Disposable anesthesia puncture package production implementation details Wikipedia card "Disposable anesthesia puncture package production implementation details" on December 24, 2002 the State Drug Administration National Drug armed No. 2,002,472 issued since October 1, 2003 onwards implementation. The "rules" within the meaning of Disposable anesthesia puncture package products, including epidural nerve blocks, spinal anesthesia, nerve block anesthesia and other puncture,mercurial, injection drug Disposable anesthesia puncture package .


General prerequisite checking production principles and methods of assessment and inspection of the implementation appendix describes the rules by the State Drug Administration is responsible for interpretation Expand General Edit this section to regulate Disposable anesthesia puncture package production enterprises production behavior, for product quality control and quality management, according to "medical equipment manufacturing enterprises supervision and management measures", "Medical Device Registration", "medical device manufacturers quality system assessment methods", "sterile medical equipment production management practices "and" one-time use of sterile medical device supervision and management measures, "and refer to GB/T19001-2000" quality management system requirements "and YY/T0287-1996" Quality System - Medical Devices -GB/T19001-ISO 9001 Application requirements for "develop" one-time use of narcotic puncture kits production implementation details "(hereinafter referred to as" Rules "). The "rules" within the meaning of Disposable anesthesia puncture package products, including epidural nerve block (referred to epidural anesthesia), spinal anesthesia (referred to spinal anesthesia), and other nerve block anesthesia puncture, injection drug Disposable anesthesia puncture package (hereinafter referred to as "anesthesia kits," which includes configuring devices). The "rules" apply to the manufacturer of the product for medical device manufacturers license and medical device product registration card application, renewal, review, routine supervision and inspection assessment. The "rules" issued by the State Drug Administration, the State Drug Administration is responsible for issuing medical device product registration card, provincial and Drug Administration medical device manufacturers responsible for issuing licenses and implementation on evidence the daily supervision and management. Edit this paragraph prerequisite for a production, in accordance with GB/T19001-2000 standards and YY/T0287-1996 standard requirements for establishing, implementing and maintaining the interests of the "rules" the requirements of the quality management system, and effective operation. 2, at least the production Disposable anesthesia with a needle, anesthesia catheters, disposable sterile syringes and single-use sterile needles and other disposable sterile medical devices in one product. 3, the production of products Note (squeeze) plastic, sperm washing, drying (dry), inspection, assembly, packaging, etc. should be at the beginning of the same building of the plant body 100,000 for the clean area, clean area should be consistent YY0033-2000 "sterile medical equipment production management practices" requirements (see Appendix 7). 4, homemade or purchased products packaged in the early 300,000 for the clean area. 5, supporting the use of medical equipment purchased must be held medical device manufacturers license and product registration card company's products. 6, each of the product realization process should test or inspection procedures, inspection and equipped with qualified personnel and product specifications compatible with monitoring and measuring devices. Disposable anesthesia puncture package series reference testing equipment and facilities see Appendix 8,Adidas F50 FG, the relevant technical standards, see Appendix 9. Edit this paragraph inspection evaluation principles and methods of the "rules" for producers inspection evaluation range is divided into the quality management system documentation requirements; management responsibilities; resource management; customer-related processes; design and development; procurement; production process control; measurement, analysis and improvement, a total of eight projects, 30 terms, 160 checks, of which 12 entries, focus on examination of items 44, general check items 104. 2, the score set: total score of 895. Where: Record entry does not score; focus on checking items out of 10 points; generally check items out of 5 points. Accordance with the "check the contents" to determine the degree of compliance of the provisions to check items rated coefficient. Rating factor as follows: a. The required factor of 1; b. Essential to achieve the required factor of 0.8; c. Work has been carried out but flawed coefficient 0.5; d. Mainly the coefficient is 0. 3, the inspection team assessed when the entries focus on examination of the contents (see Appendix 6) should all pass, the remaining share of each project assessed the standard of the project more than 80% to pass. 4, the production enterprises to implement product sampling test, if negative results, the production enterprises should develop corrective measures within six months, the implementation of rectification, the rectification is complete re-implementation of the on-site inspection team product sample testing, such as testing is still unsatisfactory,mercurial vapor, then this checks can not be assessed. 5, in the production conditions during the inspection, found that the quality does not match with the actual record, at least deduct the full terms of the examination scores. 6, in the assessment process for manufacturing enterprises to find an objective examination of evidence, the inspection found that the terms do not meet the requirements should be prepared with the facts of record. 7, the inspection team found that the terms do not meet the requirements of manufacturing enterprises should be responsible to confirm. Manufacturers of the controversial issues raised by inspection teams, the inspection team should be accurately recorded, reported drug supervision and administration department. Edit this paragraph inspection appendix describes an implementation and organization inspection groups to group by the State Drug Administration and / or provincial drug supervision and management departments delegate. 2, check the way the implementation of on-site inspection team checking. 3, on-site inspection inspection inspection team of the enterprise, held its first meeting, on-site inspection found problems fill out the "Disposable anesthesia puncture package production conditions assessment for the case record form" (see Appendix 1), followed by exchange with business leaders opinions on the focus of inspection items, general inspection items unqualified person in charge of the enterprise to make a written confirmation. Final inspection group meetings held at the end to make on-site inspections to evaluate and fill out the "Disposable anesthesia puncture package production conditions assessment for conclusion Form" (see Appendix 2). 4, product sampling inspection team after the site inspection, the inspection team may be affected by the drug regulatory department commissioned, through on-site inspection of enterprises in accordance with "rules" corresponding attachment requirements for product sampling. Sampling, by the inspection team randomly selected samples from finished products and live like closure, fill out the "Disposable anesthesia puncture package product sampling single" (see Appendix 3), sampling methods, see Appendix 4. Sample should have been sealed sent within three days, by the designated medical equipment testing center. 5, exception handling when the inspection team at the inspection evaluation found that companies with fraud behavior, confirmed the circumstances are serious, the inspection team decided to terminate the right to inspect and report the results of drug supervision and management departments. 6, in order to ensure the inspectors accurate, impartial and effective work, inspectors should observe work discipline, corporate work for inspectors and opinions can fill out the "Disposable anesthesia puncture package inspectors on-site inspection Feedback Form" (see Appendix 5). This Article by the State Drug Administration is responsible for interpretation
創作者 huotop 的頭像


huotop 發表在 痞客邦 留言(0) 人氣()