| Publication CODE |
Title |
| NBN EN ISO 15223-1:2016 (2016-11) |
MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
32.00 €
|
11 P.. |
Description
ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.
|
| 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.
|
|
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
Replaces
NBN EN ISO 15223-1:2012
|
|
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
| BEC Approval |
2016-10-22 |
| NBN Approval |
2016-12-21 |
| Belgian Official Journal |
2017-01-26 |
| Registration |
176354 |
| Numbers identifying the european directives |
90/385/EEC
(Active implantable medical devices)
93/42/EEC
(Medical devices)
98/79/EC
(In vitro diagnostic medical devices)
|
| ICS-Code (International Standards Classification) |
01.080.20
, 11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2016-10-22 |
| Date of availability (d.a.v.) |
2016-11-30 |
| Date of announcement (d.o.a.) |
2017-02-28 |
| Date of publication (d.o.p.) |
2017-05-31 |
| Date of withdrawal former edition (d.o.w.) |
2017-05-31 |
|
