AAMI-logo-RGB-no-tagline
  • AAMI Foundation
  • About AAMI
    • Leadership
    • AAMI Center for Excellence
    • Strategic Plan
    • Directions to AAMI
    • Press Room
    • AAMI Foundation
  • Join/Renew
  • News/Resources
    • Press Room
    • News
    • Publications
    • AAMI Podcast
    • COVID-19 Updates
  • Engage
    • AAMI Connect
  • Store
    • Store
    • AAMI eSubscription
  • My Account
    • Renew
    • My Account
    • Logout
  • Standards
    • What are Standards?
    • How are Standards Developed
    • Search For a Committee
    • View Full Committee List
    • Standards Monitor Online
    • Participate in Standards Development
  • Training & Certification
    • About ACI
      • Maintain Your Certification
      • Certification Directory
      • ACI FAQs and Resources
    • Training Suites
      • Quality Systems
      • Human Factors
      • Sterilization
      • Software/Cybersecurity
      • Healthcare Technology Management (HTM)
      • Regulatory
    • Private Training
    • Access My Learning
  • Events
    • View All Events
    • Hotels Near AAMI
    • AAMI Center for Excellence
    • ICEHTMC 2021
    • AAMI Exchange 2021
  • Membership
    • Individual Membership
    • Institutional Membership
    • Corporate Membership
    • Awards
      • Bright Ideas
      • Michael J Miller Scholarship Program
    • Mentorship Program
    • AAMI Fellow Program
    • Career Center
  • Who We Serve
    • Healthcare Technology Management
      • Get Certified!
      • HTM Resources
      • Health Technology Alliance (HTA)
      • #IamHTM Campaign
      • HTM in a Box
    • Sterilization Professionals
    • Medical Device Manufacturers

AAMI Standards Monitor Online 10 July 2020

Standards Monitor Online

  • Recently Published
  • Call for Comments
  • New Work
  • Consensus
  • Upcoming Meetings
  • Issues
 

About Standards Monitor Online

 

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:

 

 

From July 23 – August 1, our database will be offline for planned upgrades. During this time, AAMI will not be able to process any changes to Standards group rosters, update your account information, or reset your password. In addition, your interactions with AAMI Committee Central may also be affected. In the interim, for requests to be added to additional standards groups, you may email standards@aami.org with your completed committee application, which can be downloaded here, and we will process your request as soon as our systems are operational. You will receive confirmation of your transaction at that time.

Download PDF

 

Recently Published

 
  •  AAMI/ISO TIR24971:2020 NEW! AAMI/ISO TIR24971:2020

    Medical devices—Guidance on the application of ISO 14971. Purchase here.

  • ANSI/AAMI/ISO 10993-11:2017 ANSI/AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood. Purchase here.

  • ANSI/AAMI/ISO 10993-1:2018 ANSI/AAMI/ISO 10993-1:2018

    Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process. Purchase here.

  • ANSI/AAMI/ISO 10993-11:2017 ANSI/AAMI/ISO 10993-11:2017

    Biological evaluation of medical devices—Part 11: Tests for systemic toxicity.Purchase here.

 

AAMI Call for Comments

 

If you would like to comment on one of the draft documents listed below, contact the individual indicated by e-mail to receive a PDF copy of the draft. These copies are free.

 

Published documents proposed for reaffirmation can be purchased from the AAMI Store.

Comments due July 27, 2020

AAMI/ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (reaffirmation of an American National Standard). Specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. Applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. Intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of products to be sterilized and organizations responsible for sterilizing medical devices.

Purchase

 

Comments due August 10, 2020

AAMI 2700-2-1, Medical Devices and Medical Systems — Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements or forensic Data logging (new American National Standard). This document provides general functional, performance, and interoperability requirements of ICE data logging systems including the recording and storage of data in support of forensic analysis of ICE systems. Data logs, data logging, and data loggers can play an important role in maintaining and improving the basic safety and essential performance of integrated clinical environments by enabling the forensic assessment of the ICE system and its components.

Contact:wvargas@aami.org

 

 

New Work

 

AAMI/CN, Small Bore Connectors Committee is working on the revision of AAMI/ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications. Contact: Colleen Elliott

AAMI EQ, Medical Equipment Management Committee. The committee is working on the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. This standard seeks to provide a recommended framework for new or established education programs in health care technology management (HTM). Contact: Patrick Bernat.

Consensus Body Members Needed

 

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:

User

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

Industry

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.

Regulatory

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

General interest

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.

GettyImages-1148381484
 

Please contact the staff person indicated for more information on how to join.

  • AAMI/CN, Small Bore Connectors Committee. The committee is seeking user, regulatory and general interest members to participate in the development of AAMI/ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications. Contact: Colleen Elliott/li>
  • AAMI EQ, Medical Equipment Management Committee. The committee is seeking industry, regulatory and general interest members to participate in the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. Contact: Patrick Bernat
  • AAMI ST/WG 95, Water Quality for Reprocessing Medical Devices. The working group is general interest, user, and regulatory stakeholders to participate in the development of AAMI ST108/Ed.1, Water for the processing of medical devices. Contact: Amanda Benedict.
  • AAMI ST/WG 40, Hospital Practices Steam Sterilization. The working group is seeking regulatory and general interest stakeholders to participate in the developments of AAMI TIR109/Ed.1, External transport of medical devices processed by health care facilities. Contact: Amanda Benedict
  • AAMI/CV, Cardiac valves. The committee is seeking general interest/regulator members to participate in the revision of ISO 5910, Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices. Contact: Cliff Bernier
  • AAMI/VP, Vascular Prostheses. The committee is seeking user and general interest/regulator members to participate in the revision of ISO 25539-3, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters and the development of ISO 25539-4, Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices. Contact: Cliff Bernier
  • AAMI/BG, Blood/Gas Exchange Device Committee. The committee is seeking industry, user, and general interest/regulator members to participate in the development of the following Cardiovascular implants and artificial organs documents: ISO 18193, Cannulae for extracorporeal circulation; Amendment 1 to ISO 18242:2016 Centrifugal blood pumps for pulsatile pumps; and revision of ISO 7199, Blood-gas exchangers. Contact: Cliff Bernier
  • AAMI/VP-WG 01, Vascular Device-Drug Combination Products. The committee is seeking industry, user and general interest/regulator members to participate in the revision of ISO 12417-1:2015, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements and the revision of ISO/TR 12417-2:2017, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information. Cliff Bernier
  • AAMI/VI, Cardiovascular absorbable implants. The committee is seeking industry, user, and general interest/regulator members to participate in the revision of ISO/TS 17137:2019, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants. Contact: Cliff Bernier
  • AAMI/CO, Cardiac Occluders. The committee is seeking industry, user, and general interest/regulator members to participate in the development of ISO 22679, Cardiovascular implants — Transcatheter cardiac occluders. Contact: Cliff Bernier
  • AAMI/SM-WG03, Interoperability Working Group. The committee is seeking user, general interest, and regulator members to participate in the development of AAMI 2700-2-1, Medical Devices and Medical Systems — Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements or forensic Data logging. Contact: Wil Vargas
 

Upcoming Meetings

 

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 (standards@aami.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.

July 2020
  • Infusion Device Committee (remote open meeting). 28 July 2020. 13:30 h to 15:30 h ET. Contact: Jennifer Moyer.
August 2020
  • ST-WG 8, Microbiological Methods Working Group (remote open meeting). 7 August 2020, 11:00 h to 14:00 h ET, and 10 August 2020, 13:00 h to 15:00 h ET. Contact: Amanda Benedict.
September 2020
  • Infusion Device Committee (remote open meeting). 1 September 2020. 13:30 h to 15:30 h ET. Contact: Jennifer Moyer.
October 2020
  • AAMI Sterilization Standards Week - details to come! (open meetings – advance registration will be required) 12-16 October 2020, AAMI, Arlington, VA, USA. Please note that these meetings are currently planned as being held in-person with a remote participation option; it might be necessary to change to fully remote meetings, depending on circumstances closer to the date of the meetings. Contact: Amanda Benedict
 

International 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.

July 2020
  • ISO/TC 198/WG 6, Chemical indicators (closed meeting), 8 July 2020, 8:00 h to 12:00 h ET, Zoom meeting. Contact: Amanda Benedict
August 2020
  • ISO/TC 150/SC 6/WG 4, Implantable infusion pumps (remote closed meeting), 5 August 2020 and 12 August 2020, 11:00 h to 13:00 h ET, Zoom meeting. Contact: Jennifer Moyer
  • ISO/TC 198/WG 8, Microbiological methods (closed meeting), 24/25 August 2020, 09:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
September 2020
  • ISO/TC 198/WG 8, Microbiological methods (closed meeting), 1/2 September 2020, 09:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict

 

Issues

May 22, 2020

May 1, 2020

April 10, 2020

March 20, 2020

February 28, 2020

 

AAMI | Advancing Safety in Health Technology
901 N. Glebe Road, Suite 300
Arlington, VA 22203

T +1 703-525-4890
F +1 703-525-1424
Facebook Twitter Instagram LinkedIn YouTube
  • Site Map
  • Contact Us
  • AAMI Foundation
  • Advertise
  • AAMI Policies
  • Intellectual Property
  • Careers at AAMI
© 2020 Association for the Advancement of Medical Instrumentation. All Rights Reserved.