SS-EN-ISO-13408-5 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

SS-EN-ISO-13408-5 - 2011 EDITION - CURRENT


Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


1.1This part of ISO13408 specifies the general requirements for sterilization in place (SIP) applied to productcontact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processingand offers guidance on qualification, validation, operation and control.NOTESIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steamsterilization in place, which is the most common method used, is given in AnnexA.1.2This part of ISO13408 applies to processes where sterilizing agents are delivered to the internal surfacesof equipment that can come in contact with the product.1.3This part of ISO13408 does not apply to processes where equipment is dismantled and delivered to asterilizer.1.4This part of ISO13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regionaljurisdictions.1.5This part of ISO13408 does not specify requirements for development, validation and routine control of aprocess for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovinespongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced inparticular countries for the processing of materials potentially contaminated with these agents. NOTESee also ISO22442-1, ISO22442-2 and ISO22442-3.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.120.01 (Pharmaceutics in general)


Active implantable medical devices. Medical devices. In vitro diagnostic medical devices

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

ORDER

Price:

$128.58        




Designation Name

SS-EN ISO 13408-5:2011

Revision Level

2011 EDITION

Status

Current

Publication Date

July 12, 2011

Language(s)

English

Page Count

32

International Equivalent

EN ISO 13408-5:2011(IDT); ISO 13408-5:2006(IDT)