BS EN ISO 80601-2-61:2026 - TC
Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment
Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 июня 2026 г.
- ICS:
- 11.040.10
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 80601-2-61:2026 - TC
Abstract
201.1 Scope, object, and related standards IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in AA.2.1.
This document applies to the basic safety and essential
performance of pulse
oximeter equipment intended for use on humans, hereafter referred to as ME
equipment . This includes any part necessary for normal use , including the pulse oximeter
monitor , pulse oximeter probe , and probe cable extender .
These requirements apply to pulse oximeter equipment , including pulse oximeter monitors , pulse oximeter
probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).
The intended use of <i class="italic" id="d2...
Похожие стандарты
Упомянутые в описании и другие стандарты BS
IEC 60601-1:2005
ДействующийMedical electrical equipment - Part 1: General requirements for basic safety and essential performance
Overview IEC 60601-1:2005 (Consolidated Edition 3.1, with Amendment 1) is the international safety standard for medical electrical equipment, defining the general requirements for basic safety and es…
BS ISO 10835:2007
ДействующийDirect reduced iron and hot briquetted iron. Sampling and sample preparation.
1 Scope This International Standard gives a) the underlying theory, b) the basic principles for sampling and preparation of samples , and c) the basic requirements for the design, installation and op…