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YY 0033-2000

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YY 0033-2000 英文版 590 购买 现货,9秒内自动发货PDF,有增值税发票。 无菌医疗器具生产管理规范

   
标准编号: YY 0033-2000 (YY0033-2000)
中文名称: 无菌医疗器具生产管理规范
英文名称: Good manufacture practice for sterile medical devices
行业: 医药行业标准
中标分类: C30
字数估计: 13,120
发布日期: 2000-08-18
实施日期: 2000-09-15
旧标准 (被替代): YY/T 0033-1990
引用标准: GB/T 6583-1994; GB/T 16292-1996; GB/T 16293-1996; GB/T 16294-1996; YY/T 0313-1998; JGJ 71-1990
起草单位: 国家药品监督管理局济南医疗器械质量监督检验中心
归口单位: 全国医用输液器具标准化技术委员会
提出机构: 国家药品监督管理局
发布机构: 国家药品监督管理局


YY 0033-2000
YY
C 30
Record No. 0854-2001
Medical Industry Standard
of the People’s Republic of China
Replacing YY/T 0033-1990
Good manufacture practice for
sterile medical devices
无菌医疗器具生产管理规范
ISSUED ON. AUGUST 18, 2000
IMPLEMENTED ON. SEPTEMBER 15, 2009
Issued by. State Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Quoted standards ... 5 
3 Definitions ... 6 
4 Quality system ... 7 
5 Production environment, facility and layout ... 9 
6 Facility and work clothes ... 12 
7 Purchasing and material management ... 13 
8 Document ... 14 
9 Quality management ... 15 
10 Production process management ... 16 
11 Hygienic management ... 18 
12 Product sales and customer service ... 19 
Annex A ... 20 
Annex B ... 21 
Annex C ... 23 
Annex D ... 24 
Annex E ... 25 
Annex F ... 26 
Foreword
This Standard is the first revision of YY/T 0033-1990 “Good Manufacture Practice for
Sterile Medical Devices”.
The purpose of this revision is to carry out the “Regulations on the Supervision and
Management of Medical Devices”. At the same time, in order to strength the
supervision and management of medical devices, and to ensure the safety and
effectiveness of medical devices, the previous voluntary standard is converted into
compulsory standard.
Main differences between this Standard and YY/T 0033-1990 are as follows.
a) CHANGE “organization and personnel” TO “quality system”. It requires that the
enterprises, that manufacture the sterile medical devices, establish and
implement effective quality management system, and build complete
documents of quality management system.
b) CHANGE “production environment and layout” TO “production environment,
facility and layout”. ADD the requirements of water and wire line, working table,
compressed air, etc. in clean room (area); and ADD purification requirements
and process layout requirements to personnel and materials entering into clean
room (area);
c) “Facility and work clothes”. ADD the requirements of process water preparation
and storage and conveying equipment;
d) CHANGE “material and out-purchased pieces” TO “purchasing and material
management”. PROPOSE the evaluation to suppliers;
e) CHANGE “technical document” TO “document”. Beside the requirements to
technical documents, it also requires enterprises to establish “quality manual”
and “process document”. And PROPOSE the control requirements to
documents;
f) CHANGE “quality inspection and supervision” TO “quality management”;
g) “Production process management”. ADD “product labeling and traceability”,
“control of nonconforming product”, “corrective and preventive actions”, etc. And
SUPPLEMENT the content of package mark;
h) “Product distribution and customer service”. Enterprises shall establish the
adverse event report system, incident report system, and product recovery
system of sterile medical devices;
i) DIVIDE Annex B “environment requirements and application scope of control
area and clean area” INTO Annex B “Setting Principle of Cleanliness Class of
Production Environment for Sterile Medical Device” and Annex C “Environment
Requirements and Monitoring for Clean Room (area) of Sterile Medical Device”;
Area”, Annex E “verification and validation”, and other normative Annex.
Chapters 5, 6, 7, 11 of this Standard are compulsory, others are voluntary.
From the effective date, this Standard replaces YY/T0033-1990.
Annexes A, B, and C of this Standard are normative.
Annexes D, E and F of this Standard are informative.
This Standard was proposed by State Drug Administration.
Main drafting organization of this Standard. Jinan Medical Device Quality Supervision
and Testing Center of State Drug Administration.
Main participating organizations of this Standard. Medical Devices Division of State
Hanaco Medical Co., Ltd., and Shanghai Drug Testing Center of Food and Drug
Administration.
Main Drafters of this Standard. Wang Yanwei, Pu Changsheng, Shi Yanping, Chen
Zhigang, Cao Chenguang, Chen Yong, Wu Zhenmin, and Ji Wei.
Medical Industry Standard
of the People’s Republic of China
Good manufacture practice for sterile medical devices
Replacing YY/T 0033-1990
1 Scope 
management for sterile medical devices and the components and parts.
Production of primary package material of sterile medical devices shall also need to
meet the requirements of this Standard.
2 Quoted standards
The provisions in following standards become the provisions of this Standard through
reference in this Standard. The following standards are effective when issuing this
Standard. All standards would be revised, parties who use this Standard shall discuss
the possibility of using the newest version of the following standards.
GB/T 6583-1994 Quality management and quality assurance — Terms
medical industry
GB/T 16293-1996 Testing method of airborne microbe in clean room (area) of
medical industry
GB/T 16294-1996 Testing method of settling microbe in clean room (area) of
medical industry
YY/T 0313-1998 Package, labeling, transportation and storage of medical
polymer
3.9 Clean room (area)
The room (area) that is needed to control the particles and microbiology, whose
entry, generation and retention of pollution source in the room (area).
3.10 Cleanliness
The permitted statistical quantity of airborne particles that is equal to or larger than a
certain size in unit volume in clean environment.
3.11 Air purification
The action that removes the polluting substance to clean air.
3.12 Personnel purification room
The ancillary area that is used to purify personnel according to a certain procedure
before entering into clean room (area).
The ancillary area that is used to purify material according to a certain procedure
before entering into clean room (area).
3.14 Material
It refers to the raw material, supplementary material, package material, out-purchased
(processed) components and parts.
4 Quality system
Sterile medical device manufacturing enterprise shall establish and implement the
effective quality management system, build a complete document of quality
management system, and regularly conduct management review and internal review.
quality management system.
4.1 Quality policy
Quality policy shall be issued in document by the top management of the enterprise.
Quality objectives, understanding and implement of quality policy shall be established
at relevant functions and levels.
4.2 Organization
shall not pollute products.
6.5 Special mold room (area) shall be set to maintain and store the molds, and to
avoid pollution to clean room (area).
cleaned and sterilized. Working accessories in clean room (area) shall be strictly
separated with those in general production area, and be obviously marked, forbidden
cross using.
6.7 It shall have equipment of preparing process water. The ability of preparing water
of which shall meet production requirement. Process water shall be periodically
inspected according to standard. Storage and delivery channel of process water shall
be stainless steel or other innocuous material, and be cleaned, sterilized periodically.
6.8 Scope and accuracy of apparatus, instrument, gauge, weighing machine, etc.
used for production and inspection shall meet the requirements of production and
periodically.
6.9 Facility and work clothes shall be maintained, cared, and verified periodically.
When replacing equipment, it shall be verified to ensure no effect to product quality.
Refer t...
   
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