IEC 60601-2-20 Ed. 3.1:2023 (b)
医用電気機器－第2-20部：搬送保育器の基礎安全及び基本性能の特定要求事項
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
発行年月日：
2023-11-09
状態：
有効
邦訳版：
無
英語 195ページ
104,912 円（税込） 本体価格：95,375円
- 規格概要
-
IEC 60601-2-20:2020+AMD1:2023 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-20:2020 specifies safety requirements for INFANT TRANSPORT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.全文を表示する
This particular standard does not apply to:
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50.
IEC 60601-2-20:2020 constitutes a technical revision. IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
| TC |
TC 62/SC 62D |
|---|---|
| ICS |
11.040.10 |
| 備考 |
