Health

ISO 80369 1 PDF

Partie 1: Exigences générales. STANDARD. ISO. Second edition. Reference number. ISO (E). Provläsningsexemplar / Preview. ISO contains the following major technical revisions to the previous ISO and ISO standards: The addition of new terms. The culmination of their work, ISO , was published in January The sweeping standard provides general connector requirements.

Author: Tygoll Bashicage
Country: Kuwait
Language: English (Spanish)
Genre: Technology
Published (Last): 6 September 2018
Pages: 35
PDF File Size: 16.27 Mb
ePub File Size: 12.11 Mb
ISBN: 215-9-24564-187-8
Downloads: 41806
Price: Free* [*Free Regsitration Required]
Uploader: Akinozshura

BS EN ISO 80369-1:2010

Such requirements are given in particular International Standards for specific medical devices or accessories. It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse.

These small-bore connectors are used in medical devices or accessories intended for use with a patient. Connectors for limb cuff inflation applications – Part 6: Small-bore connectors as specified in ISO Proof sent to secretariat or FDIS ballot initiated: ISO Small-bore connectors for liquids and gases in healthcare applications — Part 1: ISO Scope Notes – NOTE 1 It is intended that new designs of small-bore connectors will be included in this series of standards after they have been assessed according to the procedure given in Clause 6.

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards.

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences.

ISO Small-bore Connectors in Healthcare Applications

Fluids handling equipment medicalPipe connections, Safety measures, Medical breathing apparatus, Small, Medical equipment, Parenteral infusion equipment, Blood transfusion equipment, Gases, Risk assessment, Catheters, Liquids, Drug administration, Conical fittings syringes. Accept and continue Learn more about the cookies we use and how to change your settings.

  IC SG3525 DATASHEET PDF

Reducing risk in intravenous delivery is the aim of new standard Intravenous delivery of medication or other vital products can save lives. It does not specify requirements for the medical devices or accessories that use these small-bore connectors.

Live Chat Powered by jivochat. ISO Introduction In the s concern grew regarding the proliferation of medical devices fitted with Luer connectors and the reports of patient death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.

iiso This series of standards is being developed in such a way that ISO includes general requirements to prevent misconnections between small-bore connectors used in different applications. Monday to Friday – Gage Crib Worldwide, Inc.

ISO 80369 Series – Small-bore connectors

Such requirements are given in particular International Standards for specific medical devices or accessories. We use cookies to make our website easier to use and to better understand your needs. Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories. The faster, easier way to work with standards. July Replaced By: These healthcare fields include, but are not limited to: It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors as specified in the series of standards will be included.

A new standard 803699 connectors with intravenous or hypodermic applications has just been published, complementing the series Connectors for neuraxial applications – Part 7: Proof sent to secretariat or FDIS ballot initiated: The intention is to provide accurate information; regardless; errors may exist in the supplied information.

  GAPEKA 2015 PDF

This principle is embodied in the requirements of numerous medical device standards. You may be interested ieo This International Standard also specifies the healthcare fields in which these small-bore connectors are intended to be used. ISO Scope This Part 1 of ISO specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications.

ISO Series – Small-bore connectors

It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO series of standards will be considered. However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. Final text received or FDIS registered 8039 formal approval.

In a coronary care unit there are as many as 40 Luer connectors on the medical devices used with a single patient. Search all products by. These small-bore connectors are used in medical devices medical devices or accessories intended for use with a ido.

ISO Foreword This part 1 of this International Standard contains general requirements to ensure the prevention of misconnection between small-bore connectors used in different applications. You may experience issues viewing this site in Internet Explorer 9, 10 or Monday to Friday – This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities.

Such requirements are given in particular International Standards for specific medical devices or accessories.