Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

STANDARD

Current

ÖNORM EN ISO 13408-6

Issue date: 2021 10 15

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.

read more

General information on ÖNORM EN ISO 13408-6

Format

Digital | 42 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 215 Sterilization and disinfection of medical devices

Timeline

An overview of the development of ÖNORM EN ISO 13408-6 from 2005 til today.

• ÖNORM EN ISO 13408-6

  2021 10 15 Standard ÖNORM EN ISO 13408-6, Edition: 2021 10 15

  Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
• ÖNORM EN ISO 13408-6

  2013 12 01 Standard ÖNORM EN ISO 13408-6, Edition: 2013 12 01

  Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013...
• ÖNORM EN ISO 13408-6

  2011 09 15 Standard ÖNORM EN ISO 13408-6, Edition: 2011 09 15

  Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
• ÖNORM EN 13824

  2005 02 01 Standard ÖNORM EN 13824, Edition: 2005 02 01

  Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Read more

Frequently Asked Questions about ÖNORM EN ISO 13408-6

What is a "Single-User Licence"?

When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.

Find out more about the benefits of multi-user licences

How can I get involved in the further development of this standard?

Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.

Find out more about getting involved in standardization

How can I manage my standards efficiently?

If you have an extensive portfolio of standards, we recommend using a professional standards management tool. With effects 2.0, you can manage your standards centrally and efficiently. You can optimise your procurement processes and benefit from an integrated information and subscription service. This ensures you are always up to date and never miss any relevant developments.

Find out more about the benefits of effects 2.0

Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 11139:2018	Titel Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards	Ausgabedatum 2018 08 03	Art Standard	Zur Produktseite
Dokumentnummer ISO 13408-1:2008	Titel Aseptic processing of health care products — Part 1: General requirements	Ausgabedatum 2008 06 10	Art Standard	Zur Produktseite
Dokumentnummer ISO 13408-4:2005	Titel Aseptic processing of health care products — Part 4: Clean-in-place technologies	Ausgabedatum 2005 10 28	Art Standard	Zur Produktseite
Dokumentnummer ISO 13408-7:2012	Titel Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products	Ausgabedatum 2012 07 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 14644-1:2015	Titel Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration	Ausgabedatum 2015 12 09	Art Standard	Zur Produktseite
Dokumentnummer ISO 14644-7:2004	Titel Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)	Ausgabedatum 2004 10 07	Art Standard	Zur Produktseite
Dokumentnummer ISO 18362:2016	Titel Manufacture of cell-based health care products — Control of microbial risks during processing	Ausgabedatum 2016 01 15	Art Standard	Zur Produktseite
Dokumentnummer ISO/IEC 90003:2014	Titel Software engineering — Guidelines for the application of ISO 9001:2008 to computer software	Ausgabedatum 2014 12 09	Art Standard	Zur Produktseite

load more

Recently Viewed

ÖVE/ÖNORM EN 62002-1

Mobile and portable DVB-T/H radio access - Part 1: Interface specification (IEC 62002-1:2008 + corrigendum 2008)

ÖNORM EN ISO 6370-2

Vitreous and porcelain enamels - Determination of the resistance to abrasion - Part 2: Loss in mass after sub-surface abrasion (ISO 6370-2:2020)

ÖNORM EN 2591-228

Aerospace series - Elements of electrical and optical connection - Test methods - Part 228: Ferrule withdrawal force