Hivatkozási szám

MSZ EN 80369-5:2017

Dokumentumazonosító

165327

Cím

Egészségügyi használatú, kis belső átmérőjű csatlakozók folyadékokhoz és gázokhoz. 5. rész: Csatlakozók végtagmandzsetta-felfújó alkalmazásokhoz (IEC 80369-5:2016)

Angol cím

Small-bore connectors for liquids and gases in healthcare applications. Part 5: Connectors for limb cuff inflation applications (IEC 80369-5:2016)

Alkalmazási terület

This part of International Standard 80369 specifies dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES. Limb cuff inflation APPLICATIONS include CONNECTIONS between a sphygmomanometer and its cuff. [3] [7] 1 This part of International Standard 80369 does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. This part of International Standard 80369 does not specify requirements for pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive MEDICAL DEVICES in place. NOTE 1 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of International Standard 80369 into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS, as specified in this part of International Standard 80369, will be included. NOTE 2 The requirements for SMALL-BORE CONNECTORS intended to be used with neonatal PATIENTS to connect a cuff to a sphygmomanometer are intended to be added to this standard by an amendment or new edition. IEC 80601-2-30 [7] defines the age range for neonatal mode usage of sphygmomanometers. NOTE 3 The requirements for SMALL-BORE CONNECTORS intended to be used to connect a tourniquet to its inflating equipment are intended to be added to this standard by an amendment or new edition. NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for SMALLBORE CONNECTORS intended for limb cuff inflation APPLICATIONS of MEDICAL DEVICES or ACCESSORIES which do not comply with this part of ISO 80369.

ICS

11.040.25 Fecskendők, tűk és katéterek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2017-06-01

Forrás

idt IEC 80369-5:2016; idt EN 80369-5:2016/AC:2017; idt EN 80369-5:2016; idt EN 80369-5:2016/AC:2021; idt IEC 80369-5:2016/COR2:2021-05

Előd

Utód

Módosítás

SZK-közlemények

2017/07: Helyesbítés; 2021/08: Helyesbítés

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

A szabvány

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