当的中和物质 或在充足数量的培养基中稀释以中和其抗菌活性之后，进行该试验。当必须使用大量产品时，最好使用在配制时考虑了后续的稀释需要的浓缩培养基。在适当时，该 浓缩培养基可以直接加入到放在其容器中的产品。

OILY LIQUIDS 油性液体

Use media to which have been added a suitable emulsifying agent at a concentration shown to be appropriate in the validation of the test, for example polysorbate 80 at a concentration of 10 g per L.

使用已经加入了适当乳化剂的培养基，乳化剂浓度需已经证实适于该试验的验证，例如浓度为10克每升的聚山梨酯80。

OINTMENTS and CREAMS 油膏和乳膏

Prepare by diluting to about 1 in 10 by emulsifying with the chosen emulsifying agent in a suitable sterile diluent such as Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration). Transfer the diluted product to a medium not containing an emulsifying agent.

通过将选定的乳化剂在适当的无菌稀释液中乳化，例如液体A（见用于膜过滤的稀释和冲洗液），稀释至约1比10，来配制该产品。转移稀释后的产品至不含乳化剂的一个培养基中。

Incubate the inoculated media for not less than 14 days. Observe the cultures several times during the incubation period. Shake cultures containing oily products gently each day. However, when thioglycollate medium or other similar medium is used for the detection of anaerobic

microorganisms, keep shaking or mixing to a minimum in order to maintain anaerobic conditions. 将接种后的培养基培养不少于14天。在培养期中观察培养基若干次。每天轻轻摇动含有油性产品的培养基一次。但是，当使用巯基醋酸盐培养基或其他相似培养基检测厌氧微生物时，将摇动或混合保持到最少，以维持厌氧条件。

CATGUT and OTHER SURGICAL SUTURES FOR VETERINARIAN USE

兽医用肠线和其他外科缝合线

Use for each medium not less than the quantities of the product prescribed in Tables 2 and 3. Open the sealed package using aseptic precautions, and remove three sections of the strand for each culture medium. Carry out the test on three sections, each 30-cm long, which have been cut off

from the beginning, the center, and the end of the strand. Use whole strands from freshly opened cassette packs. Transfer each section of the strand to the selected medium. Use sufficient medium to cover adequately the material to be tested (20 mL to 150 mL).

在每个培养基中，使用不少于表2和3中 所规定数量的产品。采取无菌预防措施，打开封闭的包装，并取该股线的3个部分，分别至每个培养基。使用三节，每节30cm长，并分别从该股线的前端、中 间、末端截取的产品，进行该试验。使用从刚刚打开的包装盒中取出的整股线。将该股线的每个部分转移至选定的培养基。使用充足的培养基，以充分覆盖该供试物 料（20mL至150mL）

SOLIDS 固体

Transfer a quantity of the product in the form of a dry solid (or prepare a suspension of the product by adding sterile diluent to the immediate container), corresponding to not less than the quantity indicated in Tables 2 and 3. Transfer the material so obtained to 200 mL of Fluid Thioglycollate Medium, and mix. Similarly, transfer the same quantity to 200 mL of Soybean–Casein Digest Medium, and mix. Proceed as directed above.

转移干燥固体形态的产品（或通过加入无菌稀释剂至中间容器中配制该产品的悬浮液），数量不少于表2和3中的规定。转移如此获得的物料至200mL巯基醋酸盐液体培养基中，并混匀。同法转移同样数量的物料至200mL大豆－酪蛋白消化物培养基，并混匀。按照上述规定继续进行。

PURIFIED COTTON, GAUZE, SURGICAL DRESSINGS, and RELATED ARTICLES

脱脂棉花、纱布、外科敷料、相关物品

From each package of cotton, rolled gauze bandage, or large surgical dressings being tested, aseptically remove two or more portions of 100- to 500-mg each from the innermost part of the sample. From individually packaged, single-use materials, aseptically remove the entire article. Immerse the portions or article in each medium, and proceed as directed above.

对于待检的每个包装中的棉花、卷状纱布绷带、大块外科敷料，以无菌操作从该样品最核心的部位，取出2个或更多部分，每个部分100-500mg。从单个包装、一次性使用的物料中，以无菌操作取出整个物品。将这些部分或单个物品浸没在每个培养基中，并继续按照上述内容操作。

STERILE DEVICES 无菌设备

Articles can be immersed intact or disassembled. To ensure that device pathways are also in contact with the media, immerse the appropriate number of units per medium in a volume of medium sufficient to immerse the device completely, and proceed as directed above. For

extremely large devices, immerse those portions of the device that are to come into contact with the patient in a volume of medium sufficient to achieve complete immersion of those portions. 若干物品可以完整地或在拆开后浸没在培养基中。为确保设备通道与培养基接触，使用体积足够浸没整个设备的培养基，在每个 培养基中浸入适当数量的部件，并按照上述内容继续操作。对于极大的设备，将该设备中将要与患者接触的那些部分，浸入到体积足够完全浸没这些部分的培养基 中。

For catheters where the inside lumen and outside are required to be sterile, either cut them into pieces such that the medium is in contact with the entire lumen or fill the lumen with medium, and then immerse the intact unit.

对于内部的腔体和外部均要求无菌的导尿管，将它们切成片，这样培养基就可以接触整个腔体，或者用培养基填充腔体，然后浸没整个设备。

OBSERVATION AND INTERPRETATION OF RESULTS 结果的观测和理解 At intervals during the incubation period and at its conclusion, examine the media for macroscopic evidence of microbial growth. If the material being tested renders the medium turbid so that the presence or absence of microbial growth cannot be readily determined by visual examination, 14 days after the beginning of incubation transfer portions (each not less than 1 mL) of the medium to fresh vessels of the same medium, and then incubate the original and transfer vessels for not less than 4 days.

在培养期中间的观测点和作结论时，检查该培养基是否有肉眼可见的微生物生长的证据。如果供试物料导致培养基混浊，从而使得无法通过肉眼观察来确定是否存在微生物生长，在开始培养14天之后，将该培养基的若干部分（每个部分不少于1mL）转移至装有相同培养基的新鲜容器中，然后将原有和转移的容器培养不少于4天。

If no evidence of microbial growth is found, the product to be examined complies with the test for sterility. If evidence of microbial growth is found, the product to be examined does not comply with the test for sterility, unless it can be clearly demonstrated that the test was invalid for causes unrelated to the product to be examined. The test may be considered invalid only if one or more of the following conditions are fulfilled:

如果没有找到微生物生长的证据，则该供试产品符合无菌检查。如果找到了微生物生长的证据，则该供试产品不符合无菌检查，除非能够清楚地证实此次试验无效且无效原因与该供试产品无关。该试验仅可能在下面一个或多个条件被满足的情况下，才有可能认为无效： a. The data of the microbiological monitoring of the sterility testing facility show a fault.该无菌试验设施的微生物监控数据显示有缺陷。

b. A review of the testing procedure used during the test in question reveals a fault.对该试验过程中存有疑问的试验步骤进行审核后揭示出缺陷。

c. Microbial growth is found in the negative controls.在阴性对照中发现微生物生长。 d. After determination of the identity of the microorganisms isolated from the test, the growth of this species (or these species) may be ascribed unequivocally to faults with respect to the material and or the technique used in conducting the sterility test procedure.在从试验中分离出的微生物确定之后，此种（或这些种）微生物的生长可以毫不含糊地归咎于与物料和/或者进行无菌试验过程中所使用的方 法。

If the test is declared to be invalid, it is repeated with the same number of units as in the original test. If no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility. If microbial growth is found in the repeat test, the product examined does not comply with the test for sterility.

如果该试验证明无效，应用与原试验同样数量的产品进行复检。如果在复检中未发现微生物生长的证据，则该供试产品符合无菌试验的要求。如果在复检中发现了微生物生长，则该产品不符合无菌试验。

APPLICATION OF THE TEST TO PARENTERAL PREPARATIONS, OPHTHALMIC, AND OTHER NONINJECTABLE PREPARATIONS REQUIRED TO COMPLY WITH

THE TEST FOR STERILITY

此试验在注射药品、眼科和其他必须符合无菌试验的非注射药品中的应用

When using the technique of membrane filtration, use, whenever possible, the whole contents of the container, but not less than the quantities indicated in Tables 2 and 3, diluting where necessary to about 100 mL with a suitable sterile solution, such as Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration).

当使用膜过滤法时，只要可能，就要使用该容器的全部内容物，但不少于表2和3中规定的数量，必需时以适当的无菌溶液将其稀释至约100mL，例如液体A（见用于膜过滤的稀释和冲洗液）。

When using the technique of direct inoculation of media, use the quantities shown in Tables 2 and 3, unless otherwise justified and authorized. The tests for bacterial and fungal sterility are carried out on the same sample of the product to be examined. When the volume or the quantity in a single container is insufficient to carry out the tests, the contents of two or more containers are used to inoculate the different media.

当使用培养基直接接种法时，除非另有证据或授权，使用表2和3中显示的数量。用于检验细菌和霉菌的试验使用供试产品的同一个样品。当单一容器中的产品体积或数量不足以进行该试验时，适用2个或更多容器的内容物来接种不同的培养基。

1

In appropriate cases, periodic testing of the different batches prepared from the same lot of dehydrated medium is acceptable.

在适当的情况下，用同一个批次的脱水培养基配制的不同批次的定期试验是可以接受的