YY 0033-2000 PDF EnglishUS$125.00 · In stock · Download in 9 seconds
YY 0033-2000: Good manufacture practice for sterile medical devices Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY 0033: Historical versions
Similar standardsYY 0033-2000: Good manufacture practice for sterile medical devices---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0033-2000YY 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 ContentsForeword... 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... 261 ScopeThis 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 standardsThe 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 JGJ 71-1990 Construction and acceptance specification of clean room3 DefinitionsThis Standard uses the definitions in GB/T 6583 and YY/T 0313 AND the following definitions. 3.1 Lot A certain quantity of a product that are with same property and quality manufactured under relatively stable condition. 3.2 Lot number A set of ��digits�� or ��letters and digits�� that are used to identify ��lot��. Base on that, it may trace and review the production history of this lot of products. 3.3 Production lot In a period, a certain quantity of a product that are with same property and quality, and continually manufactured under a same process. Note. To some continually manufactured products, sometimes it��s difficult to determine the production lot. For the needs of management, usually it may take the products manufactured in one working day or a shift as the production lot. 3.4 Sterilization lot In a same sterilized cabinet, a certain quantity of a product that are with same sterilization level and sterilized under same process. 3.5 Sterilization A validated process used to make products free of living microbiology in any shape or form. 3.6 Sterile There is no living microbiology on the medical device.4 Quality systemSterile 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. 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 4.3 Personnel 4.3.1 Enterprise shall assign management and technical staffs of all levels and types who have professional knowledge, production experience, and organizing ability compatible with sterile medical device production and be familiar with relevant national provisions for supervision and control of medical device, and who are responsible for organizing production and quality management. 4.3.4 Responsible person of departments of production management and quality management shall have professional knowledge and management experience relevant to his job; and have ability to make correct judgment and handling to practical problems during sterile medical device production and quality management.5 Production environment, facility and layout5.1 Location and factory Sterile medical device manufacturing enterprise must have clean production environment. The ground, road, and handling in factory shall not pollute the production of sterile medical device. 5.1.1 Location of factory shall be chosen at areas with good sanitary condition, fresh air, low concentration of dust and microbe in air, good natural environment and free from hazardous gas. 5.1.2 Location shall be far from the railway, port, airport, traffic artery, and factory, silo, stockyard that emit a lot of dust and hazardous gas and where have serious air pollution, water pollution, vibration or noise interference. Clean room shall not be less than 50m from municipal transport corridors. 5.2 Production facility According to the production process and product quality, production facility is divided into general production area and clean area. Facilities shall be reasonably designed according to production process flow and required air cleanliness classification. 5.2.1 General production area General production shall be reasonably designed with good light and ventilation to meet production requirements. 5.2.2 Clean area 5.2.2.1 Besides meeting the requirements of 5.2.1, clean area shall also be equipped 5.2.2.3 External window of personnel purification room and clean room (area) shall be double-window with good sealability. Ceiling of clean room (area) and the channel, wind gap and ceiling or wall of personnel purification room (area) shall be sealed. 5.2.2.4 Doors of clean room (area) shall be of effective sealed, and to be opened toward higher cleanliness direction. 5.2.2.5 Emergency door shall be set in clean room (area), and to be opened toward the escape exit, which shall be sealed well in normal time, and easy to open when emergency. The relief passage shall not be blocked. 5.2.2.6 Clean room (area) shall be reasonably designed according to process flow, and separate the direction of personnel flow and material flow. 5.2.2.7 Water and electricity lines in clean room (area) shall be placed under the wall surface. Mouth of the electricity and gas pipelines, junctions with wall and various electric appliances installed on wall shall be of effective sealed. 5.3 Personnel purification 5.3.1 Personnel purification rooms shall include room for changing footwear, room for keeping overall, rest room, room for wearing clean work clothes, room for air lock or room for air shower, etc. 5.3.2 Personnel shall be purified before entering into sterile medical device production clean room (area) or sterile operation clean room (area). Annex D provides the general procedure in and out of clean room (area). 5.3.3 At the room for changing footwear in personnel purification area, it shall pay attention to avoid cross contamination of two kinds of footwear. There shall have obvious boundary to limit the cross-over between the outside-footwear and the footwear to be changed. Slippers are forbidden in clean room (area). 5.4 Material purification 5.4.1 Clean measures shall be taken to material entering into clean production area, such as room for taking off external package and dust chamber. 5.4.2 It shall install air locks and double delivery windows between material purification room and clean room (area) to deliver materials and other goods. 5.4.3 External package used for material transportation and storage, and package material with caducous dust and fiber shall not be taken into clean room (area). Primary package material directly contacted with product shall be with at least two layers and with efficient anti-pollution during transportation, storage, and handling. 5.5 Process layout6 Facility and work clothes6.1 Design and shape of facility shall meet production requirements, with reasonable layout; and are easy to operate, repair, and maintain. 6.2 Facility and work clothes chosen in clean room (area) shall have measures of anti-dust, anti-pollution, and with simple structure, low noise, non-dust during working. Surface of facility, work clothes, and channel shall be smooth, even, non-shedding particles, easy to be cleaned and sterilized, and could reduce pollution. 6.3 Surface of facility, work clothes and channel directly contacted with material and product shall be innocuous, corrosion-resistant, non-blind angle, easy to be cleaned and sterilized, non-chemical reaction or accretion with material or product. 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.7 Purchasing and material management7.1 Enterprise shall have regulations to control purchasing process, establish purchasing documents such as purchasing plan, contract, and technical protocol. It clearly provides the quality requirements of purchased material to ensure the standard is met, and shall keep the copy of purchasing documents. 7.2 Enterprise shall evaluate suppliers, investigate and analyse their production environment (especially when purification is required), quality assurance, certificate, and reputation whether it meets national regulations. Before placing large order, enterprise shall trial out in a small amount, and then put into production after qualified inspection. It shall have relatively stable suppliers. It shall establish and keep suppliers�� quality record. 7.3 Purchased material shall be placed at area with obvious marking of ��waiting for inspection��, and it can only be released to warehouse after inspected qualified by quality inspection department. 7.6 Labeling, conformity certificate, operation instructions, and small package shall be specially kept. The distribution, usage, and destroy shall be recorded. 7.7 Special quarantine measures shall be taken to inflammable and explosive materials.8 Document8.1 Quality system document 8.1.1 Enterprise shall establish the quality manual describing their quality management document. 8.1.2 Enterprise shall establish procedure document, management document, and regulations required by this Standard, and effectively implement them. Note 1.GB/T 19001 and YY/T 0287 OR GB/T 19002 and YY/T 0288 stipulate the requirements of quality management system documents. 8.2 Technical document Enterprise shall have technical documents to guide the product manufacturing and usage of products, which shall be unified, complete, and correct. 8.3 Document control 8.3.1 Enterprise shall establish procedures of document control to control all documents (including quality manual, procedure documents, specifications, drawings, standards, process documents or work instructions, etc.) related to quality. Documents shall be approved before issuing. 8.3.2 Quality record document shall be established by written procedure and be controlled. It specifies the marks, storage, searching, protection, keeping time, and disposal of quality record.9 Quality management9.1 Enterprise shall have quality management department that is directly leaded by top management. The responsible person shall meet the requirements of 4.3.4. 9.2 Quality management department shall be staffed with a certain number of quality management and inspection personnel, and equipped with physical, chemical, and biological labs and inspection apparatus and instruments compatible with the production scale, type, and inspection requirements of sterile medical device. 9.3 Responsibility and authority of quality management department. 9.4 Quality management department shall perform receiving inspection and verification, process inspection, and product final inspection according to provisions; and issue inspection record and report. The record and/or report shall be signed by inspector and responsible person who releases the products. 9.5 According to provisions, quality management department shall conduct sampling, which shall be representative. 9.6 Quality management department shall evaluate suppliers together with other related departments. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY 0033-2000 be delivered?Answer: The full copy PDF of English version of YY 0033-2000 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY 0033-2000_English with my colleagues?Answer: Yes. 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