实验室检测标准

分类：医械法规
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发布时间：2021-12-15
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序号	标准号	标准名称
序号	标准号	标准名称
1	ISO/IEC 17025:2017	General requirements for the competence of testing and calibration laboratories
2	EN ISO 11737-1:2018	Sterilization of health care products - Microbiological methods - Part 1 : Determination of population of microorganisms on products
3	ISO 11737-1-2018	Sterilization of health care products - Microbiological methods - Part 1 : Determination of population of microorganisms on products
4	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
5	USP-NF2021 (61)	Microbiological examination of nonsterile products: microbial enumeration tests
6	《欧洲药典》 10.0版附录2.6.12	Microbiological examination of non-sterile products: microbial enumeration tests
7	第四部通则1105	2020版《中国药典》—非无菌检测产品微生物限度检查：微生物计数法
8	第四部通则1106	2020版《中国药典》控制菌检查法
9	USP-NF2021（62）	Microbiological examination of nonsterile products:Tests for specified microorganisms
10	《欧洲药典》 10.0版附录2.6.13	Microbiological examination of non-sterile products:Tests for specified micro-organisms
11	《欧洲药典》 10.0版附录2.6.1	Sterility
12	第四部通则1101	2020版《中国药典》—无菌检查法
13	USP-NF2021 (71)	Sterility tests
14	ISO 11737-2 2019	Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
15	EN ISO 11737.2-2020	Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
16	GBT 19973.2-2018	医疗器械的灭菌微生物学方法第2部分：用于灭菌过程的定义、确认和维护的无菌试验
17	GB/T 14233.2-2005	医用输液、输血、注射器具检验方法第2部分：生物学试验方法
18	第四部通则1143	2020版《中国药典》—细菌内毒素检查法
19	USP-NF2021(85)	Endotoxin Tests
20	《欧洲药典》 10.0版 2.6.14	Bacterial endotoxin
21	AAMI ST72-2019	Bacterial endotoxins —Test methods, routine monitoring, and alternatives to batch testing
22	YY/T0618-2017	医疗器械细菌内毒素试验方法常规监控与跳批检验
23	WS 310.3-2016	医院消毒供应中心第三部分：清洗消毒及灭菌效果检测标准
24	USP-NF2021(55)	Biological indicators - resistance performance tests
25	GB/T 19972-2018	医疗保健产品灭菌生物指示物选择、使用和结果判断指南
26	ISO 11138-7:2019	Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
27	GB 18281.1-2015	医疗保健产品灭菌生物指示物第1部分：通则
28	ISO 11138.1-2017	Sterilization of health care products - Biological indicators - Part 1: General
29	GB/T 16292-2010	医药工业洁净室(区)悬浮粒子的测试方法
30	GB/T 16293-2010	医药工业洁净室(区)浮游菌的测试方法
31	GB/T 16294-2010	医药工业洁净室(区)沉降菌的测试方法
32	GB/T 25915.3-2010	洁净室及相关受控环境第3部分:检测方法
33	GB/T 25915.1-2010	洁净室及相关受控环境第1部分：空气洁净度等级
34	GB/T 25915.1-2021	洁净室及相关受控环境第1部分：按粒子浓度划分空气洁净度等级
35	ISO 14698.1-2003	Cleanrooms and associated controlled environments – Bio contamination control - Part 1: General principles and methods
36	ISO 14644-1:2015	Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration
37	ISO 14644.3-2019	Cleanrooms and associated controlled environments - Part 3: Test methods
38	YY/T 0033-2000	无菌医疗器具生产管理规范
39	GB 50472-2008	电子工业洁净厂房设计规范(附条文说明)
40	YBB00412004-2015	药品包装材料生产厂房洁净室（区）的测试方法
41	GB 50073-2013	洁净厂房设计规范
42	GB 50591-2010	洁净室施工及验收规范
43	GB50687-2011	食品工业洁净用房建筑技术规范
44	YY/T1623-2018	可重复使用医疗器械灭菌过程有效性的试验方法
45	GB 15979-2002	一次性使用卫生用品卫生标准
46	GB 15981-1995	消毒与灭菌效果的评价方法与标准
47	YBB 00272004-2015	包装材料不溶性微粒测定法
48	GB/T 18204.2-2014	公共场所卫生检验方法第2部分：化学污染物
49	GB 19335-2003	一次性使用血路产品通用技术条件
50	GB 8369.1-2019	一次性使用输血器第1部分：重力输血式
51	GB 8368-2018	一次性使用输液器重力输液式
52	GB 16174.2-2015	手术植入物有源植入式医疗器械第2部分：心脏起搏器
53	ISO14708-2.2019	Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
54	T/CAMDI 009	《无菌医疗器械初包装》
55	USP-NF2021(788)	Particulate matter in injections
56	第四部通则0903	不溶性微粒检查法2020 版《中国药典》
57	YY 0286.1-2019	专用输液器第1部分：一次性使用微孔过滤输液器
58	YY /T1556-2017	医用输液、输血、注射器具微粒污染检验方法
59	YY/T1288-2015	一次性使用输血器具用尼龙血液过滤网附录 A
60	SN/T 1538.2-2016	培养基制备指南第2部分：培养基性能测试实用指南
61	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
62	GB/T 14233.1-2008	医用输液、输血、注射器具检验方法。第1部分：化学分析方法
63	ISO 10993-7-2008	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
64	EN ISO10993.7-2008	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
65	GB/T6682-2008	分析实验室用水规格和试验方法
66	/	2020《中国药典》第二部纯化水
67	/	2020《中国药典》第二部注射用水
68	/	2020《中国药典》第二部灭菌注射用水
69	/	2020《中国药典》第四部通则 0681制药用水电导率测定法
70	GB/T6672-2001	塑料薄膜与薄片厚度的测定机械测量法
71	YY/T0681.1-2018	无菌医疗器械包装试验方法第一部分：加速老化试验指南
72	ASTM F1980-2016	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
73	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
74	ASTM F88/F88M-2015	Standard Test Method for Seal Strength of Flexible Barrier Materials
75	YY/T 0698.1-2011	最终灭菌医疗器械包装材料第1部分:吸塑包装共挤塑料膜要求和试验方法
76	YY/T 0698.5-2009	最终灭菌医疗器械包装材料第5部分:透气材料与塑料膜组成的可密封组合袋和卷材要求和试验方法
77	EN 868.5-2018	Packaging for terminally sterilized medical devices Sealable pouches and reels of porous materials and plastic film construction-Requirements and test methods.
78	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
79	ASTM F1140/F1140M-2013（2020）	Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
80	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
81	YY/T 0681.4-2021	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
82	ASTM F1929-2015	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
83	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)
84	ASTM F2096-2011（2019）	Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
85	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
86	ASTM F2054/F2054M-2013（2020）	Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
87	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
88	ASTM F1886/F1886M-2016	Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
89	GB/T 19633.1-2015	最终灭菌医疗器械包装第1部分：材料、无菌屏障系统和包装系统的要求
90	GB/T 19633.2-2015	最终灭菌医疗器械包装第2部分：成形、密封和装配过程的确认的要求
91	ISO 11607-1:2019	Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
92	ISO 11607-2:2019	Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
93	GB/T 4857.1-2019	包装运输包装件基本试验第1部分：试验时各部位的标示方法
94	GB/T 4857.2-2005	包装运输包装件基本试验第2部分：温湿度调节处理
95	GB/T 4857.3-2008	包装运输包装件基本试验第3部分：静载荷堆码试验方法
96	ISO 2234:2000	包装.满装的运输包装和单元货物.静载荷法堆积试验
97	GBT 4857.4-2008	包装运输包装件基本试验第4部分采用压力试验机进行的抗压和堆码试验方法
98	ISO 12048:1994	Packaging -- Complete, filled transport packages -- Compression and stacking tests using a compression tester
99	ASTM D642-2020	Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads
100	GB/T 4857.5-1992	包装运输包装件跌落试验方法
101	ASTM D5276-2019	Standard Test Method for Drop Test of Loaded Containers by Free Fall
102	GBT 4857.7-2005	包装运输包装件基本试验第7部分正弦定频振动试验方法
103	ISO2247-2000	Packaging -- Complete, filled transport packages and unit loads -- Vibration tests at fixed low frequency
104	ASTM D999-2008(2015)	Standard Test Methods for Vibration Testing of Shipping Containers
105	GB/T 4857.10-2005	包装运输包装件基本试验第10部分：正弦变频振动试验方法
106	ISO 8318:2000	包装.满装的运输包装和单元货物.采用可变频的正弦振动试验
107	ASTM D3580-1995（2015）	产品振动实验的试验方法（垂直正弦曲线运动）
108	GB/T 4857.11-2005	包装运输包装件基本试验第11部分：水平冲击试验方法
109	GB/T 4857.13-2005	包装运输包装件基本试验第13部分:低气压试验方法
110	ISO 2244:2000	Packaging — Complete, filled transport packages and unit loads — Horizontal impact tests
111	ISO2873-2000	Packaging - Complete, filled transport packages and unit loads - Low pressure test
112	GB/T 4857.14-1999	包装运输包装件倾翻试验方法
113	ISO 8768:1987	Packaging — Complete, filled transport packages — Toppling test
114	ASTM D6179-2020	单元化货物和大型运输包装箱和板条箱粗暴装卸的试验方法
115	GB/T 4857.17-2017	包装运输包装件基本试验第17部分：编制性能试验大纲的通用规则
116	GB/T 4857.23-2012	包装运输包装件基本试验第23部分：随机振动试验方法
117	GB/T 4857.23-2021	包装运输包装件基本试验第23部分：垂直随机振动试验方法
118	ISO13355-2016	Packaging — Complete, filled transport packages and unit loads — Vertical random vibration test
119	ASTM D4728-2017	Standard Test Method for Random Vibration Testing of Shipping Containers
120	ASTM F2338-09(2020)	包装满装的运输包装和单元货物低压试验
121	YY/T 0681.15-2019	无菌医疗器械包装试验方法第15部分:运输容器和系统的性能试验
122	YY/T 0681.16-2019	无菌医疗器械包装试验方法第16部分:包装系统气候应变能力试验
123	ASTM D4169 - 2016	Standard Practice for Performance Testing of Shipping Containers and Systems
124	ISO 2248:1985	Packaging -- Complete, filled transport packages -- Vertical impact test by dropping
125	ASTM D4332-2014	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
126	ASTM D5487-2016	Standard Test Method for Simulated Drop of Loaded Containers by Shock Machines
127	ASTM D6653/D6653M-2013	Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
128	ASTM D6653/D6653M-2013（2021）	Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
129	GB/T 2918-2018	塑料试样状态调节和试验的标准环境
130	ASTM E171/E171M-2011 2020)	Standard Practice for Conditioning and Testing Flexible Barrier Packaging
131	ASTM D882-2018	Standard Test Method for Tensile Properties of Thin Plastic Sheeting.
132	ASTM F2825-2018	Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
133	ISTA 1A-2014	Non-Simulation Integrity Performance Tests Procedure 1A: Packaged-Products weighing 150 lb (68 kg) or less
134	ISTA 1B-2014	Non-Simulation Integrity Performance Tests Procedure 1B: Packaged-Products weighing Over 150 lb (68 kg)
135	ISTA 1C-2014	Non-Simulation Integrity Performance Tests Procedure 1C: Extended Testing for Individual Packaged-Products weighing 150 lb (68 kg) or less
136	ISTA 1D-2014	Extended Testing for Packaged-Products Over 150 lb (68 kg) or less
137	ISTA 1E-2014	Non-Simulation Integrity Performance Tests Procedure 1E: Unitized loads of same product
138	ISTA 1G-2014	Non-Simulation Integrity Performance Tests Procedure 1G: Packaged-Products weighing 150 lb (68 kg) or Less (Random Vibration)
139	ISTA 1H-2014	Non-Simulation Integrity Performance Tests Procedure 1H: Packaged-Products weighing Over 150 lb (68 kg) (Random Vibration)
140	ISTA 2A-2011	Partial Simulation Performance Test Procedure 2A: Packaged-Products 150lb (68kg) or less
141	ISTA 2B-2011	Partial Simulation Performance Test Procedure 2B: Packaged-Products Over 150lb (68kg)
142	ISTA 2C-2011	Partial Simulation Performance Test Procedure 2C: Furniture Packages
143	ISTA 3A-2018	Packaged-Products for Parcel Delivery System Shipments 70kg (150 lb) or Less
144	ISTA 3B-2017	Packaged-Products for Less-Than-Truckload (LTL) Shipment
145	ISTA 3E-2017	Similar Packaged-Products in Unitized Loads for Truckload Shipment
146	ISTA 3F-2017	Packaged Products for Distribution Center to Retail Outlet Shipment 100 lb (45 kg)
147	ISTA 3H-2011	Performance Test for Products or Packaged-Products in Mechanically Handled Bulk Transport Containers
148	ISTA 6- AMAZON.COM-Over Boxing-2018	e-Commerce Fulfillment for Parcel Delivery Shipment
149	ISTA 6-Amazon.com-SIOC-2018	Ships in Own Container (SIOC) for Amazon.com Distribution System Shipment
150	ISTA 6-FEDEX-A-2016	FedEx Procedures for Testing Packaged Products Weighing Up to 150 lbs
151	ISTA 6-FEDEX-B-2011	FedEx Procedures for Testing Packaged Products Weighing Over 150 lbs
152	ISTA 6-SAMSCLUB-2010	Packaged-Products for Sam’s Club® Distribution System Shipment (68kg)
153	GB 19489-2008	实验室生物安全通用要求
154	YY 0569-2011	Ⅱ级_生物安全柜
155	GB 2828.1-2012	计数抽样检验程序第1部分按接收质量限(AQL)检索的逐批检验抽样计划
156	AAMI-TIR12 -2020	Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers