序号

No.

检测项目

Testing items

标准号

Standard No.

标准名称

Standard title

1

微生物计数

Microbial enumeration tests

2015版《中国药典》

2015 of Chinese Pharmacopoeia

第四部通则1105非无菌产品微生物限度检查：微生物计数法

Vol.Ⅳgeneral chapter1105 Microbiological examination of nonsterile products: microbial enumeration tests

美国药典 41

USP 41

美国药典 41 <61> 非无菌产品微生物限度检查：微生物计数法

USP 41  <61> Microbiological examination of nonsterile products: microbial enumeration tests

2

生物负载

Bioburden

ISO11737.1-2018

医疗保健产品的灭菌 微生物学方法 第1部分：产品上微生物数目的测定

Sterilization of health care products - Microbiological methods - Part 1: Determination of population of microorganisms on products

GB/T 19973.1-2015

医疗器械的灭菌 微生物学方法 第1部分：产品上微生物总数的测定

Sterilization of medical devices-Microbiological methods-Part 1:Estimation of population of microorganisms on products

3

无菌检查Sterility test

2015版《中国药典》

2015 of Chinese Pharmacopoeia

第四部通则1101无菌检查法

Vol.Ⅳgeneral chapter1101 Sterility test

美国药典 41

USP 41

美国药典 41  <71>  无菌检查法

USP41 USP41 <71>  Sterility test

GB/T 19973.2-2005

医疗器械的灭菌 微生物学方法 第2部分:确认灭菌过程的无菌试验

Sterilization of medical devices-Microbiological methods--Part 2:Tests of sterility performed in the validation of a sterilization process

ISO11737.2-2009

医疗器械的灭菌--微生物学方法--第2部分:定义、确认和保持灭菌过程的无菌试验

Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

4

环氧乙烷灭菌的生物监测

Biological monitoring of ethylene oxide sterilization

WS 310.3-2016

医院消毒供应中心 第3部分：清洗消毒及灭菌效果监测标准

Central sterile supply department (CSSD) - Part 3: Surveillance standard for cleaning, disinfection and sterilization

ISO14161-2009

医疗保健产品灭菌 生物指示物 选择、使用及检验结果判断指南

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

GB/T 19972-2005

医疗保健产品灭菌 生物指示物选择、使用及检验结果判断指南

Sterilization of health care products--Biological indicators--Guidance for the selection, use and interpretation of results

5

细菌内毒素检查

Bacterial endotoxin test

2015版《中国药典》

2015 of Chinese Pharmacopoeia

第四部通则1143 细菌内毒素检查法

Vol.Ⅳgeneral chapter 1143 Bacterial endotoxin test

美国药典 41

USP 41

 USP41 USP41 <85> 细菌内毒素检查

USP41 USP41 <85>  Bacterial endotoxin test

ANSI/AAMIST72:2011/(R)2016 8

细菌内毒素 - 测试方法、日常监控和批次选择

Bacterial endotoxin-Test methods, daily monitoring and batch selection  

GB/T14233.2-2005

医用输液、输血、注射器具检验方法第2部分：生物试验方法

Test method of medical infusion, blood transfusion and injection equipment - Part 2: Biological test method

6

生物指示物试验微生物数量的测定

Spore count of

biological indicators

美国药典41

USP41

生物指示物 —抗性测试

Biological indicators - resistance performance tests

 ISO 11138-1：2017 6, 7

医疗保健产品灭菌 生物指示物 第 1 部分：通则

Sterilization of health care products -Biological indicators -Part 1:Generarequirements

GB 18281.1-2015 6，7

医疗保健产品灭菌 生物指示物 第 1 部分：通则

Sterilization of health care products -Biological indicators -Part 1: General

7

环氧乙烷残留量

Determination of ethylene oxide residuals

GB/T 16886.7-2015

医疗器械生物学评价第7部分：环氧乙烷灭菌残留量

Biological evaluation of medical devices-Part 7:Ethylene oxide sterilization residuals

ISO10993.7-2008

医疗器械的生物学评价第7部分：环氧乙烷灭菌残留量

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

8

2-氯乙醇残留量

Determination of ethylene chlorohydrin residuals

GB/T 16886.7-2015

医疗器械生物学评价第7部分：环氧乙烷灭菌残留量

Biological evaluation of medical devices-Part 7:

Ethylene oxide sterilization residuals

ISO10993.7-2008

医疗器械的生物学评价第7部分：环氧乙烷灭菌残留量

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

9

薄膜厚度

Film thickness

GB/T6672-2001

塑料薄膜与薄片厚度的测定机械测量法

Plastics film and sheeting - Determination of thickness by mechanical scanning

10

目力检测包装密封完整性

Visually inspect package for seal integrity

YY/T 0681.11-2014

无菌医疗器械包装试验方法 第 11 部分目力检测医用包装密封完整性

Test methods for sterile medical device package - Part 11:Determining integrity of seals for medical packaging by visual inspection

ASTM F1886/F1886M-2016

目视检查测定医药包装密封件完整性的标准试验方法

Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

11

无约束包装抗内压破坏

 Internal Pressurization Failure Resistance of Unrestrained Packages

YY/T 0681.3-2010

无菌医疗器械包装试验方法 第 3 部分:无约束包装抗内压破坏

Test methods for sterile medical device package. Part 3:Internal pressurization failure resistance of unrestrained package

 ASTM F1140/F1140M-2013

无约束包装物抗内部加压损坏的试验方法

Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

12

内压法检测粗大泄漏（气泡法）

Deteting gross leaks in medical packaging by internal pressurization(bubble test)

YY/T 0681.5-2010

无菌医疗器械包装试验方法 第 5 部分:内压法检测粗大泄漏(气泡法)

Test methods for sterile medical device package-Part 5:Deteting gross leaks in medical packaging by internal pressurization(bubble test)

 ASTM F2096-2011

用内增压法检测医疗包装中总泄漏的试验方法(气泡法)

Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

13

软包装密封胀破试验

Burst testing of flexible package seals

 YY/T 0681.9-2011

无菌医疗器械包装试验方法 第 9 部分:约束板内部气压法软包装密封

胀破试验  

Test methods for sterile medical device package-Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates

 ASTM F2054/F2054M-2013

运用阻隔板内部气体加压法对软包装密封处进行破裂试验的试验方

法

Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

14

包装密封强度

Seal Strength of medical packaging

YY/T 0681.2-2010

无菌医疗器械包装试验方法 第2部分：软性屏障材料的密封强度

Test methods for sterile medical device package. Part 2:

Seal strength of flexible battier materials

ASTM F88/F88M-2015

挠性阻隔材料密封强度试验方法

Standard Test Method for Seal Strength of Flexible Barrier Materials

15

染色渗透

Dye penetration

YY/T 0681.4-2010

无菌医疗器械包装试验方法 第4部分：

染色液穿透法测定透气包装的密封泄漏

Test methods for sterile medical device package-Part 4:

Detecting seal leaks in porous packages by dye penetration

ASTM F1929-2015

用染料渗透试验法检测多孔渗水医用包装封层泄漏物的试验方法

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

16

加速老化

Accelerated

aging

YY/T 0681.1-2009

无菌医疗器械包装试验方法 第1部分：加速老化试验指南

Test methods for sterile medical device package-Part 1:

Test guide for accelerated aging

ASTM F1980-2016

医疗器械无菌屏障系统加速老化试验指南

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

17

温度

Temperature

ISO 14644.3-2005 B8

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

GB/T 25915.3-2010

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

18

相对湿度Relative humidity

ISO 14644.3-2005 B9

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

GB/T 25915.3-2010

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

19

静压差

Static pressure difference

ISO 14644.3-2005 B5

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

GB/T 25915.3-2010

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

20

换气次数

Air change rate

ISO 14644.3-2005 B4

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

GB/T 25915.3-2010

洁净室及相关受控环境 第3部分：检测方法

Cleanrooms and associated controlled environments - Part 3: Test methods

21

悬浮粒子

Airborne particles

ISO 14644.1-2015 附录 A

ISO 14644.1-2015 ANNEX A

洁净室及相关受控环境第 1 部分：空气洁净度等级

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness  

GB/T 25915.1-

2010 附录 B

GB/T 25915.1-2010 ANNEX B

洁净室及相关受控环境 第 1 部分：空气洁净度等级

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

GB/T 16292-2010

医药工业悬浮粒子测试方法

Test method for airborne particles in clean room(area) of the pharmaceutical industry

22

浮游菌

Airborne microbe

ISO 14698.1-2003 附录A

ISO 14698.1-2003 Annex A

洁净室及相关受控环境 生物污染控制 第 1 部分：般原则和方法

Cleanrooms and associated controlled environments -Biocontaminationcontrol - Part 1: General principles and methods

美国药典41(1116)

无菌处理环境的微生物控制和监测

USP41(1116)

Microbiological control and monitoring of aseptic processing environments

GB/T 16293-2010

医药工业洁净室（区）浮游菌的测试方法

Test method for airborne microbe in clean room(zone) of the pharmaceutical industry

23

沉降菌

Settling microbe

ISO 14698.1-2003 附录 A

 ISO 14698.1-2003 Annex A

洁净室及相关受控环境 生物污染控制 第 1 部分：一般原则和方法

Cleanrooms and associated controlled environments - Biocontaminationcontrol - Part 1: General principles and methods

美国药典41(1116)

无菌处理环境的微生物控制和监测

USP41(1116)

Microbiological control and monitoring of aseptic processing environments

GB/T 16294-2010

医药工业洁净室(区)沉降菌的测试方法

Test method for settling microbe in clean room(area) of the pharmaceutical industry

24

噪声

noise

GB 50073-2013 4.4

洁净厂房设计规范

Code for design of clean room

 GB 50591-2010 E.6

洁净室施工及验收规范

Code for construction and acceptance of cleanroom

25

照度

Illuminance

GB 50073-2013 9.2

洁净厂房设计规范

Code for design of clean room

 GB 50591-2010 E.7

洁净室施工及验收规范

Code for construction and acceptance of cleanroom GB 50591-2010 E.7