Name: UNI EN ISO 13408-5 : 2011
Brand: UNI

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE

Published date

15-09-2011

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Process and equipment characterization
6 Sterilizing agent characterization
7 SIP process
8 Validation
9 Routine monitoring and control
10 Personnel training
Annex A (informative) - Steam sterilization in place
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

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

Committee	CT 44
DevelopmentNote	Supersedes UNI EN 13824. (10/2011)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN 13824 : 2005

Standards	Relationship
ISO 13408-5:2006	Identical
EN ISO 13408-5:2011	Identical

ISO 13408-4:2005	Aseptic processing of health care products — Part 4: Clean-in-place technologies
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
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
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
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices