YY/T 1292.1-2015 English PDFUS$279.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1292.1-2015: Test for reproductive and developmental toxicity of medical devices - Part 1: Screening test Status: Valid
Basic dataStandard ID: YY/T 1292.1-2015 (YY/T1292.1-2015)Description (Translated English): Test for reproductive and developmental toxicity of medical devices - Part 1: Screening test Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 11.040.01 Word Count Estimation: 13,171 Date of Issue: 2015-03-02 Date of Implementation: 2016-01-01 Quoted Standard: GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.12 Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8 Issuing agency(ies): State Food and Drug Administration Summary: This Standard specifies the medical device or material reproductive and developmental toxicity screening test methods. This section applies to medical devices or materials reproductive and developmental toxicity test. YY/T 1292.1-2015: Test for reproductive and developmental toxicity of medical devices - Part 1: Screening test---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. Test for reproductive and developmental toxicity of medical devices Part 1. Screening test ICS 11.040.01 C30 People's Republic of China pharmaceutical industry standards Medical Devices reproductive and developmental toxicity test Part 1. Screening Test Part 1. Screeningtest Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released ForewordYY/T 1292 "Medical Devices reproductive and developmental toxicity test" intended to divide part of the publication, currently plans to release The following components. --- Part 1. Screening test; --- Part 2. embryo toxicity test; This section YY/T 1292 Part 1. This section drafted in accordance with GB/T 1.1-2009 given rules. Some elements of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part is proposed by the China Food and Drug Administration. This part of the National Biological evaluation of medical devices Standardization Technical Committee (SAC/TC248) centralized. This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, Shenzhen medical device testing Center, Beijing Union Medical College New Drug Safety Evaluation and Research Center Chinese Academy of Medical Sciences. The main drafters of this section. Hou Li, Regulation of. Cao Ping, Ye Xiangfeng.IntroductionDetect potential reproductive GB/T 16886.3 given and test methods for developmental toxicity substances are the Organization for Economic Cooperation and Development (OECD) method "chemical testing guidelines" set forth, but these methods are made for the development of chemical properties, but did not give details Test procedure, and therefore not suitable for the direct detection of medical devices or materials. The original part of the basic reference test method OECD421 Then, and according to the characteristics of medical devices or materials test methods were appropriate modifications, it provides detailed test procedure can be used as GB/T 16886.3 to one standard method of reproductive and developmental toxicity test. Reproductive medical devices or materials and developmental toxicity potential has a very important influence on human health. Especially for medical resorbable Devices containing leachables or medical devices. GB/T 16886.3 recommended the following medical devices or materials, in the absence of exclusion of reproductive and developmental toxicity Lower risk evidence, consider reproductive and developmental toxicity test. a) with possible reproductive tissue or embryo (fetus) direct long-term or permanent contact devices, resorbable or leachable material (such as silicon condensate Gel breast implants); b) storage of medical devices. This section used to design the evaluation of medical devices or material female and/or male reproductive function on the test, such as gonadal function, mating Behavior, pregnancy, fetal development and childbirth, the results of the information obtained is limited. Due to the limitations of the impact of the test sample preparation and test method validation, etc., in determining the reproductive and developmental toxicity test Previously, the need for full consideration of GB/T 16886.1 and GB/T 16886.18 requirements. Need as reproductive and made use of in the evaluation of medical devices Fertility risk of toxicity on the basis of the decision to be tested shall be demonstrated. Of resorbable or leachable medical devices containing filter material, if there is in the absorption, metabolism, distribution and research sufficiently reliable data, or Medical device materials were identified in extracts of all the ingredients or when no reproductive and developmental toxicity, no longer need to be tested. Medical devices After mechanical biological acceptable conduct risk assessment, risk such as reproductive and developmental toxicity has been ruled out, you do not need the test. Medical Devices reproductive and developmental toxicity test Part 1. Screening Test1 ScopeThis section YY/T 1292 specifies the medical device or material reproductive and developmental toxicity screening test methods. This section applies to medical devices or materials reproductive and developmental toxicity test.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials3 Terms and DefinitionsGB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 defined and the following terms and definitions apply to this document. 3.1 Reproductive toxicity reproductiontoxicity The performance of the parental male and female reproductive function or ability to damage and/or harmful effects on the progeny. 3.2 Maternal toxicity maternaltoxicity The performance of a specific (direct) or specific (indirect) adverse effects on female pregnant animals. 3.3 Damage impairmentoffertility Fertility The performance of male or female reproductive function or capability abnormal animal. 3.4 Developmental Toxicity developmentaltoxicity Reproductive toxicity performance means the offspring before birth, perinatal and after birth as demonstrated structural or functional abnormalities. 3.5 Dose dose The dose of the test substance. It expressed per unit of body weight of test animals administered an amount of the test substance (mg/kg), or incorporated into the feed or drinking water Constant concentration. 3.6 The amount of dosage Including dose, frequency of administration and collectively given period. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1292.1-2015_English be delivered?Answer: Upon your order, we will start to translate YY/T 1292.1-2015_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 YY/T 1292.1-2015_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1292.1-2015_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. 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