YY/T 1436-2016 English PDFUS$179.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1436-2016: Aids for ostomy and incontinence--Irrigation sets--Requirements and test methods Status: Valid
Basic dataStandard ID: YY/T 1436-2016 (YY/T1436-2016)Description (Translated English): Aids for ostomy and incontinence--Irrigation sets--Requirements and test methods Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.180.20 Word Count Estimation: 9,931 Date of Issue: 2016-01-26 Date of Implementation: 2017-01-01 Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25 Issuing agency(ies): State Food and Drug Administration YY/T 1436-2016: Aids for ostomy and incontinence--Irrigation sets--Requirements and test methods---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.Aids for ostomy and incontinence - Irrigation sets - Requirements and test methods ICS 11.180.20 C45 People's Republic of China Pharmaceutical Industry Standard Ostomy and incontinence aids Filling requirements and test methods (ISO 16391..2002, MOD) 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued ForewordThis standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to modify the use of ISO 16391..2002 "Ostomy and incontinence Aids Washers Requirements and tests method". The technical differences between this standard and ISO 16391..2002 are as follows. --- The requirements of Section 4.1 are the dimensions between any two tick marks in the volume indication (3.17) described in ISO 16391..2002 The difference should not deviate from the actual measured actual volume difference of ± 15% "modified to" volume indication (3.17) in any two scales The actual measured volume difference between the lines should not deviate from the ± 15% of the difference in volume between the two scale lines to facilitate the test Operation and result comparison. --- 6.3.4 The results of the unit by the ISO 16391..2002 in the "liter per minute" modified to "ml per minute", and the requirements of the requirements of 4.3 Units are consistent. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The main drafting unit of this standard. Shandong Province medical equipment product quality inspection center. This standard participates in the drafting unit. Leisure Music (China) Medical Supplies Co., Ltd., Shandong Hengxin Testing Technology Development Center. The main drafters of this standard. Zhang Qing, Gu Juan. Ostomy and incontinence aids Filling requirements and test methods1 ScopeThis standard specifies the performance requirements and test methods for the lavage for colostomy care.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management3 terms and definitionsThe following terms and definitions apply to this document. Some of these terms are shown in Fig. 3.1 Belt belt A soft band wrapped around the waist, connected to the platen of the discharge tube. 3.2 Colostomy colostomy Between the colon and the body surface through the surgical operation of the stoma. 3.3 Connector Devices that connect lavage equipment components. 3.4 Exhaust system The combination of components for colostomy discharge consists of a discharge tube, a pressure plate, a stoma hole, a hook and a belt. 3.5 Drained pipe drainagesleeve The fluid from the colon stoma is transferred to the sleeve of the waste collection container. 3.6 Flow regulator A device for regulating the flow of irrigation water. Note. The flow regulator can be adjusted between the closed position and the fully open position. 3.7 Flow indicator flowindicator A device for indicating the flow of irrigation water. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1436-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1436-2016_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 1436-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1436-2016_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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