AAMI Standards Monitor Online 25 June 2021
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:
NEW! AAMI TIR76:2021, Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S. Purchase here.
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 June 28, 2021
AAMI/ISO 13408-3, Aseptic processing of health care products—Part 3: Lyophilization (reaffirmation of an American National Standard). This standard specifies requirements for and offers guidance on equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process. Contact: Amanda Benedict
AAMI ST98, Cleaning validation of health care products — Requirements for development and validation of a cleaning process for medical devices (proposed new American National Standard). This standard covers the requirements to validate the cleaning instructions that are provided by the medical device manufacturer for processing medical devices. Contact: Amanda Benedict
Comments due July 5, 2021
AAMI ST91, Flexible and semi-rigid endoscope processing in healthcare facilities (revision of an American National Standard). This standard provides guidelines for point of use treatment, transporting, leak testing (where indicated), cleaning, packaging (where indicated), high-level disinfecting and/or sterilizing, storage, and quality control procedures of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, flexible ear, nose, and throat endoscopes, flexible urology endoscopes, and other types of reusable flexible endoscopes used in procedural and surgical settings, and semi-rigid operative endoscopes (e.g., choledochoscopes) used in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these reusable devices and accessories to render them safe for patient use. Contact: Amanda Benedict
Comments due July 19, 2021
AAMI CN27, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications (new American National Standard). CoversLuer activated valves (LAVs) for intravascular applications, which open and permit access to the fluid conduit when a male Luer connector is inserted. This standard applies only to the valve end of LAVs. This standard applies to LAVs as stand-alone devices or as components of a medical device. Contact: Colleen Elliott
AMI ST8, Hospital steam sterilizers (revision of an American National Standard). Applies to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (L) (2 cubic feet [ft3]). Contact: Cliff Bernier
AAMI ST55, Table-top steam sterilizers (reaffirmation of an American National Standard). Establishes minimum construction and performance requirements for small tabletop steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 56.63 liters (2 cubic feet). Contact: Cliff Bernier
AAMI/ISO 18472, Sterilization of health care products - Biological and chemical indicators - Test equipment (identical national adoption of ISO 18472:2018). Specifies the requirements for test equipment to be used to: - test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; - test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014. This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. Contact: Cliff Bernier
AAMI/ISO 5840-1, Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (identical national adoption of ISO 5840-1:2021 and revision of ANSI/AAMI/ISO 5840-1-2015). Applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. Applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. Contact: Cliff Bernier
AAMI/ISO 5840-2, Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (identical national adoption of ISO 5840-2:2021 and revision of ANSI/AAMI/ISO 5840-2-2015). Applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. Applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. Contact: Cliff Bernier
ISO 5840-3, Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (identical national adoption of ISO 5840-3:2021 and revision of ANSI/AAMI/ISO 5840-3-2012). Applicable to all devices intended for implantation as a transcatheter heart valve substitute. Applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. Contact: Cliff Bernier
AAMI/ISO 25539-2, Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (identical national adoption of ISO 25539-2:2020 and revision of ANSI/AAMI/ISO 25539-2-2012). Specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included. Contact: Cliff BernierAAMI/ISO 80369-6, Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications (reaffirmation of an American National Standard). Specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. Contact: Colleen Elliott
AAMI CN, Small bore connectors Committee. The committee is seeking user, regulatory and general interest members to participate in the development of AAMI/ISO 80369-1/Ed.3, Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements. 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: Ovidiu Munteanu
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 LewellingAAMI 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: AAMI Standards
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 (email@example.com) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
AAMI Packaging Working Group (open meeting). 28 June 2021, 11:00h to 15:00h ET. Virtual Meeting. Contact: Amanda Benedict
AAMI High Frequency Therapeutic Device Committee (open meeting). 06 July 2021, 15:00h to 17:00h ET. Virtual Meeting. Contact: Ladan Bulookbashi
AAMI Sterilization Standards meetings (open meetings). 13-17 September 2021, 08:00h to 17:00h ET. Schedule of meetings TBD. AAMI, Arlington, VA. Contact: Amanda Benedict
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 198/WG 3, Industrial moist heat sterilization (closed meetings), 28, 30 June 2021, 13:00 h to 16:00 h BST, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 9, Aseptic processing (closed meeting), 1 July 2021, 12:00 h to 16:00 h CEST, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 13 July 2021, 13:00 h to 15:00 h IST, Zoom meeting. Contact: Amanda Benedict
ISO/TC 121, Anaesthetic and respiratory equipment (closed meeting), 16 July 2021, Zoom meeting. Contact: Colleen Elliott
ISO/TC 150/SC 2/WG 5, Renal replacement, detoxification and apheresis (closed meeting). 20 July to 22 July 2021. Zoom meeting. Contact: Cliff Bernier
ISO/TC 198/WG 13, Washer-disinfectors (closed meeting), 22 July 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 13, Washer-disinfectors (closed meeting), 26 August 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 150/SC 2/WG 5, Renal replacement, detoxification and apheresis (closed meeting). 20 September to 24 September 2021. Zoom meeting. Contact: Cliff Bernier
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 firstname.lastname@example.org for more information about the project or participation on the committee.