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I.S. EN ISO 13408-4:2011

Current

Current

The latest, up-to-date edition.

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2011

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.

€37.00
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Process and equipment characterization
6 Cleaning agent characterization
7 CIP process
8 Validation
9 Routine monitoring and control
10 Personnel training
Annex A (informative) - Description of sampling methods
Annex B (informative) - Calculation examples for
        acceptance criteria
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 90/385/EEC on Active Implantable
         Medical Devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 98/79/EC on in vitro diagnostic
         medical devices

Provides the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

DevelopmentNote
Supersedes I.S. EN 13824. (07/2011)
DocumentType
Standard
Pages
31
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
ISO 13408-4:2005 Identical
EN ISO 13408-4:2011 Identical

ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software

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