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Medical Device Manufacturing Vision

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41 views20 pages

Medical Device Manufacturing Vision

Uploaded by

nhatnguyentlm
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Our vision is to become one of the leading medical device manufacturers in the world by adopting
the understanding of “continuous improvement” and “quality is in detail” with sustainable growth in
the production of orthopaedic implants, orthopaedic surgical instrument sets, surgical instruments,
sterilization containers, perforated sheet baskets, orthopaedics instrument containers, arthoplasty
product and other medical devices.

Aysam Orthopaedics and Medical Devices Company has documented this vision with ISO 9001,
ISO 13485, and CE certificates.

Aysam serves over 80 countries around the world. We also serve as an OEM supplier to many
international companies.

Our main objective to achieve these goals is to bring innovation and quality together with trust.

Aysam, which has been producing sterile container systems for 20 years, also produces sheet
baskets and other accessories for containers and offers them to the service of the medical
community. With its young, dynamic, and expert staff, Aysam makes more innovative designs and
applications for different types of sterile containers and accessories.
In order to respond to the demands of the customers faster and with higher quality, Aysam educates
and informs its staff at an advanced level and aims to ensure the continuity of customer,
patient, and physician satisfaction under all conditions. Aysam increases both individual and
corporate quality with continuous and up-to-date training & information.

The results of scientific studies performed with Aysam Medical Devices are published in prestigious
journals. Aysam continues its development following the requirements of the age with its service
understanding that does not compromise on patient health, customer satisfaction, and quality,
and its open structure to innovations.

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Basic Model Bio-Barrier Model Mini Containers

Dental Containers Flat Containers Endoscopy Containers

Implant Containers Silicone Mat Paper Filter

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Basic Model - Half Size Containers

outside dimensions / mm outside dimensions / mm

285x280x100 285x280x135
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated

GRAY A310.10 A311.10 GRAY A310.13 A311.13

YELLOW A320.10 A321.10 YELLOW A320.13 A321.13

RED A330.10 A331.10 RED A330.13 A331.13

BLUE A340.10 A341.10 BLUE A340.13 A341.13

GREEN A350.10 A351.10 GREEN A350.13 A351.13

BLACK A360.10 A361.10 BLACK A360.13 A361.13

outside dimensions / mm outside dimensions / mm outside dimensions / mm

285x280x150 285x280x200 285x280x260


Bottom Bottom Bottom Bottom Bottom Bottom
COLOUR COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated Non-Perforated Perforated

GRAY A310.15 A311.15 GRAY A310.20 A311.20 GRAY A310.26 A311.26


YELLOW A320.15 A321.15 YELLOW A320.20 A321.20 YELLOW A320.26 A321.26
RED A330.15 A331.15 RED A330.20 A331.20 RED A330.26 A331.26
BLUE A340.15 A341.15 BLUE A340.20 A341.20 BLUE A340.26 A341.26
GREEN A350.15 A351.15 GREEN A350.20 A351.20 GREEN A350.26 A351.26
BLACK A360.15 A361.15 BLACK A360.20 A361.20 BLACK A360.26 A361.26

Basic Model - Special Size Containers

outside dimensions / mm outside dimensions / mm

350x250x100 350x250x135
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated

GRAY A910.10 A911.10 GRAY A910.13 A911.13

YELLOW A920.10 A921.10 YELLOW A920.13 A921.13

RED A930.10 A931.10 RED A930.13 A931.13

BLUE A940.10 A941.10 BLUE A940.13 A941.13

GREEN A950.10 A951.10 GREEN A950.13 A951.13

BLACK A960.10 A961.10 BLACK A960.13 A961.13

outside dimensions / mm

350x250x150
COLOUR Bottom Bottom
Non-Perforated Perforated

GRAY A910.15 A911.15

YELLOW A920.15 A921.15

RED A930.15 A931.15

BLUE A940.15 A941.15

GREEN A950.15 A951.15

BLACK A960.15 A961.15

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Basic Model - Middle Size Containers

outside dimensions / mm outside dimensions / mm


465x280x100 465x280x135
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated
GRAY A210.10 A211.10 GRAY A210.13 A211.13
YELLOW A220.10 A221.10 YELLOW A220.13 A221.13
RED A230.10 A231.10 RED A230.13 A231.13
BLUE A240.10 A241.10 BLUE A240.13 A241.13
GREEN A250.10 A251.10 GREEN A250.13 A251.13
BLACK A260.10 A261.10 BLACK A260.13 A261.13

outside dimensions / mm

465x280x150
Bottom Bottom
COLOUR
Non-Perforated Perforated

GRAY A210.15 A211.15


YELLOW A220.15 A221.15
RED A230.15 A231.15
BLUE A240.15 A241.15
GREEN A250.15 A251.15
BLACK A260.15 A261.15

Basic Model - Full Size Containers

outside dimensions / mm outside dimensions / mm

580x280x100 580x280x135
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated

GRAY A110.10 A111.10 GRAY A110.13 A111.13


YELLOW A120.10 A121.10 YELLOW A120.13 A121.13
RED A130.10 A131.10 RED A130.13 A131.13
BLUE A140.10 A141.10 BLUE A140.13 A141.13
GREEN A150.10 A151.10 GREEN A150.13 A151.13
BLACK A160.10 A161.10 BLACK A160.13 A161.13

outside dimensions / mm outside dimensions / mm outside dimensions / mm

580x280x150 580x280x200 580x280x260


Bottom Bottom Bottom Bottom Bottom Bottom
COLOUR COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated Non-Perforated Perforated

GRAY A110.15 A111.15 GRAY A110.20 A111.20 GRAY A110.26 A111.26

YELLOW A120.15 A121.15 YELLOW A120.20 A121.20 YELLOW A120.26 A121.26

RED A130.15 A131.15 RED A130.20 A131.20 RED A130.26 A131.26

BLUE A140.15 A141.15 BLUE A140.20 A141.20 BLUE A140.26 A141.26

GREEN A150.15 A151.15 GREEN A150.20 A151.20 GREEN A150.26 A151.26

BLACK A160.15 A161.15 BLACK A160.20 A161.20 BLACK A160.26 A161.26

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Bio-Barrier Model - Half Size Containers

outside dimensions / mm outside dimensions / mm outside dimensions / mm

285x280x100 285x280x135 285x280x150


Bottom Bottom Bottom
COLOUR COLOUR COLOUR
Non-Perforated Non-Perforated Non-Perforated

GRAY A310.10B GRAY A310.13B GRAY A310.15B


YELLOW A320.10B YELLOW A320.13B YELLOW A320.15B
RED A330.10B RED A330.13B RED A330.15B
BLUE A340.10B BLUE A340.13B BLUE A340.15B
GREEN A350.10B GREEN A350.13B GREEN A350.15B
BLACK A360.10B BLACK A360.13B BLACK A360.15B

outside dimensions / mm outside dimensions / mm

285x280x200 285x280x260
Bottom Bottom
COLOUR COLOUR
Non-Perforated Non-Perforated

GRAY A310.20B GRAY A310.26B


YELLOW A320.20B YELLOW A320.26B
RED A330.20B RED A330.26B
BLUE A340.20B BLUE A340.26B
GREEN A350.20B GREEN A350.26B
BLACK A360.20B BLACK A360.26B

Bio-Barrier Model - Middle Size Containers

outside dimensions / mm outside dimensions / mm

465x280x100 465x280x135
COLOUR Bottom Bottom
COLOUR
Non-Perforated Non-Perforated

GRAY A210.10B GRAY A210.13B


YELLOW A220.10B YELLOW A220.13B
RED A230.10B RED A230.13B
BLUE A240.10B BLUE A240.13B
GREEN A250.10B GREEN A250.13B
BLACK A260.10B BLACK A260.13B

outside dimensions / mm

465x280x150
COLOUR Bottom
Non-Perforated

GRAY A210.15B
YELLOW A220.15B
RED A230.15B
BLUE A240.15B
GREEN A250.15B
BLACK A260.15B

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Bio-Barrier Model - Full Size Containers

outside dimensions / mm outside dimensions / mm

580x280x100 580x280x135
COLOUR Bottom COLOUR Bottom
Non-Perforated Non-Perforated

GRAY A110.10B GRAY A110.13B


YELLOW A120.10B YELLOW A120.13B
RED A130.10B RED A130.13B
BLUE A140.10B BLUE A140.13B
GREEN A150.10B GREEN A150.13B
BLACK A160.10B BLACK A160.13B

outside dimensions / mm outside dimensions / mm outside dimensions / mm

580x280x150 580x280x200 580x280x260


Bottom Bottom Bottom
COLOUR COLOUR COLOUR
Non-Perforated Non-Perforated Non-Perforated

GRAY A110.15B GRAY A110.20B GRAY A110.26B

YELLOW A120.15B YELLOW A120.20B YELLOW A120.26B

RED A130.15B RED A130.20B RED A130.26B

BLUE A140.15B BLUE A140.20B BLUE A140.26B

GREEN A150.15B GREEN A150.20B GREEN A150.26B

BLACK A160.15B BLACK A160.20B BLACK A160.26B

Mini Containers

outside dimensions / mm
outside dimensions / mm
300x140x50 300x140x70
Bottom Bottom
COLOUR Bottom Bottom
Non-Perforated Perforated COLOUR
Non-Perforated Perforated
GRAY A410.04 A411.04 GRAY A410.07 A411.07
YELLOW A420.04 A421.04
YELLOW A420.07 A421.07
RED A430.04 A431.04
RED A430.07 A431.07
BLUE A440.04 A441.04
BLUE A440.07 A441.07
GREEN A450.04 A451.04
GREEN A450.07 A451.07
BLACK A460.04 A461.04
BLACK A460.07 A461.07

outside dimensions / mm

300x140x100
Bottom Bottom
COLOUR
Non-Perforated Perforated

GRAY A410.10 A411.10


YELLOW A420.10 A421.10
RED A430.10 A431.10
BLUE A440.10 A441.10
GREEN A450.10 A451.10
BLACK A460.10 A461.10

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Dental Containers

outside dimensions / mm outside dimensions / mm

310x190x50 310x190x65
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated

GRAY A510.04 A511.04 GRAY A510.06 A511.06

YELLOW A520.04 A521.04 YELLOW A520.06 A521.06

RED A530.04 A531.04 RED A530.06 A531.06

BLUE A540.04 A541.04 BLUE A540.06 A541.06

GREEN A550.04 A551.04 GREEN A550.06 A551.06

BLACK A560.04 A561.04 BLACK A560.06 A561.06

outside dimensions / mm outside dimensions / mm

310x190x100 310x190x130
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated

GRAY A510.10 A511.10 GRAY A510.13 A511.13

YELLOW A520.10 A521.10 YELLOW A520.13 A521.13

RED A530.10 A531.10 RED A530.13 A531.13

BLUE A540.10 A541.10 BLUE A540.13 A541.13

GREEN A550.10 A551.10 GREEN A550.13 A551.13

BLACK A560.10 A561.10 BLACK A560.13 A561.13

Flat Containers

outside dimensions / mm outside dimensions / mm

285x280x55 285x280x95
Bottom Bottom Bottom Bottom
COLOUR COLOUR
Non-Perforated Perforated Non-Perforated Perforated

GRAY A810.05 A811.05 GRAY A810.08 A811.08


YELLOW A820.05 A821.05 YELLOW A820.08 A821.08
RED A830.05 A831.05 RED A830.08 A831.08
BLUE A840.05 A841.05 BLUE A840.08 A841.08
GREEN A850.05 A851.05 GREEN A850.08 A851.08
BLACK A860.05 A861.05 BLACK A860.08 A861.08

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Endoscopy Containers

outside dimensions / mm outside dimensions / mm

250x60x50 450x70x70
Bottom Bottom
COLOUR COLOUR
Perforated Perforated
GRAY A711.05 GRAY A711.07
YELLOW A721.05 YELLOW A721.07
RED A731.05 RED A731.07
BLUE A741.05 BLUE A741.07
Bottom GREEN A751.05 GREEN A751.07
Perforated ( Non Filter )
BLACK A761.05 BLACK A761.07

Implant Containers

outside dimensions / mm outside dimensions / mm

310x138x65 500x155x75
COLOUR Bottom COLOUR Bottom
Perforated Perforated
GRAY A611.06 GRAY A611.07
YELLOW A621.06 YELLOW A621.07
RED A631.06 RED A631.07
BLUE A641.06 BLUE A641.07
GREEN A651.06 GREEN A651.07
BLACK A661.06 BLACK A661.07

Bottom
Perforated ( Non Filter )

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Teflon Filter Textile Filter

CAT.NO. PRODUCT NAME


CAT.NO. PRODUCT NAME
Single Textile Filter For Half, Special,
PTFE Filter For Half, Special, Middle A013.01
A014.01 Middle and Full Size Containers
and Full Size Containers
A013.02 Single Textile Filter For Mini Containers
A014.02 PTFE Filter For Mini Containers
A013.03 Single Textile Filter For Dental Containers
A014.03 PTFE Filter For Dental Containers

Paper Filter

CAT.NO. PRODUCT NAME

Paper Filter Pack Of 100 For Half, Special,


A012.01
Middle and Full Size Containers

Paper Filter Pack Of 100 For Mini & Dental Size Containers

CAT.NO. PRODUCT NAME

A012.02 Paper Filter Pack Of 100 For Mini Size


Containers
A012.03 Paper Filter Pack Of 100 For Dental
Containers

Plastic Security Seal

CAT.NO. PRODUCT NAME

A011.01 Pack Of 100 Plastic Security Seal

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Coloured Identification Label

Coloured
Identification Labes

COLOUR Bottom
Non-Perforated

GRAY A020.01
YELLOW A020.02
RED A020.03
BLUE A020.04
GREEN A020.05
BLACK A020.06

Paper Label With Indicator

CAT.NO. PRODUCT NAME

A010.01 Pack Of 100 Paper Label With Indicator


For Half-Midi-Full Size Containers

A010.02 Pack Of 100 Paper Label With Indicator


For Dental and Mini Containers

Sealing Gasket

CAT.NO. PRODUCT NAME

BA000.FU0-15 Basic full size box lid wick gasket


BA000.HA0-15 Basic half size box lid wick gasket
BA000.MI0-15 Basic middle size box lid wick gasket
BA000.SI0-15 Basic special size box lid wick gasket
BA0KR.0Fİ-03-02 Basic box chrome filter holder frame silicone gasket
BA0KR.0Fİ-03-03-05 Basic box chrome filter holder core silicone gasket
BA0PL.0Fİ-03-01 Basic box plastic filter holder body main part
BA0PL.0Fİ-03-02 Basic box plastic filter holder silicone sealing gasket
MD0KR.000-03-02 Mini dental box filter holder silicone gasket
MDK00.000-02-02 Mini dental box filter holder silicone sealing gasket
MDK00.DE0-05 Dental box case (cover box) sealing silicone gasket
MDK00.MI0-05 Mini box case (lid box) sealing silicone gasket

Silicone Mats

CAT. NO. PRODUCT NAME MM CAT. NO. PRODUCT NAME MM

A050.01 Silicone Mat 180x280 A050.05 Silicone Mat 380x230

A050.03 Silicone Mat 245x245 A050.06 Silicone Mat 440x230

A050.04 Silicone Mat 270x125 A050.07 Silicone Mat 520x230

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AYSAM STERILE CONTAINER COMPONENTS

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- Aysam Sterilization Container Systems are reusable and anodized containers used to sterilize im-
plants, surgical instruments and textiles, and keep and carry them as sterile.

- Aysam Sterilization Container Systems are designed for daily use and years of use.

- Therefore, when choosing sterilization


container systems, make sure that the container and instruments comply with the application and
sterilization requirements.

- Aysam Sterilization Containers are made of EN AW 1050 quality aluminum and AISI 304 stainless
steel (EN 1.4301) following territorial and international standards.

- Due to the large number of aluminum parts in the design, handling and transporting are easier.

- Anodization has been applied to the lids, bottom, and other aluminum components of the Sterile
Containers to increase its resistance against external factors and to gain a decorative appearance.

- Aysam Sterile Container Systems are packaged and shipped as non-sterile.

- Aysam Sterile Containers are suitable for steam and ethylene oxide sterilization.

Removing and attaching the filter holder and changing the filter.

1. LID
-Aysam Sterilization Container Systems, there are holes for air
passage on the outer surface of the lid.

- There is a silicone gasket on the inner surface of the lid,


providing air and waterproof along the edge.

- In the middle of the lid, there is a lockable filter retainer, that


holds the filters tightly and has a sealing gasket on the top
(center and peripheral parts), made of stainless steel or plastic.

- There are spring latches on both sides of the lid that provide
locking by springing into the bottom.

- The silicones in the lid, filter retainer, and handles are made of
materials resistant to hot application in the autoclave.

- Sterilization container lids are produced in six different colors


like gray, black, green, red, yellow, and blue. These color dif-
ferences provide convenience for you in storage

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2. BOTTOM
- On both sides of sterilization container bottoms, there
are label attachment co mpartments, handles, and
lock parts through which plastic disposable security seal
passes.

- Paper labels with indicators are placed in the label


attachment compartments of container bottoms for
sterilization process and follow-up details.

- In mini, dental, and flat sterilization containers, there


are aluminum label placement pieces on the side of
the lid, suitable for paper label indicator.

3. ACCESSORIES
- The disposable consumables of the Container
Systems are paper, textile, and Teflon filters, plastic
security seals, and sterilization indicator labels.

- Paper, textile, and Teflon filters provide effective


protection by preventing microorganisms from
entering the container after sterilization.

- Paper filters are disposable and should be changed


at every sterilization process. Textile filters for 20 uses;
Teflon filters are for 2000 uses.

- For the stacking of small, mini, and micro-instruments in the container, it is recommended to use a
silicone mat on the floor.

- Sheet/wire baskets of Aysam containers can be cleaned


and sterilized following the accepted instructions and
using the same procedures as Aysam Sterilization Container
bottoms.

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BIOBARRIER STERILE CONTAINER
In addition to the features of Basic (Filtered) Sterile Container, in Aysam Biobarrier Containers;

- There are one or two mechanical biobarrier valves with silicone seals on the lid.

- Biobarrier valves operate by opening/closing with the air pressure generated in the autoclave
during sterilization.

Thanks to the biobarrier system and the silicon gaskets used in it, the air is removed from the
container during sterilization, the pressurized hot water steam enters the container through the
biobarrier valves, and finally the hot steam is discharged out by the impact of vacuum.

- Biobarrier Sterilization Container Systems are mechanical systems consisting of valves and silicon seals. Dur-
ing the sterilization;

1- In the first stage, the upper valve opens with the effect of negative (-) pressure in the
(pre-vacuum) autoclave and thus the air is removed from the container and autoclave
(Figure 2).

2- Then, the small valve is opened by pushing down with the effect of positive (+) pressurized hot water vapor
(2-3 atm; 134°C) given to the autoclave and hot steam air enters the container (Figure 3).

3- In the last stage, the upper valve of the container is opened again with the effect of negative (-) pressure in
the autoclave and the hot steamed air inside is removed from the container and
autoclave (Figure 4).

- Besides, since the biobarrier system is closed after sterilization and prevents air entry and exit, container
maintains the sterility until it is opened during the surgical procedure.

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Aysam, which has been exporting to five continents of the world for twenty years, has been increasing the
number of distributors and dealers day by day and advancing confidently towards its goals. Besides, Aysam
continues its activities with companies of distributor and dealer in full harmony and loyalty. Aysam partici-
pates in national/international fairs and congresses and offers its product groups to the service of the Medical
World. By regularly participating in the world’s largest and most prestigious fairs such as Medica/Düsseldorf,
Arab Health/Dubai, Expomed/Istanbul as well as other congresses and organizations, it continuously increas-
es its interaction with customers and end-user healthcare professionals. Aysam has adopted the principle
of quality, advanced, and innovative production by customer feedback, R&D studies, specialist physicians,
dynamic&experienced engineers, and modern infrastructure in accordance with the requirements of the
age.

Aysam manufactures medical devices in seven groups: ORTHOPAEDIC implants, arthroplasty products, surgi-
cal sets, surgical instruments, perforated sheet baskets, orthopaedic instrument containers and sterilization
containers. With new R&D studies, it continues to add new products to its nearly 20 thousand product range.
Combining 20 years of knowledge with modern technology, Aysam produces its devices in a more innovative
and quality way.

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