AAMI Standards Monitor Online 13 January 2023
Standards Monitor Online (SMO) is a free subscription service that is delivered to your email every three weeks. This AAMI resource keeps you up to date with standards-related activities:
NEWSWORTHY!AAMI hosted the meetings of ISO/TC 198 and affiliated working groups in Arlington, Virginia, USA in early December 2022. Click here for a video interview with Emily Craven, director of sterility assurance at Boston Scientific, regarding the radiation sterilization standards ecosystem.
PUBLISHED! Be sure to check back in the coming weeks on publication of ANSI/AAMI/ISO 18472:2022, Sterilization of health care products—Biological and chemical indicators—Test equipment.
PUBLISHED! Be sure to check here soon on the publication of the national adoption of ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The next AAMI Standards Insider webinar will be held on Thursday, February 16th from 1:00-2:00 PM ET. The one-hour FREE webinar provides news and updates about AAMI’s standards program and portfolio. Registration for the upcoming webinars and recordings of past webinars in the series – including the November 17th session - will be available on the webpage. Check back soon!
AAMI/CDV-1 HIT1000-2, Health IT software and systems—Part 2: Application of quality systems principles and practices (proposed new American National Standard) Specifies a process to build on the principles in existing quality systems principles and practices, as well as identify the specific roles and responsibilities needed to ensure health IT safety and quality as well as patient safety hazards associated with health IT software and systems, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Contact: Chenai Maguwah
AAMI/CDV-1 HIT1000-3, Safety and effectiveness of health IT software and systems—Part 3: Application of risk management (proposed new American National Standard) Identifies the core concepts and principles needed to maintain safe and effective health IT software and systems to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Contact: Chenai Maguwah
AAMI /CDV-1 HIT1000-4, Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering (proposed new American National Standard) Describes an approach to developing and validating a health IT system’s user interface so that such systems are safe and effective. The intent is to promote good development practices without being overly prescriptive. As such, this standard covers the development, acquisition, integration, implementation, and operational use lifecycle stages. Additionally, this standard includes a section describing usability considerations for health IT system replacement and decommissioning. Contact: Chenai Maguwah
AAMI/ISO 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic toxicity (reaffirmation of an American National Standard) Specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. Contact: Chenai Maguwah
AAMI/ISO CDV-1 13004, Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD (proposed new American National Standard) Specifies a method or substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less or radiation sterilization o health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. Contact: Tommy Kim
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use Committee. The committee has recently approved development of a new AAMI Technical Information Report (TIR) on Guidance for Closed System Transfer Device Testing with Hazardous Drugs. This TIR seeks to provide guidelines for physical and chemical compatibility of the drug with the Closed System Transfer Device (CSTD), which may include but not limited to holdup volume, coring/fragmentation of the vial rubber stopper, microbial ingress, stability/shelf-life, and usability. TIB-WG04 is seeking cochairs, user, regulatory and general interest members to participate in the development of AAMI TIR112. The group will begin having monthly meetings (1st Wednesday of every month, 9am CST) beginning in 2023. Contact: Sam Alameda
The committees listed below are seeking new members in the indicated stakeholder interest category to participate in the development of their documents. Definitions of the various stakeholder groups are:
An individual or organizational representative, who purchases, utilizes or receives the materials, products, systems, or services covered in the scope of technical documents developed by AAMI in the delivery of healthcare; individuals in this interest category include clinicians, employees or representatives of Healthcare Delivery Organizations, clinical consultants, patients, etc
An individual or organizational representative involved in the commercial production, promotion, sale, use or distribution of materials, products, systems, or services covered in the scope of technical documents developed by AAMI; this interest category includes manufacturers, those involved in supply chains, employees of test labs or commercial labs, industry consultants, etc.
An individual or organizational representative involved in the regulation of the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI; this interest category includes those representing federal, state, local, foreign, or other government entities
An individual or organizational representative with a general material interest in the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI and who does not fit into any of the preceding categories; this interest category can include noncommercial academicians, noncommercial researchers, patient or consumer advocates, representatives of accrediting organizations, representatives of other organizations, etc.
Please contact the staff person indicated for more information on how to join.
AAMI Committees and U.S. TAGs
Open meetings of AAMI committees and U.S. Technical Advisory Groups (TAGs) are listed here and at the AAMI website (www.aami.org). Note: If you plan to attend a meeting, please send a brief note to the AAMI Standards Department (firstname.lastname@example.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
AAMI/ID Committee, Infusion Device (open meeting) 13 January 2023, 13:00h to 15:00h EST, web meeting. Contact: Ladan Bulookbashi
AAMI/SM-WG01, Software Working Group (open meeting) 18 January 2023, 12:00h to 13:00h EST, web meeting. Contact: Chenai Maguwah
AAMI/PC-WG03, Pacemaker & ICD MRI Compatibility (open meeting) 19 January 2023, 10:00h to 11:30h EST, web meeting. Contact: Ladan Bulookbashi
AAMI/SM-WG10, Cloud Computing Working Group (open, in person meeting) 24-25 January 2023, 08:00h to 16:00h EST, Delray Beach FL. Contact: Chenai Maguwah
AAMI/TIB-WG04, Elastomeric parts, components and packaging (open meeting) 1 February 2023, 10:00h – 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month, from 10:00h – 11:00h EST. Contact: Sam Alameda
AAMI Spring 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in January 2023). 20-24 March 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
AAMI Fall 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in July 2023). 11-14 September 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
Information on draft international standards under ballot can be found in ANSI Standards Action.International Committee and Working Group Meetings
Call or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
ISO/TC 215 – IEC/SC 62A/JWG 7 in conjunction with ISO/TC 215, Health Informatics (closed meetings). 9-13 January 2023, 8:30h to 17:00h, Sapporo, Japan. Contact: Hae Choe
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care (closed meeting). 29 January 2023, 17:00h to 20:00h EDT, Plenary meeting. Contact: Colleen Elliott
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care (closed meeting).
2 February 2023, 17:00h to 20:00h EDT, Plenary meeting. Contact: Colleen Elliott