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.

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If the spores have been destroyed it indicates that the sterilization process was effective. It is designed to cover every economic sector and virtually every activity of the humankind where technical standards may be used. 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. The device’s exposure time to steam would be anywhere between 3 to 15 minutes, depending on the generated heat.

Follow these links to find other Standards similar to the one you are viewing. Guidance on the application of ISO This document has isi re-assessed by the committee, and judged to still be up to date. The standard also requires detailed documentation of all conditions that affect the process performance now and in the future. Sterilized 1766-2 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.


GSO ISO/TS – Standards Store – GCC Standardization Organization

To isso optimal conditions, many autoclaves have built in meters that display temperature and pressure conditions with respect to time. Like Us on Facebook. Biological indicator devices and Indicator tape which changes color are also used to gauge the performance of the autoclave. We can program any desired cycle parameters and duplicate an existing sterilization cycle or develop a cycle for specialized requirements.

For effective sterilization it is critical that the steam covers all surfaces of the device.

Steam Sterilization for Medical Devices – ISO | Sterilization Validation Services

Moist heat sterilization processes covered by ISO ISO covers sterilization of solid as well as liquid medical devices. 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. 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.

Customers review and approve the protocol before the validation process begins. LSO provides Contract Steam Sterilization services for any product capable of withstanding high-temperature sterilization. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to Lso For more information visit www.


Steam sterilization process is not appropriate for many materials due to the high temperatures involved. Product s are placed in a device called the autoclave and heated through pressurized steam to kill all microorganisms including spores. ISO specifies requirements for the isk, validation and routine control of a moist heat sterilization process for medical devices.

ISO/TS 17665-2:2009

Saturated steam venting systems Saturated steam active air removal systems Air steam mixtures Water spray Water immersion. It is important to us that you purchase the right document. The spores are incubated kso 24 hours at the end of which time their growth rate is measured. International Classification for Standards ICS is an international classification system for technical standards. ISO tries to describe these guidelines more specifically through the use of examples and further explanation.

Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing and generate a complete final report.

Steam Sterilization is a simple yet very effective decontamination method. The chemical tape is placed both inside and outside the sterilized packages, whereas bioindicator devices release spores inside the autoclave. Once removed, they must be allowed to cool to ambient temperatures, which may take several hours.