產品信息

AYGüN器械滅菌盒設計和制造了多種不同型號和尺寸，以滿足無菌供應中心的多種應用要求。這些滅菌盒的設計是為了確保外科手術中使用的醫療器械、皮下醫療器械、手術工具和電手術工具的無菌狀態，并配有許多組件，如絲網籃、硅膠條、紡織品、過濾器和標簽。

Aygün器械滅菌盒設計用于醫療目的，通常用于臨床應用和醫療領域。該產品分為十大類，有許多不同之處。共有4種型號的過濾器，即紙質過濾器、紡織品過濾器、特氟龍過濾器和屏障過濾器，主要用于不同型號的容器。Aygün器械滅菌盒可用于運輸手術工具和無菌產品及其包裝、滅菌和滅菌后的無菌儲存。

Aygün器械滅菌盒可根據標準或客戶的需求制造不同尺寸的蓋子和盒子，配套不同操作技術的過濾器、過濾器支架、指示器和其他必要組件。按照無菌技術進行滅菌后，可以保證設備和工具在滅菌盒中6個月的無菌狀態。

HISTORY

AYGüN, one of the leading establishment of Turkey in the field of Medical Industry, was founded in 1988.

It manufactures Container Systems for sterilization, Surgical Motor Systems, Medical Illumination Systems and Single Use Medical Systems in its facility at Samsun Central Organized Industrial Zone.

AYGüN meets the needs of significant part of Turkey as a result of its continuous R&D works and the capacity increasing. It manufactures its products in international standards and put them to the world market with a high competitive power. Moreover with its integrated quality management system, it proves that it is a specialized establishment.

PRODUCT INFORMATION

Sterile Container systems manufactured by Aygün surgical instruments Inc. are designed and manufactured in a number of different types and sizes in order to meet the requirements of several applications available in sterile healthcare institutions.

These containers are designed in order to ensure the sterile condition of medical devices used in surgical operations, subcutaneous medical devices, surgical tools and electro-surgery tools and are equipped with a number of accessories such as wire basket, silicon strip, textile products, filters and labels.

Designed for medical purposes, Aygün Sterile Container Systems are commonly used in clinical applications and medical field in general. The product is manufactured under ten general groups with a large number of variations. A total number of 4 types of filters, namely, paper filter, cloth filters, teflon and barrier filter, were mainly used for containers with different models. Aygün Sterile Container System is manufactured for transportation of surgical tools and sterile products, their packaging, sterilization and sterile storage after sterilization Aygün Sterile Container System consists of different size lids and boxes manufactured in accordance with customer needs and standards, filter systems with different operating techniques, filter holders, indicators and other necessary accessories.

Following the sterilization process conducted in compliance with aseptic techniques, it is possible to store any devices and tools in the container for 6 months in a sterile manner.

質量管理體系

AYGüN 按照 ISO 9001、ISO 13485 標準和 CE 2007/42/EEC 指令進行生產，以其專家團隊和符合世界標準的產品滿足了外科醫生的需求，并且對患者的健康和安全給予了特別的重視。作為這些標準和指令的補充，它還獲得了FDA 510（K）批準。

在綜合管理體系政策的范圍內，它已采取有關質量、環境和職業健康、安全的所有必要預防措施，并采用目標確定的管理方法以針對這些要求進行認證。它根據法律義務確定其工作原則，并實現符合義務的所有生產條件。

CERTIFICATES

AYGüN, meeting needs or surgeons and giving particular importance to the health and safety of patients with its expert team and its products appropriate to the world standards, perform its production in accordance with ISO 9001, ISO 13485 standards and CE 2007/42/EEC directives. As an additional to these standards and directives, it also have FDA 510 (K)approval. Within the scope of Integrated Management System Policy, it has taken all needed precautions about Quality, Environment and Occupational Health and Safety with a management approach identified by objectives and certified for these requirements. It determined its working principle in consideration of legal obligations and fulfills all production conditions suitable to these obligations.