©ISO 2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Appareils électromédicaux — Partie 2-56
2019/06/24 ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 80601-2-55 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments … ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents. If a clause or subclause is specifically intended to be applicable to me equipment only or to me systems only, the title and … ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient. ISO 80601-2-55 : 2011 Withdrawn Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and IEC 60601-2-49：2011 208.6 ALARM SYSTEMS IEC 60601-1-8:2006 1.3.2 Particular standards 6 ALARM SYSTEMS ② 生体情報計測機能 下記の生体情報項目等を有する場合、既存品との同等性評価を行うこと。 （ア）心電図
2009/12/08 ISO 80601-2-56:2017 does not apply to auxiliary equipment. ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56 ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2017. PDFダウンロード 書籍 セミナー 検索 関連サイト 日経クロステック Active 日経電子版 関連サイト／サービス一覧 医療体温計向け規格「ASTM E1112」や、国際標準化機構（ISO）の医療用電気機器向け規格「ISO 80601-2-56」に ISO 80601-2-72:2015 NS-EN ISO 80601-2-79:2019 NS-EN ISO 80601-2-80:2019 Standardisation Norsk Standard Norsk Spesifikasjon Committees Hvordan lages standarder? Standarder og regelverk CE-merking ISO-standarder TI の TMP117EVM 評価モジュール（評価ボード）は、設計をプロトタイプから生産に移行するのに役立ちます。EVM の説明と特長は、サポート文書とリソースとともに記載さ …
(pdfダウンロード 917kb) 認定規格 アイピーエス新横浜安全センターは，株式会社電磁環境試験所認定センター(VLAC)より下記の医用電気機器，体外診断用医療機器，測定用・制御用及び試験所用電気機器規格のISO/IEC 17025の認定を取得しており，ILAC MRA 認定 JIST80601-2-55:2014の規格は,患者に対する連続作動を意図した呼吸ガスモニタ(RGM)の基礎安全及び基本性能に関する個別要求事項について規定。JIS改正最新更新日 ,英語訳 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors,対応国際規格ISO ISO 80601 tmp117は高精度のデジタル温度センサであり、astm e1112およびiso 80601の電子医療体温計の要件を満たすように設計されています。 較正不要で、-20°C～50℃の温度範囲にわたって0.0078℃の分解能、最大±0.1℃の精度で16ビットの温度結果を提供します。 (pdfダウンロード 917kb) iso/en iso 80601-2-55: jis t 80601-2-55: 呼吸ガスモニタ: iso/en iso 80601-2-56 国際標準化機構 (ISO) では、パルスオキシメータの標準規格として、ISO 80601-2-61:2011「Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 医用電気機器 - パート2-61：パルスオキシメータ機器の基礎安全および −40〜＋50℃の温度範囲における測定誤差は±0.15℃、−40〜＋100℃では±0.2℃、−55〜＋125℃では±0.25℃、−55〜＋150℃では±0.3℃である。pt（白金）を使った測温抵抗体（rtd）と同等の測定精度を実現できるという。 jis t 0601-1-2 第1-2 部：安全に関する一般的要求事項－電磁両立性－要求事項及び試験 jis t 0601-1-3 第1-3 部：基礎安全及び基本性能に関する一般要求事項－副通則：診断用x 線装置に おける放射線防護 t 0601-1：
ISO 80601-2-72:2015 NS-EN ISO 80601-2-79:2019 NS-EN ISO 80601-2-80:2019 Standardisation Norsk Standard Norsk Spesifikasjon Committees Hvordan lages standarder? Standarder og regelverk CE-merking ISO-standarder
ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient. ISO 80601-2-55 : 2011 Withdrawn Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and IEC 60601-2-49：2011 208.6 ALARM SYSTEMS IEC 60601-1-8:2006 1.3.2 Particular standards 6 ALARM SYSTEMS ② 生体情報計測機能 下記の生体情報項目等を有する場合、既存品との同等性評価を行うこと。 （ア）心電図 2017/03/24 ISO 80601-2-56 ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general