September, 2016 IEEE/HL7 Baltimore, USA ISO/IEEE 11073 ISO Comments September, 2016 IEEE/HL7 Baltimore, USA

Comments on -10417 SE Entire document Ge ISO began it’s operations 1947. Since then 19 500 standards have been published. One explanation why ISO-standards are globally accepted and used is the process under which the standards are developed. Every medical device put on market meets the requirements in internationally accepted standards i.e. ISO standards. To assure patient safety and function, standards related to software have to be in line with other standards. The format and the lack of transparent process of this document can risk both patient safety and function even if the content and intention of the document is good. Start a revision immediately and rewrite the document under the ISO process and the ISO format. As written, this document can’t be considered as an international standard. It contains disclaimers and text that is irrelevant in international standards Rewrite the entire document in the ISO format and delete all irrelevant text. Before clause 1 Te A standard covering medical devices has to have focus on patient safety. This standard clearly determines that “IEEE Standards documents are not intended to ensure safety, health, or environmental protection, or ensure against interference with or from other devices or networks” A user that intends to use this document as a “standard” when developing a medical device will most certainly undertake a big risk in developing a product with built in patient safety risks and bad compatibility with other products. Rewrite the document in a way that patient safety aspects are covered and make references to other relevant ISO standards i.e. ISO 14971.   319 SW Pine Street Portland, Oregon 97204 USA Main Phone: + 1-503-279-9000

IEEE Text before clause 1.0 IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection. Implementers of the standard are responsible for determining appropriate safety, security, environmental, and health practices or regulatory requirements. 319 SW Pine Street Portland, Oregon 97204 USA Main Phone: + 1-503-279-9000

IEEE Text added in -30400 4.5 Compliance with other standards Devices that comply with this standard may also be required to comply with other domain- and device-specific standards that supersede the requirements of this standard and IEEE Std 802.3-2008 to which this standard refers with respect to issues including safety, reliability, and risk management. A user of this standard is expected to be familiar with all other such standards that apply and to comply with any higher specifications thus imposed. Typically, medical devices will comply with the IEC 60601-1:1999 [B1] base standards and its parts, such as IEC 60601-1-1:2000 [B2], with respect to electrical and mechanical safety and any device specific standard as might be defined in IEC 60601-2-XX:YEAR [B3]. Subclause 4.1 of this standard provides a description of the context within which devices that comply with this standard function. 319 SW Pine Street Portland, Oregon 97204 USA Main Phone: + 1-503-279-9000

IEEE Text added in -30400 4.5 Compliance with other standards Devices that comply with this standard shall implement higher layers of network software as appropriate to the application. The requirements on performance of such applications and conformance are defined elsewhere and are outside the scope of this standard. Additionally, the network environment within which devices operate should be specified. Use of any medical equipment within a network environment shall be subject to risk assessment and risk management appropriate to the application and use and should adhere to standards such as ISO 14971:2007 [B6] and IEC 80001-1 [B5]. The requirements of such risk assessment and risk management and conformance are outside the scope of this standard. 319 SW Pine Street Portland, Oregon 97204 USA Main Phone: + 1-503-279-9000