Skip to main content
Back

EVS-EN 15986:2011

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

General information

Valid from 05.04.2011
Base Documents
EN 15986:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
05.04.2011
Main
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041. This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.

Required fields are indicated with *

*
*
*
PDF
12.20 € incl tax
Paper
12.20 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 9001:2015 en

Quality management systems - Requirements (ISO 9001:2015)
Newest version Valid from 06.10.2015
Main + amendment

EVS-EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices
Withdrawn from 17.05.2021
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN 556-1:2002

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices.
Withdrawn from 15.07.2024