🇵🇱 SteriPack Medical Poland Sp. z o. o. PL
微生物环境水与废水
SteriPack Medical Poland Sp. z o. o. 是由 PCA 认可的实验室，认可编号 AB 1575（Jelcz-Laskowice，波兰）。认可范围涵盖 12 项检测方法，涉及以下领域：微生物、环境、水与废水。检测对象包括：医疗器械 E、环境样品 E － 空气、Biological indicators of the effectiveness of the sterilisation pro…、Environmental samples from production areas E - surface imprint。
要点速览
- 认可编号: PCA AB 1575
- 认可范围内方法数: 12
- 检测对象种类: 6
- 城市: Jelcz-Laskowice, 波兰
- 认可编号
- AB 1575
- 认可机构
- PCA
- 地址
- Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice
- 城市
- Jelcz-Laskowice, 波兰
该实验室检测什么 (6)
- 医疗器械 E — 3 项方法
- 环境样品 E － 空气 — 3 项方法
- Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E — 2 项方法
- Environmental samples from production areas E - surface imprint — 2 项方法
- Medical devices E Water E — 1 项方法
- Purified water E Highly purified water E Water for injections E Water for preparation of extracts E — 1 项方法
认可范围 — 项检测方法 (12)
| 序号 | 检测对象 | 方法 / 参数 | 技术 | 依据文件 | |
|---|---|---|---|---|---|
| 检测方法 | |||||
| 1 | 医疗器械 E | Sterility Culture method | PN-EN ISO 11737-2 Ph.Eur. | ||
| 2 | 医疗器械 E | Microorganism count Membrane filtration method Plate method (pour plate) | PN-EN ISO 11737-1 Ph.Eur. | ||
| 3 | Medical devices E Water E | Level of bacterial endotoxins Gel-clot technique Method A: Limit test Method B: Semi-quantitative test | Ph.Eur., 2.6.14; 5.1.10 USP <85> i <161> | ||
| 4 | 环境样品 E － 空气 | 用于微生物检验的采样 容积法 | LAB-16.12.00 | ||
| 5 | 环境样品 E － 空气 | 需氧微生物总数 平板法 | |||
| 6 | 环境样品 E － 空气 | Sampling for microbiological testing Gravimetric method | LAB-16.13.00 | ||
| 7 | Environmental samples from production areas E - surface imprint | Sampling for microbiological testing Contact plate method | PN-EN ISO 18593 | ||
| 8 | Environmental samples from production areas E - surface imprint | 需氧微生物总数 平板法 | LAB-16.10.00 | ||
| 9 | 医疗器械 E | Level of bacterial endotoxins Kinetic chromogenic technique Method D: quantitative test | Ph.Eur., 2.6.14; 5.1.10 USP <85> i <161> | ||
| 10 | Purified water E Highly purified water E Water for injections E Water for preparation of extracts E | Total count of aerobic microorganisms Membrane filtration method | Ph.Eur. | ||
| 11 | Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E | Presence of indicator microorganisms: Bacillus atrophaeus, Geobacillus stearothermophilus Culture method | LAB-16.09.00 | PN-EN ISO 11138-1 | PN-EN ISO 11138-7 | ||
| 12 | Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E | Count of indicator microorganisms: Bacillus atrophaeus, Geobacillus stearothermophilus Plate method (pour plate) | LAB-16.09.00 w oparciu o instrukcje producentów | ||
引用标准 (12)
LAB-16.09.00
LAB-16.09.00 w oparciu o instrukcje producentów
LAB-16.10.00
LAB-16.12.00
LAB-16.13.00
PN-EN ISO 11138-1
PN-EN ISO 11138-7
PN-EN ISO 11737-1 Ph.Eur.
PN-EN ISO 11737-2 Ph.Eur.
PN-EN ISO 18593
Ph.Eur.
Ph.Eur., 2.6.14; 5.1.10 USP <85> i <161>