| Publication CODE |
Title |
| NBN EN ISO 15223-1:2012 (2016-11) |
MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED
PART 1: GENERAL REQUIREMENTS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
67.00 €
|
13 P. |
Description
This part of ISO 15223 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 part of ISO 15223. This part of ISO 15223 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 part of ISO 15223 are not intended to apply to symbols specified in other standards.
|
| Class |
C
|
Available files
Not available under electronic format.
The publication in paper format can be ordered << here >>.
|
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Withdrawn
Replaced by
NBN EN ISO 15223-1:2016
|
|
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
| BEC Approval |
2012-05-24 |
| NBN Approval |
2012-08-31 |
| Belgian Official Journal |
2012-10-26 |
| Registration |
156123 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
90/385/EEC
(Active implantable 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.) |
2016-11-30 |
| Date of availability (d.a.v.) |
2016-11-30 |
| Date of announcement (d.o.a.) |
2012-10-31 |
| Date of publication (d.o.p.) |
2013-01-31 |
| Date of withdrawal former edition (d.o.w.) |
2015-07-01 |
|
