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.

Comments due April 26, 2021

AAMI/ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (reaffirmation of an American National Standard). This standard specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g., instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Contact: Amanda Benedict

AAMI/ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (reaffirmation of an American National Standard). This standard specifies performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (e.g., instruments and porous loads). Contact: Amanda Benedict

AAMI/ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests (reaffirmation of an American National Standard). This standard specifies the requirements for an indicator and alternative test system used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.. Contact: Amanda Benedict

AAMI ST15883-2, Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc (reaffirmation of an American National Standard). This standard specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. Contact: Amanda Benedict

AAMI ST15883-3, Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (reaffirmation of an American National Standard). This standard specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. Contact: Amanda Benedict

AAMI/ISO 17664-2, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (expedited national adoption of an international standard). This standard specifies requirements for the information to be provided by the medical device manufacturer for the processing of medical devices not intended for direct patient contact. This includes information for processing prior to use or reuse of the medical device. Contact: Amanda Benedict

AAMI/ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (reaffirmation of an American National Standard). This standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. Contact: Amanda Benedict

Comments due May 17, 2021

AAMI ST15883-1, Washer-disinfectors, Part 1: General requirements, terms and definitions and tests & A1 & A2 (reaffirmation of an American National Standard and amendments). This standard specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. Contact: Amanda Benedict

AAMI SW96, Standard for medical device security — Security risk management for device manufacturers (proposed new American National Standard). This standard provides requirements and guidance when addressing design, production and post-production security risk management within the risk management framework defined by ANSI/AAMI/ISO 14971. While it is based on the ANSI/AAMI/ISO 14971 framework for medical device risk management, most concepts are applicable to any healthcare product, including digital health, that requires the management of security. Contact: Ovidiu Munteanu

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: 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 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.