• There are no items in your cart

I.S. EN 13532:2002

Current

Current

The latest, up-to-date edition.

GENERAL REQUIREMENTS FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2002

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

€33.00
Excluding VAT

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design criteria
5 Markings and information supplied by the manufacturer
6 Performance evaluation
7 User verification
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing.

DocumentType
Standard
Pages
9
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
UNE-EN 13532:2002 Identical
BS EN 13532:2002 Identical
UNI EN 13532 : 2002 Identical
EN 13532:2002 Identical
DIN EN 13532:2002-08 Identical

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.