ISO/TC 121/SC 3
| Project No. | ISO 18778:2022 |
|---|---|
| Title | <p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of an <em>infant cardiorespiratory monitor,</em> as defined in 3.10, hereafter also referred to as <em>ME equipment,</em> in combination with its <em>accessories</em>:</p> <p>— intended for use in the <em>home healthcare environment</em>;</p> <p>— intended for use by a <em>lay operator</em>;</p> <p>— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and</p> <p>— intended for <em>transit-operable</em> use.</p> <p>NOTE An <em>infant cardiorespiratory monitor</em> can also be used in professional health care facilities.</p> <p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to the <em>infant cardiorespiratory monitor</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>infant cardiorespiratory monitor</em>.</p> <p>EXAMPLE probes, cables <em>distributed alarm system</em></p> |
| Registration number (WIID) | 79357 |
| Scope | <p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of an <em>infant cardiorespiratory monitor,</em> as defined in 3.10, hereafter also referred to as <em>ME equipment,</em> in combination with its <em>accessories</em>:</p> <p>— intended for use in the <em>home healthcare environment</em>;</p> <p>— intended for use by a <em>lay operator</em>;</p> <p>— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and</p> <p>— intended for <em>transit-operable</em> use.</p> <p>NOTE An <em>infant cardiorespiratory monitor</em> can also be used in professional health care facilities.</p> <p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to the <em>infant cardiorespiratory monitor</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>infant cardiorespiratory monitor</em>.</p> <p>EXAMPLE probes, cables <em>distributed alarm system</em></p> |
| Status | Standarts spēkā |
| ICS group | 11.040.10 11.040.55 |