Martell Winters is Convener for ISO WG16

martell_winters_3It was recently announced that Martell Winters, B.S., RM/SM(NRCM) was appointed and approved as convenor for a three-year term of a new ISO working group, WG16, on vaporized hydrogen peroxide sterilization. The new working group is tasked with developing a new standard to provide requirements and guidance for developing sterilization processes for vaporized hydrogen peroxide. The ISO document has been named ISO 22441, Sterilization of healthcare products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

“I’m honored to be considered and appointed as convenor of WG16,” Martell said about the appointment. “I look forward to working with the members of the group as we develop this new standard. There are a good number of experts in vaporized hydrogen peroxide involved, so I am confident that our efforts will result in a technically correct and useful standard.”

Previously, vaporized hydrogen peroxide sterilization was addressed under the general sterilization criterial standard, ISO 14937, which provides general requirements for any sterilizing agent which does not already have a specific standard. It was felt by the international community that vaporized hydrogen peroxide had gained enough acceptance and use in the industry that it merited having its own standard.

The US body which will be participating in this ISO working group will be AAMI WG16, which is also a new working group and is currently being established. Anyone who has interest in being involved with this new AAMI working group should contact AAMI.

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs.

The experts at Nelson Labs are teaming with MD+DI to bring a live three-day webinar event that provides manufacturers of medical devices and pharmaceutical products with the most up-to-date regulatory updates, trends, and anticipated changes (including FDA, ISO, USP, and MDRs). Online registration is currently available on the MD+DI website. Many of those speaking contribute to committees that provide global guidance to safeguard patient health; each webinar will offer 15 minutes for audience questions with these experts. Details for each webinar are as follows:


Title: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes

Date: Tuesday, 26 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour


This presentation will discuss the recent and upcoming changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices. The presentation will include:

  • Discussion about how biocompatibility assessments are affected by the recent updates to the ISO 10993-1 document and the new European MDRs.
  • Anticipated changes to ISO 10993-18. Since the use of chemistry in the biocompatibility assessment of medical devices is gaining traction, the document that outlines how to use chemical characterization for these assessments is undergoing major revisions.
  • An overview of changes that are expected with the acceptance of in-vitro irritation testing.
  • A thorough review of the impact of the recently finalized ISO 18562 standard which specifically targets respiratory contact devices.


Thor Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting

Matthew R. Jorgensen, PhD
Chemical and Materials Scientist


Title: Sterilization Methodologies and Packaging Integrity Testing: Updates, Trends, and Anticipated Changes

Date: Wednesday, 27 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Sterilization methodologies and packaging integrity testing are necessary to ensure patient safety. The sterilization portion of the webinar series discusses recent and upcoming changes to regulatory documents and standards such as:

  • Changes that impact steam, radiation, hydrogen peroxide, and ethylene oxide sterilization modalities.
  • What to expect in the new ISO document for hydrogen peroxide sterilization.

As part of the packaging presentation key points regarding the new European MDRs will be reviewed, including:

  • How medical device manufacturers can collect and document objective evidence of compliance for their packaging, look at designs that prevent microbial contamination at the point of use, and justify that the package is suitable for current use.
  • An introduction to a new leak-testing technology, Mass Extraction, that demonstrates container closure integrity in a non-destructive and rapid manner, will be presented. This new test meets the deterministic requirements as outlined in the newly published USP chapter 1207.


Martell K. Winters, B.S., SM (NRCM)
Director, Scientific Competency

Jason Pope, B.S., ASQ CQA
Senior Scientist

Wendy Mach, RM (NRCM), CQA (ASQ)
Packaging Section Leader


Title: Cleanliness Testing for Medical Devices: Updates and Trends

Date: Thursday, 28 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour


This presentation will cover the latest updates and current trends for medical device cleanliness testing. This webinar will include:

  • A review of the upcoming and highly anticipated orthopedic implant cleanliness ISO document.
  • A discussion about the testing considerations for certain additive manufacturing processes.
  • Guidance updates for reusable device validations.
  • An update regarding the reprocessing of single-use devices.


Alpa Patel, B.S., RM (NRCM)
Senior Scientist

Alexa Tatarian
Study Director III

Paul L. Littley, B.S.E
Consulting Manager

ISO 16775: The Medical Device Packaging Professional’s Latest “Must Have”

Medical Device Package Testing. Learn more at

Medical Device Package Testing. Learn more at

By: Jennifer Gygi, Nelson Laboratories, Inc. Packaging Department Scientist, SM (NRCM)

If you are involved in the packaging of medical devices, your primary standards reference has probably been the International Organization for Standardization (ISO) 11607 publication for packaging design and validation. However, this standard was lacking much of the detail and guidance many packaging engineers were seeking; therefore ISO recently published a new standard, ISO 16775 – Packaging For Terminally Sterilized Medical Devices – Guidance On The Application Of ISO 11607-1 And ISO 11607-2, a comprehensive guide to all things packaging.

The new standard references the fundamental concepts outlined in ISO 11607 but takes it to the next level, providing practitioners additional detail.  More specifically, ISO 16775 highlights what makes a sterile barrier system (SBS), what the SBS requirements are, design considerations, materials selection, labeling issues, and package assembly to name a few.

ISO 16775 also details common packaging configurations and applications, and walks users through the entire package testing process step by step. From creating the validation plan to installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) on the sealing equipment, to testing final product/packaging for strength, integrity, and microbial barrier properties over time, ISO 16775 has you covered.

Where ISO 11607 speaks in generalities, ISO 16775 gives specifics. The meat of the document is found in the 19 appendices covering topics including but not limited to:

  • Guidance for health care facilities for creating SBS and performing validations
  • Selection of materials, design input, risk analysis tools, and sampling plans
  • Using contract packagers
  • Establishing processing parameters
  • Failure investigations, and design feasibility

ISO 16775’s appendix even includes example forms / checklists that can be used for IQ, OQ, and PQ  validations.

How ISO 16775 May Affect You

ISO 16775 is a “must have” for medical device packaging professionals.  It covers not only pre-formed SBS systems, but addresses many of the challenges unique to health care facilities, with extensive information on wraps and containers.

If you are experienced in medical device packaging, ISO 16775 will be a review of topics you are already familiar with, supplemented by new and valuable insights.  If you are a newcomer to packaging, this document is your new best friend.  ISO 16775 is a great reference to add to any library.