ANSI Seeks Comments: Systematic Review of ISO/IEC Guide 63-2019 on the Development and Inclusion of Aspects of Safety in International Standards for Medical Devices

Feedback Requested by October 18, 2024

As the U.S. member body to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC), the American National Standards Institute (ANSI) is seeking comments on a systematic review of ISO/IEC Guide 63-2019, Guide to the development and inclusion of aspects of safety in international standards for medical devices. Input is requested by October 18, 2024.

ISO/IEC Guide 63-2019 was prepared by a Joint Working Group of ISO Technical Committee (TC) 210, Quality management and corresponding general aspects for medical devices, and IEC Subcommittee (SC) 62A, Common aspects of electrical equipment used in medical practice. It has the following scope statement:

• This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in international standards, based on well-established risk management concepts and methodology.

   

• This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.

   

• In this document, the term “product” includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.

ISO has initiated a systematic review of the document; this third edition replaces the second edition (ISO/IEC Guide 63:2012), which has been technically revised. Read the document to review the main changes compared with the previous edition.

Submit comments to Steven Cornish, ANSI senior director of international policy and strategy ([email protected]) by close of business on October 18. Based on the input received from U.S. stakeholders, a recommended ANSI position and any comments will be developed and presented to the ANSI ISO Council (AIC) for approval before the ISO voting deadline of December 2.