ISO 17665-2 PDF

May 7, 2020 0 Comments

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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The standard also requires detailed documentation of all conditions that affect the process performance now and in the future. Guidance on the application of ISO This document has been re-assessed by the committee, and judged to still be up to date.

The spores are incubated for 24 hours at the end of which time their growth rate is measured. Once removed, they must be allowed to 1766-52 to ambient temperatures, which may take several hours. LSO provides Contract Steam Sterilization services for any product capable of withstanding high-temperature sterilization.

ISO specifies requirements for the development, validation and routine 1765-2 of a moist heat sterilization process for medical devices. For effective sterilization it is critical that the steam covers all surfaces of the device. Although we endeavour to io 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.

We can 1766-2 any 177665-2 cycle parameters and duplicate an existing sterilization cycle or develop a cycle for specialized requirements. ISO only provides very general guidelines on steam sterilization requirements and operations. Moist heat sterilization processes covered by ISO For more information visit www. ISO covers sterilization of solid as well as liquid medical devices.


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.

ISO/TS 17665-2:2009

Steam sterilization process is not appropriate for many materials due to the high temperatures involved. The chemical tape is placed both inside and outside the sterilized packages, whereas bioindicator devices release spores inside the autoclave. Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing and generate a complete final report.

Customers review and approve the protocol before the validation process begins. Follow these links to find other Standards similar to the one you are viewing.

It is designed to cover every economic sector and virtually every activity of the humankind where technical standards may be used.

If the spores have been destroyed it indicates that the sterilization process was effective. Steam Sterilization is a simple yet very effective decontamination method. Like Us on Facebook. 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.

Our sterilizer features a high capacity 19 cubic foot chamber size. Biological indicator devices and Indicator tape which changes color are also used to gauge the performance of the autoclave. It is important to us that you purchase the right document.


We recommend that you check the website of the publishers of the international document before making a purchase. Saturated steam venting systems Saturated steam active air removal systems Air steam mixtures Water spray Water immersion.

Steam Sterilization for Medical Devices – ISO | Sterilization Validation Services

If you need help with the purchase or have any queries please email enquiries standards. International Classification for Standards ICS is an 17665–2 classification system for technical standards. Sterilized packages need to be allowed to dry before being removed from the autoclave to prevent contamination.

Product s are placed in a device called the autoclave and heated through pressurized steam to kill all microorganisms including spores. 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 ISO To ensure optimal conditions, many autoclaves have built in meters that display temperature and pressure conditions with respect to time.

The device’s exposure time to steam would be anywhere between 3 to 15 minutes, depending on the generated heat. ISO tries to describe these guidelines more 177665-2 through the use of examples and further explanation.