Need help?

EN ISO 13408-7:2015 Standard

wave
Save  

  Keywords:

#process #aseptic #part #simulation #cannot

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

  Purpose

This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

  Publication

Friday 17th of November 2017

  Related Standards

EN 13795-1:2019

Medical devices Directive (93/42/EEC)

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 10993-1:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10651-6:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilat...

EN ISO 10651-4:2009

Medical devices Directive (93/42/EEC)

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

EN ISO 10651-2:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 13408-7:2015 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0