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AAMI Standards Monitor Online 20 February 2021

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:

 

Download PDF

 

 

 

Recently Published

 
  • NEW! ANSI/AAMI/ISO 10993-16:2017,

    Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. Purchase here.

  • REAFFIRMED! AAMI TIR74, Change Summary For ISO 11135:2014,

    Sterilization Of Health Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices was reaffirmed February 11, 2021.

 

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 March 15, 2021

AAMI/ISO 13408-5, Aseptic processing of health care products - Part 5: Sterilization in place (reaffirmation of an American National Standard). This standard specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This document applies to processes where sterilizing agents are delivered to the internal surfaces of the equipment that can come in contact with the product. Contact: Amanda Benedict

 

New Work

 

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: Amanda Benedict.

AAMI QM-WG01, Application of Quality Systems to Medical Devices Working Group. The working group is working on the development of AAMI CR510, Consensus Report on Compliant Use of Cloud Computing for Quality Systems and Medical Devices. This Consensus Report will provide guidance to multiple stakeholders regarding the appropriate and compliant use of cloud computing both as a component of medical devices and in support of quality systems. Contact: Joe Lewelling.

AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. The committee has recently approved development of an AAMI Technical Information Report (TIR), 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 Close 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. Contact: Jeff Linder.

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.

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

  • 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: Amanda Benedict.
  • 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: Amanda Benedict.
  • AAMI ST-WG 91, Resistometers. The working group is seeking user, industry, and regulatory/general interest stakeholders to participate in the US adoption of ISO 18472:2018, Sterilization of health care equipment – Biological and chemical indicators – Test equipment. Contact: Cliff Bernier.
  • AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. The committee and its affiliated working groups are seeking user, industry, and general interest/regulator members to participate in developing the US position towards documents under development in ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use, and other projects. Contact: Jeff Linder.
  • AAMI/CV, Cardiac valves. The committee is seeking user, industry, and general interest/regulator members to participate in the US adoption of ISO 5840-1:202x, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements; ISO 5840-2:202x, Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes; ISO 5840-3:202x, Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques; and the revision of ISO 5910:2018, Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices. Contact: Cliff Bernier.
  • AAMI/VP, Vascular Prostheses. The committee is seeking user, industry, and general interest/regulator members to participate in the US adoption of ISO 25539-2:2020, Cardiovascular implants — Endovascular devices — Part 2: Vascular stetnts; 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 user, industry, 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 user, industry, 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. Contact: Cliff Bernier
  • AAMI/VI, Cardiovascular absorbable implants. The committee is seeking user, industry, 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 user, industry, and general interest/regulator members to participate in the development of ISO 22679, Cardiovascular implants — Transcatheter cardiac occluders. Contact: Cliff Bernier
  • AAMI/RD, Renal Disease and Detoxification Committee. The committee is seeking industry, user, and general interest/regulator members to participate in the revision of the ISO 23500:2019 , Preparation and quality management of fluids for haemodialysis and related therapies series standards: Part 1: General requirements; Part 2: Water treatment equipment for haemodialysis applications and related therapies; Part 3, Water for haemodialysis and related therapies; Part 4: Concentrates for haemodialysis and related therapies; Part 5, Quality of dialysis fluids for haemodialysis and related therapies; and the revision of the ISO 8637, Extracorporeal systems for blood purification series standards: Part 1, Haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators,;Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters; and Part 3, Plasmafilters. Contact: Cliff Bernier
  • AAMI/HIT-WG02, Health IT Quality Systems Working Group. The working group is seeking industry, general interest, and regulator members to participate in the development of AAMI HIT1000-2/Ed., Health IT software and systems — Part 2: Application of quality systems principles and practices. Contact: Emily Hoefer
 

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.

February 2021

Industrial Moist Heat Sterilization Working Group (open web meeting). 22 and 23 February 2021, 12:00h to 15:00h ET. Virtual meetings.  Contact: Amanda Benedict.

HIT Risk Management Working Group (open web meeting). 24 February 2021, 13:30h to 15:00h ET. Virtual meeting. Contact: Emily Hoefer

Small-bore Connectors Committee (open web meeting). 25 February 2021, 10:00h to 11:00h ET. Contact: Colleen Elliott.

March 2021

AAMI COVID-19 Response Team (open web meeting). 17 March 2021, 15:00h to 16:00h ET. Contact: Colleen Elliott.

AAMI Sterilization Standards meetings (open web meetings). 22 March through 1 April 2021, 08:00h to 17:00h ET. Schedule of meetings in development. Virtual meetings.  Contact: Amanda Benedict.

Radiation Sterilization Working Group (open web meeting). 22 March 2021, 13:00h to 17:00h ET. Virtual meeting.  Contact: Amanda Benedict.

Industrial EO Sterilization Working Group (open web meeting). 23 March 2021, 13:00h to 17:00h ET. Virtual meeting.  Contact: Amanda Benedict.

Compatibility of Material Subject to Sterilization Working Group (open web meeting). 26 March 2021, 10:00h to 12:00h ET. Virtual meeting.  Contact: Cliff Bernier.

Assurance of Sterility Working Group (open web meeting). 26 March 2021, 13:00h to 17:00h ET. Virtual meeting.  Contact: Amanda Benedict.

Water Quality fo Reprocessing Medical Devices Working Group (open web meeting). 29 March 2021, 11:30h to 17:00h ET. Virtual meeting.  Contact: Amanda Benedict.

Microbiological Methods Working Group (open web meeting). 30 March 2021, 13:00h to 17:00h ET. Virtual meeting.  Contact: Amanda Benedict.

Cleaning of Reusable Medical Devices Working Group (open web meeting). 31 March 2021, 11:30h to 15:30h ET. Virtual meeting.  Contact: Amanda Benedict.

April 2021

Sterilization Standards Meetings Closing Plenary/US TAG to ISO/TC 198 (open web meeting). 1 April 2021, 14:00h to 16:00h ET. Virtual meeting.  Contact: Amanda Benedict.

May 2021

Cardiac Rhythm Management Devices (open web meeting). 6 May 2021, 11:00h to 13:30h ET. Contact: Standards Department.

Renal Disease and Detoxification Committee (open web meeting). 7 May 2021, 11:00h to 17:00h ET. Contact: Cliff Bernier.

September 2021

AAMI Sterilization Standards meetings (open web meetings). 13-17 September 2021, 08:00h to 17:00h ET. Schedule of meetings TBD. AAMI, Arlington, VA.  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.

February 2021

ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 23 February 2021, 08:00 h to 10:00 h ET, Zoom meeting. Contact: Amanda Benedict

ISO/TC 198/WG 8, Microbiological methods (closed meeting), 24 February 2021, 09:00 h to 10:00 h ET, Zoom meeting. Contact: Amanda Benedict

March 2021

ISO/TC 198/WG 16, Vaporized hydrogen peroxide sterilization (closed meeting), 2, 4, 9, 11, 16, 18 March 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict

ISO/TC 198/WG 4, Biological indicators (closed meeting), 8 March 2021, 09:00 h to 12:00 h ET, Zoom meeting. Contact: Amanda Benedict

ISO/TC 198/WG 2, Radiation sterilization (closed meeting), 11 March 2021, 11:00 h to 12:00 h ET, Zoom meeting. Contact: Amanda Benedict

April 2021

ISO/TC 150/SC 2/WG 8, Cardiac occluders (closed meeting). 5 to 7 April 2021, Zoom meeting. Contact: Cliff Bernier

IEC/TC 62 and subcommittees, Electrical equipment in medical practice (closed meeting), 12 to 23 April 2021, Zoom meeting. Contact: Hae Choe

July 2021

ISO/TC 121, Anaesthetic and respiratory equipment (closed meeting), 16 July 2021, Zoom meeting. Contact: Colleen Elliott.

 

Miscellaneous

AAMI, in collaboration with the British Standards Institution, is launching an effort to develop standards for artificial intelligence (AI) and machine learning (ML) in medical technologies. In May of this year, AAMI published a whitepaper discussing the need for new standards and regulator initiatives to promote the safety, effectiveness, and availability of AI and ML in healthcare. (https://www.aami.org/detail-pages/press-release/aami-bsi-position-paper-sets-machine-learning-agenda)

There were seven recommendations made in the whitepaper. One of the most urgent was for guidance on applying ISO 14971, Medical Devices—Application of Risk Management to Medical Devices, when evaluating medical technology utilizing AI and, in particular, ML. AAMI and BSI have established a partnership to jointly develop a document which provides this guidance, as well as other needed AI standards identified in the whitepaper.

As a result of this initial work, AAMI is creating a new consensus body, tentatively call the AAMI Artificial Intelligence Committee (AAMI AI) to develop this work. Interested parties, including representatives of clinical practices, academia, regulatory authorities, and industry should contact standards@aami.org for more information about the project or participation on the committee.

 

Issues

January 29, 2021

January 8, 2021

December 4, 2020

November 13, 2020

October 23, 2020

October 2, 2020

September 11, 2020

August 21, 2020

July 31, 2020

July 10, 2020

May 22, 2020

May 1, 2020

April 10, 2020

March 20, 2020

February 28, 2020

 

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