DS/EN 556-2:2015

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 45.86
Legislation:

Legislation

Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.

NOTE – For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.



Number of pages: 18

Published: 2015-12-10

Date of approval: 2015-09-25

International relationships : EN 556-2:2015 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: M283696


Committees

Committee

  • CEN/TC 204
  • CEN/TC 204/WG 6

Danish committee

DS/S-259