ISO 80369 PDF

To learn about ISO and small bore connector standards, visit our website for ISO standard information and shop our products today. ISO is the newly published standard that replaces the ISO series of standards. The ‘Part 7’ standard is specifically for small-bore. intravasculaires ou hypodermiques. STANDARD. ISO. First edition. Reference number. ISO (E). Corrected version.

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

May, Update Below is an update on the ISO initiative for medical device small bore connectors. The new standard has changed the configuration of the male and female jso.

What Is ISO ? – American Society of Regional Anesthesia and Pain Medicine

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. A new draft standard will go out for circulation, within the next two months. A final design is available and the global body is coming around to accept that there may not be a better solution DIS is now out for ballot and closes on February 83069, The law passed in California means there is only about 2 years left for Enteral and Neuraxial to get their connector standards approved and isl incorporating these connectors completed.

Here is a synopsis of the meeting: Future Changes for Urinary Catheters Urethral applications involve the urinary catheters that are used to drain the bladder. Reducing risk in intravenous kso is the aim of new standard Intravenous delivery of medication or other vital products can save lives. A new draft standard will go out for circulation, likely before the end of February.

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There continues to be three connector sets in the standard, as described previously. Commencing January 1,a health facility, as defined in subdivision abcor f of Sectionis prohibited from using an epidural connector that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.

A separate computer aided design CAD committee has been 80396 as a part of the process of developing the individual connector standards to analyze proposed standard connectors for possible connection to a luer, and also to connectors defined in parts 2 to 6. Nordson Medical is manufacturing prototype connectors for functional testing to the standard.

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

ISO Standards on enteral feeding systems

Intravascular or Hypodermic Committee is considering FDIS ballot in and this standard could publish in late The group agreed to survey manufacturers with the intent to narrow the range on the internal diameter of the male luer and the external diameter of the male luer collar. California law AB states: Established a task group to review how each part will satisfy Part 1, sub clause 7. Administration sets and syringes have a female connector end that fit into a male patient-access feeding tube port.

No further changes were requested for these parts. It also specifies the healthcare fields in which these small-bore connectors are intended to be used. Connectors for the delivery of nutrients through feeding tubes.

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How does this affect you?

ISO I Small Bore Connectors | Qosina

The PG2 Respiratory standards committee did not meet. Monday to Friday – Note The PG2 Respiratory standards committee did not meet. Contact us to schedule an appointment with our knowledgeable staff. These healthcare fields include, but are not limited to: It is unclear how this testing will be done and who will pay 803669 it.

What is ISO ? The discussion centered around two key things among others. Bag Ports Test Data.

Intravascular 8036 Hypodermic The goal is to lock the luer dimensions so the other groups can move forward 8036 has several dimensions that are very broad in scope CAD experts met to resolve conflicting dimensions that could result in misconnections PG7 will issue a 803369 for balloting and comments after January 31, Further Discussions A task group was established to determine how testing is to be specified in each part with respect to Part 1 — Annex B Established a task group to review how each part will satisfy Part 1, sub clause 7.

This has already been conducted for -3 by a private usability group and for -5 and -7 from a historical use perspective. Toward this end much discussion took place regarding which dimensions are controlled by the standard and which are not.

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