Publication details
| Publication CODE |
Title |
| NBN EN ISO 80369-3:2016 (2016-08) |
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES in HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO 80369-3:2016) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
70.00 €
|
58 P.. |
Description
ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.
NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.
It does not specify the dimensions and 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.
It does not specify requirements for small-bore connectors that are used for the following:
- gastric suction-only medical devices;
- oral-only medical devices;
EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.
- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;
- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;
- gastrointestinal endoscopy equipment;
- skin level gastrostomy medical devices.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices 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 ISO 80369, will be included.
|
| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered here:
ISO 80369-3:2016.
For the series NBN EN 50XXX, the standards are however complete.
|
DE version
|
EN version
|
FR version
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
Origin
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
Approval
| BEC Approval |
2016-05-25 |
| NBN Approval |
2016-09-23 |
| Registration |
176160 |
| ICS-Code (International Standards Classification) |
11.040.25
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2016-05-25 |
| Date of availability (d.a.v.) |
2016-08-10 |
| Date of announcement (d.o.a.) |
2016-11-30 |
| Date of publication (d.o.p.) |
2017-02-28 |
| Date of withdrawal former edition (d.o.w.) |
2017-02-28 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN ISO 80369-3:2016
|
2016-08-10 |
| is identical to |
ISO 80369-3:2016/ed. 1.0
|
2016-07-01 |
|
