diff --git a/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc b/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc index a04808c..7e9fb29 100644 --- a/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc +++ b/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc @@ -17,6 +17,13 @@ Ultimately, the content of this appendix may be rearranged and even relocated; h [bibliography] === Referenced Standards +[%noheader] +[%autowidth] +[cols="1"] +|=== +| *{supplement_note}*: The standards listed in this section are predominantly published. However, in the current version, three of them are unpublished drafts and are hence subject to requirement changes once they are published: <>, <> and <>. No content from those three standards - including their requirements - is normatively used in the current version. +|=== + * [[[ref_aami_2700_1_2019,AAMI 2700-1:2019]]] AAMI 2700-1:2019 Medical Devices And Medical Systems - Essential Safety And Performance Requirements For Equipment Comprising The Patient-Centric Integrated Clinical Environment (ICE) - Part 1: General Requirements And Conceptual Model, available at https://webstore.ansi.org/Standards/AAMI/ansiaami27002019[ANSI/AAMI web store]. * [[[ref_hl7_fhir,HL7 FHIR]]] HL7^®^ Fast Healthcare Interoperability Resources (FHIR^®^), available at http://hl7.org/fhir/[hl7.org/fhir/]. @@ -27,7 +34,7 @@ Ultimately, the content of this appendix may be rearranged and even relocated; h * [[[ref_iec_60601_1_8_2020,IEC 60601-1-8:2020]]], IEC 60601-1-8:2006/AMD2:2020, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; Amendment 1:2020, and Amendment 2:2020. available at https://webstore.iec.ch/publication/59648[IEC Webstore] and the https://www.iso.org/standard/41986.html[ISO standards store]. -* [[[ref_ieee_11073_10101_2020,IEEE 11073-10101:2020]]] IEEE 11073-10101™ International Standard - Health informatics--Device interoperability--Part 10101:Point-of-care medical device communication--Nomenclature. Available at hhttps://standards.ieee.org/ieee/11073-10101/10343/[IEEE online standards store]. +* [[[ref_ieee_11073_10101_2020,IEEE 11073-10101:2020]]] IEEE 11073-10101™ International Standard - Health informatics--Device interoperability--Part 10101:Point-of-care medical device communication--Nomenclature. Available at https://standards.ieee.org/ieee/11073-10101/10343/[IEEE online standards store]. * [[[ref_ieee_11073_10201_2004,IEEE 11073-10201:2004]]] IEEE 11073-10201™ International Standard - Health informatics--Device interoperability--Part 10201:Point-of-care medical device communication--Domain information model. Note this was updated in 2020. Available at https://standards.ieee.org/ieee/11073-10201/10263/[IEEE online standards store].