產(chǎn)品簡介 Product Introduction

我公司生產(chǎn)的輔助生殖耗材系列產(chǎn)品從原材料的選擇到成品生產(chǎn)的各個環(huán)節(jié)，均經(jīng)過嚴格的質(zhì)量認證和安全檢測，為配子和胚胎提供更安全的培養(yǎng)條件和發(fā)育環(huán)境。根據(jù)不同操作流程的特點，精心設計、嚴格制造，保證胚胎和配子的安全。

Our human assisted reproductive laboratory (IVF) products are undergo strict quality certification and safety testing in all aspects from raw material selection to finished product, which provide more security culture condition and development environment for the gametes and embryos. According to the characteristics of different operation process,elaborate design, precision manufacturing, to ensure the safety of embryos and gametes.

特點 Characteristics

1. 通過歐盟ISO13485質(zhì)量管理認證體系，IVF產(chǎn)品CE標識；

Acquire the EU ISO13485 quality management system certification, and CE mark of IVF product.

2. 原材料采用美國藥典（USP）Class VI級測試聚苯乙烯及其他專用材料；

Raw materials are testing polystyrene and other special materials with United States Pharmacopoeia (USP) Class VI level ;

3. 嚴格控制生產(chǎn)工藝，制成品經(jīng)過生物相容性試驗（細胞毒性、皮膚刺激、皮膚致敏）、體外鼠胚實驗等檢測認證合格；

Strictly control the production process, finished products should pass biocompatibility tests (include cell toxicity, skin irritation, skin sensitization) and mouse embryo assay in vitro.

4. 產(chǎn)品經(jīng)過微生物限度檢查、滅菌劑量確認及滅菌劑量分布驗證，無菌保證水平SAL（輻射滅菌）達到10-6。產(chǎn)品經(jīng)檢驗無致熱源，細菌內(nèi)毒素不超過20EU/件；

The product was verified by microbial limit inspection, sterilization dose confirmation and confirmation of sterilization dose distribution,. The sterile assurance level SAL (radiation sterilization) have to reach 10-6. Inspect the product to make sure there is no heat source, and the bacterial endotoxin was no more than 20EU/ piece.

5. 產(chǎn)品包裝經(jīng)微生物屏障性能試驗檢測合格。

The product package should pass the microbial barrier performance test.