SI 60601第2.4部分－醫(yī)用電氣設(shè)備：心臟除顫器的基本安全和基本性能特殊要求

頁數(shù)：使用語言：
鏈接網(wǎng)址：

內(nèi)容簡述：

The following communication, dated 5 October 2020, is being circulated at the request of the delegation of Israel.

Title: SI 60601 part 2.4 - Medical electrical equipment: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Reason for Addendum:
[ ]	Comment period changed - date:
[ ]	Notified measure adopted - date:
[X]	Notified measure published - date: 17 May 2020
[X]	Notified measure enters into force - date: 16 July 2020
[X]	Text of final measure available from: Publication in Israel Official Gazette, Section of Government Notice no. 8563, published on 17 May 2020. https://members.wto.org/crnattachments/2020/TBT/ISR/final_measure/20_5943_00_x.pdf
[ ]	Notified measure withdrawn or revoked - date: Relevant symbol if measure re-notified:
[ ]	Content or scope of notified measure changed New deadline for comments (if applicable):
[ ]	Interpretive guidance issued and text available from1:
[ ]	Other:

Description: The revision of the Mandatory Standard SI 60601 part 2.4 dealing with cardiac defibrillators, was published on 17 May 2020 and had entered into force on 16 July 2020.

Both the old standard and the newly revised standard will apply from entry into force until 11 October 2022. During this time, products may be tested according to the old or the new revised standard.

目的和理由：

相關(guān)文件：

擬批準(zhǔn)日期：
擬生效日期：

10.

意見反饋截至日期：

11.

文本可從以下機(jī)構(gòu)得到：

SI 60601第2.4部分－醫(yī)用電氣設(shè)備：心臟除顫器的基本安全和基本性能特殊要求

The following communication, dated 5 October 2020, is being circulated at the request of the delegation of Israel.

Title: SI 60601 part 2.4 - Medical electrical equipment: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Reason for Addendum:
[ ]	Comment period changed - date:
[ ]	Notified measure adopted - date:
[X]	Notified measure published - date: 17 May 2020
[X]	Notified measure enters into force - date: 16 July 2020
[X]	Text of final measure available from: Publication in Israel Official Gazette, Section of Government Notice no. 8563, published on 17 May 2020. https://members.wto.org/crnattachments/2020/TBT/ISR/final_measure/20_5943_00_x.pdf
[ ]	Notified measure withdrawn or revoked - date: Relevant symbol if measure re-notified:
[ ]	Content or scope of notified measure changed New deadline for comments (if applicable):
[ ]	Interpretive guidance issued and text available from1:
[ ]	Other:

Description: The revision of the Mandatory Standard SI 60601 part 2.4 dealing with cardiac defibrillators, was published on 17 May 2020 and had entered into force on 16 July 2020.

Both the old standard and the newly revised standard will apply from entry into force until 11 October 2022. During this time, products may be tested according to the old or the new revised standard.

通報(bào)原文：

附件：

[{"filename":"isr1106a1.docx","fileurl":"/upload/2021/note_attachfiles/300228/attachfiles/isr1106a1.docx","truename":"廖美嫻","uploadtime":"2021-08-18 15:34:36","userid":"80"}]

相關(guān)通報(bào)：

G/TBT/N/ISR/1106 SI 60601第2.4部分－醫(yī)用電氣設(shè)備：心臟除顫器的基本安全和基本性能特殊要求

我要評(píng)議