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GB/T 40888-2021 English PDF

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US$194.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 40888-2021: Aids for ostomy and incontinence - Irrigation sets - Requirements and test methods
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 40888-2021	194	Add to Cart	3 days	Aids for ostomy and incontinence - Irrigation sets - Requirements and test methods	Valid

Similar standards

GB/T 42062 GB/T 16886.9 GB/T 42061 GB/T 40887.2 GB/T 40887.1

Basic data

Standard ID: GB/T 40888-2021 (GB/T40888-2021)
Description (Translated English): Aids for ostomy and incontinence - Irrigation sets - Requirements and test methods
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 11,112
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 40888-2021: 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 CCSC30 National Standards of People's Republic of China Stoma and incontinence assistive device irrigation device Requirements and test methods (ISO 16391.2002, IDT) Released on 2021-11-26 2021-11-26 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee

Foreword Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements 3 4.1 Accuracy of the capacity scale line 3 4.2 Leakage 3 4.3 Flow Controller 3 4.4 Suspension strength of irrigation water bag and suspension system 3 4.5 The suspension strength of the interface between the strap hook and the pressure plate 3 4.6 Biological Evaluation 3 5 General test conditions 4 5.1 Temperature 4 5.2 Reagent 4 5.3 Test sample 4 6 Test method 4 6.1 Accuracy of the capacity scale line 4 6.2 Leak 4 6.3 Flow Controller 5 6.4 Suspension strength of irrigation water bag and suspension system 5 6.5 Suspension strength of strap hook and pressure plate interface 5 6.6 Biological evaluation 6 7 Inspection report 6 Reference 7

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is equivalent to ISO 16391.2002 "Requirements and test methods for lavage devices for ostomy and incontinence aids". The Chinese documents that have consistent correspondence with the normatively cited international documents in this document are as follows. ---GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (ISO 10993-1.2009, IDT). This document has also made the following editorial changes. ---Added references. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed by the Ministry of Civil Affairs of the People's Republic of China. This document is under the jurisdiction of the National Standardization Technical Committee for Rehabilitation and Special Equipment for the Disabled (SAC/TC148). Drafting organization of this document. National Research Center for Rehabilitation Assistive Devices. The main drafters of this document. Ma Fengling, Li Mingjie, Yang Xue. Stoma and incontinence assistive device irrigation device Requirements and test methods

1 Scope

This document specifies the requirements and test methods for lavage devices for colostomy care.

2 Normative references

The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. ISO 10993-1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Risk Management Process (Biologicalevalua- tionofmedicaldevices-Part 1.Evaluationandtesting)

3 Terms and definitions

The following terms and definitions apply to this document. Some terms are illustrated in Figure 1. 3.1 Belt It is made of flexible material and is wrapped around the waist of the patient to fix the belt of the pressure plate of the drainage tube. 3.2 Colostomy A surgical incision or stoma made between the colon and the body surface. 3.3 Connector A device that connects the components of the lavage device. 3.4 Drainagesystem An assembly for lavage of various parts of the colostomy, including a drainage tube, a pressure plate, a stoma hole, a band hook and a band. 3.5 Drainagesleeve The catheter through which the lavage sewage passes from the colostomy to the waste disposal container. 3.6 Flowcontroler A device for adjusting the flow of irrigation water. Note. The flow controller is adjustable from the closed position to the fully open position. 3.7 Flow indicator A device that displays the flow of irrigation water. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 40888-2021_English be delivered?

Answer: Upon your order, we will start to translate GB/T 40888-2021_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 40888-2021_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 40888-2021_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+ countries

Question 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.