Sterilization of Medical Devices | DIN ISO 17664:2004

Treatment Instructions for Reusable Medical Products

Instructions

BMT Medizintechnik GmbH

Treatment of reusable surgical instruments
All reusable surgical instruments delivered by BMT Medizintechnik GmbH that contain fixed parts (no flexible parts) and simple pin -joint constructs.
DIN ISO 17664:2004 - Sterilization of Medical Devices

Warnings

All instruments must be cleaned, disinfected and sterilized before each use; this is especially important before using for the first time
after delivery as all instruments are supplied non-sterile. Do not exceed 60 C (140F).
Special attention is required when cleaning instruments with pin-joints, springs, and tapped blind holes.
Restrictions of reprocessing: Limitation of reprocessing treatment: frequent reprocessing has little impact on these instruments. The end of life
time is normally defined by wear and tear due to usage.

Place of usage

Clean off any surface fouling with a disposable cloth/paper towel.

Storage and
Transport

No special requirements. It is recommended to carry out the reprocessing of an instrument directly after it is used particularly after it has been in
contact with foreign materials.

Cleaning
Preparation

No special requirements. Disassembling is not always necessary. It is however necessary to maintain hinged instruments in their open position
during cleaning/sterilization

Automatic
Cleaning

Equipment and Procedure: Cleaning /Disinfection device, detergent (standard).

1. Add pin-joint instruments into the automatic cleaner such that pin-joints are open, and water can drain out of the pi n -joints, springs, and tapped
blind holes (threaded holes).
2. Set cycle, wash not less than 5 minutes, and rinse 5 minutes.
3. When removing the instruments from the automatic cleaner review that the pin-joints, springs, and tapped blind holes are clear of any debris/dirt.
If necessary repeat cycle or clean manually.

Manual
Cleaning

Equipment and Procedure: detergent (standard), nylon brush, flowing water. :

1. Rinse off the instrument surface.
2. Apply detergent lotion with nylon brush onto all surfaces. Assure that pin-joint instruments are cleaned in both open and closed position. Note: When
cleaning pin-joints, springs, and tapped blind holes an adequate nylon brush should be used in order to reach all areas of the instrument.
3. The instrument is placed under flowing water for 1 minute. Ensure that water flows through the pin-joints, springs, and tapped blind holes.

Desinfection

Disinfection dissolution (standard) can be used in accordance with the instructions on label. During automatic cleaning, the rinsing cycle can be
done at 50C for 5 minutes towards the end to cause a thermal disinfection.

Drying

When drying is reached as part of the cleaning/disinfection cycle, 90C should not be exceeded.

Maintenance

It is recommended to put premium lubricant oil on the hinges of the instrument. Sort out any damaged instruments.

Control and
Functional Check

Verify that pin-joint instruments are free moving (avoid any large clearances). Locking mechanism functionality should be verified.
All instruments should be visually examined for any damage or wear and tear. Verify that the instrument is fully functional.

Preparation for
Sterilization

Compliant sterilization packaging as per ISO 11607 should be used.

It is necessary to ensure that the joints are opened and the water can flow out of tight clearances parts, joints, through and blind holes, as well as
joint and screws.
Packaging must be suitable for the instrument and shall protect it against microbiological contamination. The packaging seal must not be under
any tension.

Sterilization
(recommendation)

Prior to sterilization, products must undergo cleaning and disinfection, rinse out the residue using demineralized water and subsequently dry.
Compliant steam sterilization process (eg. Sterilizer in compliance with EN 285 and in accordance with DIN EN ISO 17665-1).
When using the steam sterilizer method, sterilization must be performed at 134C for a minimum period of 5 minutes followed by vacuum drying.

Storage

No special requirements. To maintain sterility keep instrument stored in the sealed sterilization pouch.

Additional Info

Do not exceed the maximum load of instruments in the sterilizer within any one cycle.

Manufacturer
Contact Information

BMT Medizintechnik GmbH

Moltkestrae 37-39, 78532, Tuttlingen, Germany | Tel 49-7461-966750 | Fax: 49-7461-966752 | E-mail: tut@BMTsurgical.com
Tuttlingen, Germany 2014.
Visit our website:

for instructions and methods of use.

bmt_form_certificate_DIN_ISO_17664_A4

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