AAMI Standards Monitor Online 23 October 2020
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:
Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment. Purchase here.
Risk management guidance for combination products. Purchase here.
Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment. Purchase here.
Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters. Purchase here.
Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation. Purchase here.
Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. Purchase here.
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. Purchase here.
Published documents proposed for reaffirmation can be purchased from the AAMI Store.
Comments due October 26, 2020
AAMI PC76, Active implantable medical devices – Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging (proposed new American National Standard). Provide requirements and test protocols for implantable pacemakers and ICDs exposed to magnetic resonance imaging. Physicians are increasingly using magnetic resonance imaging as tool for differential diagnostic, thus exposing pacemakers and ICD patients to such equipment. Current product standards for implantable pacemakers and ICDs do not include requirements and test protocols for implantable pacemakers and ICDs, which would ensure patient safety during such procedures. Contact: jmoyer@aami.org
Comments due November 9, 2020
AAMI HIT1000-1, AAMI HIT1000-1/Ed 1, Health IT Software and Systems – Part 1: Fundamental concepts and principles (proposed new American National Standard from a provisional standard). Identifies the fundamental concepts and principles needed to maintain safe, secure and effective health IT software and systems. Identifies the roles, and defines the responsibilities, activities and best practices that are necessary for managing safety, security and effectiveness of health IT software and systems. Applies throughout the whole lifecycle of health IT software and systems and to all sizes and type of actors involved with that system. Contact: EHoefer@aami.org
Comments due November 16, 2020
AAMI/IEC 60601-2-20, Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (proposed revised American National Standard). Applies to the basic safety and essential performance of transport incubators. This standard does not apply to heating devices intended for physiotherapy, baby incubators, radiant warmers. Contact: jmoyer@aami.org
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: 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 II, Infant Incubators. The committee will be working on the identical expedited adoption of the following documents:
To get involved in the development of these documents, please contact Jennifer Moyer.
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 (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.
Please click below to view the October 2020 AAMI Sterilization standards meetings
Sterilization Standards Metings
October 2020
November 2020
Information on draft international standards under ballot can be found in ANSI Standards Action.
International Committee and Working Group MeetingsCall or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
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.