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ČSN EN IEC 60601-2-76 (364800)
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
Translate name
STANDARD published on 1.7.2019
The information about the standard:
Designation standards: ČSN EN IEC 60601-2-76
Classification mark: 364800
Catalog number: 505534
Publication date standards: 1.7.2019
SKU: NS-953008
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN IEC 60601-2-76 (364800):
minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of low energy ionized gas haemostasis equipment.
This particular standard amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, hereinafter referred to as the general standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.
A "Particular guidance and rationale" section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex AA.
Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an asterisk (*).
It is considered that knowledge of the reasons for these requirements will not only facilitate the proper appli-cation of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this document
These changes apply to this standard:
ČSN EN IEC 60601-2-76:2019/A1 (364800)
Change
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Zdravotnické elektrické přístroje - Část 2-76: Zvláštní požadavky na základní bezpečnost a nezbytnou funkčnost přístrojů pro koagulaci nízkoenergetickým ionizovaným plynem (Norma k přímému použití jako ČSN).
Change published on 1.3.2024
Selected format: English - Print design (9.20 USD)
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