UNI EN ISO 13408-4 : 2011

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Current The latest, up-to-date edition.

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

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Published date: 14-09-2011

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

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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
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
Bibliography

Abstract - (Show below) - (Hide below)

Describes 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.

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Committee	CT 44
Development Note	Supersedes UNI EN 13824. (10/2011)
Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN 13824 : 2005

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 13408-4:2005	Identical
EN ISO 13408-4:2011	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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