need to understand what is critical so you build the proper foundation. If your company is marketing a sterile medical device, your goal is to develop a sterile barrier system and avoid a breach of that system. Scott Levy, senior packaging engineer for DDL, offers the following 10 points to consider before beginning any validation effort.
Frequently Asked Questions about ISO 11607
ISO 11607-1 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607-1 in order to satisfy European regulations and obtain a CE Mark. ISO 11607-1 is also a FDA Recognized Consensus Standard which is used in satisfying portions of device premarket review submissions. Fulfilling the requirements within ISO 11607-1 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use.
12 Essential Steps to Deliver Your Medical Device Packaging System to the Clinical Site or Marketplace
Essential #1: Packaging Design Requirements
Defining the requirements of a packaging system as early as possible during the development process sets the stage for downstream success.
Essential #2: Hazard Analysis
Identifying possible packaging system hazards and proactively addressing them during the design phase helps to ensure patient safety.
A Dozen Words of Wisdom from a Product & Materials Test Lab
Ensuring a successful testing regimen of a medical device is a delicate matter of close communication and a common level of understanding between the OEM and the testing solution partner. To help achieve this, one lab has shared 12 tips to aid the manufacturer in understanding the best approach to take when working with a test partner.
ASTM versus ISTA for Distribution Simulation Testing
Many medical device manufactures struggle on a daily basis with what they need to do in order to comply with ISO 11607 and which procedure to utilize for performance testing, ASTM or ISTA. I am going to help you look at both from the outside in.
What is Distribution Simulation Testing?
Simply put, distribution simulation testing is a uniform and repeatable way of evaluating packaging systems by utilizing laboratory equipment to subject the packaging system to specific hazards that may occur within the anticipated distribution environment. The primarily goal is to have an effective shipping configuration that protects the product and package integrity during transit, and ultimately is in compliance with ISO 11607.