SS-EN-ISO-14937 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 14937:2009)

SS-EN-ISO-14937 - 2009 EDITION - CURRENT
Show Complete Document History

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


1.1 Inclusions 1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products. 1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. 1.1.3 This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. 1.1.4 This International Standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process. NOTE It is not a requirement of this International Standard to have a full quality management system. The necessary elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.

To find similar documents by classification:

11.080 (Sterilization and disinfection)

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

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:

$176.58        




Designation Name

SS-EN ISO 14937:2009

Revision Level

2009 EDITION

Status

Current

Publication Date

Oct. 26, 2009

Language(s)

English

Page Count

56

International Equivalent

EN ISO 14937:2009(IDT); ISO 14937:2009(IDT)