GB/T 19971-2015 English PDFUS$294.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 19971-2015: Sterilization of health care products -- Vocabulary Status: Valid GB/T 19971: Historical versions
Basic dataStandard ID: GB/T 19971-2015 (GB/T19971-2015)Description (Translated English): Sterilization of health care products -- Vocabulary Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.99 Word Count Estimation: 15,132 Date of Issue: 2015-12-10 Date of Implementation: 2016-09-01 Older Standard (superseded by this standard): GB/T 19971-2005 Adopted Standard: ISO/TS 11139-2006, IDT Regulation (derived from): National Standard Announcement 2015 No.38 Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This standard specifies the terms in sterilization technology used in the field. This standard did not confirm the sterilization process and routine control of the request, but for understanding, use and development of standard sterilization techniques in the field to provide a basis for reference. GB/T 19971-2015: Sterilization of health care products -- Vocabulary---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Sterilization of health care products - Vocabulary ICS 11.080.99 C47 National Standards of People's Republic of China Replacing GB/T 19971-2005 Sterilization of health care products term (ISO /T S11139.2006, IDT) Issued on. 2015-12-10 2016-09-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces GB/T 19971-2005 "Sterilization of health care products the term" Compared with GB/T 19971-2005, the major change Of the following. --- Remove bioburden estimates contamination vector count before sterilization, the inner packaging products unit terms. --- Increased corrective measures to correct the design identification, dosimeter, dosimetry systems, packaging systems, preformed sterile barrier systems, pre Term preventive measures, protective packaging, sterile barrier systems. This standard uses the translation method identical with ISO /T S11139.2006 "Sterilization of health care products the term." Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized. This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shanghai Jinpeng source of radiation Technology Ltd., Guangzhou Improve Medical Technology Co., Ltd., Belimed Medical Equipment (Shanghai) Co., Ltd. The main drafters of this standard. Feng Dan Xi, Chen Qiang, Xu Gang, Xuwei Xiong, Huang new. This standard replaces the standards previously issued as follows. --- GB/T 19971-2005.IntroductionSterile medical devices is a non-viable microbial products. National standards for the confirmation of the sterilization process and routine control, When the medical equipment required in sterile form when it should be sterilized prior to its foreign microbial contamination is minimized. Even so, in character Combined quality system requirements (for example.. ISO 13485 2003) standard production conditions of production of medical equipment, or healthcare institutions After the medical device during the cleaning step reprocessing process before sterilization still with a small amount of micro-organisms, such products are non-sterile production Goods. Purpose of sterilization is to inactivate microbial contamination, so that the non-sterile products into sterile products. This standard is intended to cover the development or revision Sterilization of health care products related to aspects of the use of national standards. The standard's goal is to promote Described sterilization activities consistent and coordinated use of the term within the sterile field. Including the formulation and revision of a particular sterilization techniques, including national standards, we should first consider the definition of the standard. Of course, in order to break Combined needs of a particular application, it may be necessary to change some of the strict wording, such as increasing the explanatory notes. Even so, the use of the term is also Not conflict with this standard, and should be changed according to explain clearly to the user. This standard is a general standard, including a glossary of terms throughout the sterilization art, but does not replace each particular application identified the term. Sterilization of health care products term1 ScopeThis standard defines terms in sterilization technology used in the field. This standard did not confirm the sterilization process and routine control of the request, but for understanding, use and development of standard sterilization techniques in the field of Quasi provide the basis for reference.2 Terms and definitions2.1 Batch batch In determining the amount of production in the manufacturing cycle, expected or assumed to have the same characteristics and quality of certain products. 2.2 Bioburden bioburden Products and (or) sterile barrier system or inside the total number of viable microorganisms. 2.3 Biological indicators biologicalindicator Provisions sterilization process has a specific resistance, the test system containing viable microorganisms. 2.4 Calibration calibration Series of operations under specified conditions, is used to determine the indication of the measuring instrument or measuring system, or by a material measure or a reference material represented Values, and the relationship between the corresponding values \u200b\u200bobtained by the standard. [VIM.1993, definitions 6.11] 2.5 Change control changecontrol Products or procedures recommended by the appropriate change of assessments and decisions. 2.6 Chemical indicators chemicalindicator Non-biological indicators non-biologicalindicator Depending on the chemical or physical change in exposure to a sterilization process produced, showing a plurality of predetermined changes in process variables or tests system. 2.7 Cleaning cleaning Removal of contaminants on the article, so as to achieve the desired degree of further processing or intended use. 2.8 Corrective measures correctiveaction Measures to eliminate substandard or other undesirable situation discovered the reason taken. Note 1. a failure can have several causes. NOTE 2. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 19971-2015_English be delivered?Answer: Upon your order, we will start to translate GB/T 19971-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 19971-2015_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 19971-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version GB/T 19971-2015?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 19971-2015 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
