CEN/TC 204/WG 8 - Aseptic processing of medical devices
Preparation of standards relating to the validation and routine monitoring of processes used in the manufacture of aseptic medical devices. Standardization of aseptic processes used for medical devices.
Aseptic processing of medical devices
Preparation of standards relating to the validation and routine monitoring of processes used in the manufacture of aseptic medical devices. Standardization of aseptic processes used for medical devices.
General Information
Frequently Asked Questions
CEN/TC 204/WG 8 is a Working Group within the European Committee for Standardization (CEN). It is named "Aseptic processing of medical devices" and is responsible for: Preparation of standards relating to the validation and routine monitoring of processes used in the manufacture of aseptic medical devices. Standardization of aseptic processes used for medical devices. This committee has published 1 standards.
CEN/TC 204/WG 8 develops CEN standards. The scope of work includes: Preparation of standards relating to the validation and routine monitoring of processes used in the manufacture of aseptic medical devices. Standardization of aseptic processes used for medical devices. Currently, there are 1 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable.
NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.
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