ISO 17665-2 PDF

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available. Find the most up-to-date version of ISO TS at Engineering the development, validation, and routine control of a sterilization process for medical devices. • ISO – Sterilization of health care products – Moist.

Author: Tokus Faujora
Country: Dominica
Language: English (Spanish)
Genre: Video
Published (Last): 7 July 2008
Pages: 235
PDF File Size: 19.44 Mb
ePub File Size: 14.45 Mb
ISBN: 293-1-73264-232-1
Downloads: 38412
Price: Free* [*Free Regsitration Required]
Uploader: Nerisar

ISO tries to describe these guidelines more specifically through the use of examples and further explanation.

Once removed, they must be allowed to cool to ambient temperatures, which may take several hours. LSO provides Contract Steam Sterilization services for any product capable of withstanding high-temperature sterilization.

Sterilized packages need to be allowed to dry before being removed from the autoclave to prevent contamination. Our sterilizer features a high capacity 19 cubic foot chamber size. ISO covers sterilization of solid as well as liquid medical devices.

GSO ISO/TS – Standards Store – GCC Standardization Organization

Although we endeavour to maintain an up-to-date catalogue, on occasion we may not have the latest version of a document, including where it has not yet been provided through an international feed. For effective sterilization it is critical that the steam covers all surfaces of the device. The guidance given in this Technical Specification is provided to promote uso practice related oso moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO Biological indicator devices and Indicator tape which changes color are also used to gauge the performance of the autoclave.


International Classification for Standards ICS is an international classification system for technical standards. Steam Sterilization is a simple yet very effective decontamination method. Product s are placed in a device called the autoclave and isoo through pressurized steam to kill all microorganisms including spores. Saturated steam venting systems Saturated steam active air removal systems Air steam mixtures Water spray Water immersion. It is designed to cover every economic sector and virtually every activity of the 176655-2 where technical standards may be used.

DD CEN ISO/TS 17665-2:2009

It is important to us that you purchase the right document. Follow these links to find other Standards similar to the one you are viewing. The spores are incubated for 24 hours at the end of which time their 1765-2 rate is measured.

To ensure optimal conditions, many autoclaves have built in meters that display temperature and pressure conditions with respect to time. Customers review and approve the protocol before the validation process begins. Steam sterilization process is not appropriate for many materials due to the high temperatures involved. The standard also requires detailed documentation of all conditions that affect the process performance now and in the future.

The chemical tape is placed both inside and outside the sterilized packages, whereas bioindicator devices release spores inside the autoclave.

ISO/TS 17665-2:2009

We recommend that you check the website 16765-2 the publishers of the international document before making a purchase. Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing and generate a complete final report.


ISO specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. The device’s exposure time to steam would be anywhere between 3 to isk minutes, depending on the generated heat.

If the spores have been destroyed it indicates that the sterilization process was effective. Moist heat sterilization processes covered by ISO We can program any desired cycle parameters and duplicate an existing sterilization cycle 1765-2 develop a cycle for specialized requirements. Office-based health care facilities – Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment You may be interested in this related standard Sterilization of health care products – Radiation – Guidance on dosimetric aspects You may be interested in this related standard.

Saturated steam venting systems Saturated steam active air removal systems Air steam mixtures Water spray Water immersion ISO covers sterilization of solid as well as liquid medical devices.

Steam Sterilization for Medical Devices – ISO | Sterilization Validation Services

Guidance on the application of ISO This document has been re-assessed by the committee, and judged to still be up to date. For more information visit www. If you need help with the purchase or have any queries please email enquiries standards. ISO only provides very general guidelines on steam sterilization requirements and operations. Isl Us on Facebook.