YY 0033-2000_English: PDF (YY0033-2000)
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Good manufacture practice for sterile medical devices
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YY 0033-2000
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Standards related to: YY 0033-2000
| Standard ID | YY 0033-2000 (YY0033-2000) | | Description (Translated English) | Good manufacture practice for sterile medical devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C30 | | Word Count Estimation | 13,180 | | Date of Issue | 2000-08-18 | | Date of Implementation | 2000-09-15 | | Older Standard (superseded by this standard) | YY/T 0033-1990 | | Quoted Standard | GB/T 6583-1994; GB/T 16292-1996; GB/T 16293-1996; GB/T 16294-1996; YY/T 0313-1998; JGJ 71-1990 | | Drafting Organization | State Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Technical Committee of Standardization for medical infusion | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the sterile medical instruments and parts production and quality management of the basic requirements. Sterile medical devices early production of packaging materials shall also comply with the requirements of this standard. | 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
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”;
j) ADD Annex D “General Procedure of Personnel In and Out of Clean Production
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
Drug Administration, China Quality Certification Center for Medical Devices, Tianjin
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
This Standard specifies the general requirements of production and quality
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
GB/T 16292-1996 Testing method of airborne particles in clean room (area) of
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
architectural structure, equipment, and affection have such functions of reducing the
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).
3.13 Material purification room
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.
Note 1. GB/T 19001 and YY/T 0287 OR GB/T 19002 and YY/T 0288 specify the requirements of
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).
6.6 It shall prepare enough working accessories with good sealing, easy to be
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
quality inspection, have obvious status marking and be detected and verified
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.
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