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GB/T 41170.1-2023 English PDF

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US$269.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 41170.1-2023: Skin barrier for ostomy aids - Test methods - Part 1: Size, surface pH and water-absorbency
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 41170.1-2023	269	Add to Cart	3 days	Skin barrier for ostomy aids - Test methods - Part 1: Size, surface pH and water-absorbency	Valid

Similar standards

YY/T 1680 GB/T 39381.1 YY/T 1571 GB/T 41171 GB/T 41172 GB/T 41170.2

Basic data

Standard ID: GB/T 41170.1-2023 (GB/T41170.1-2023)
Description (Translated English): Skin barrier for ostomy aids - Test methods - Part 1: Size, surface pH and water-absorbency
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.180.20
Word Count Estimation: 14,167
Date of Issue: 2023-08-06
Date of Implementation: 2024-03-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 41170.1-2023: Skin barrier for ostomy aids - Test methods - Part 1: Size, surface pH and water-absorbency

---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.
ICS 11.180.20 CCSC45 National Standards of People's Republic of China Test methods for skin protection products for stoma assistive devices Part 1.Size, surface pH and water absorption Size,surface pHHandwater-absorbency (ISO 12505-1.2014,MOD) Published on 2023-08-06 2024-03-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee

Preface III Introduction IV 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Skin protection product evaluation 2 4.1 Overview 2 4.2 Test conditions 2 4.3 Dimensional measurement 2 4.4 Surface pH value determination 6 4.5 Water absorption test 7 4.6 Inspection report 8 Reference 9 Figure 1 Dimensional measurement Figure 4 Figure 2 Measurement of stoma hole or pre-opening hole Figure 5 Figure 3 Thickness measurement Figure 6 Figure 4 Water absorption test 8 Table 1 Rounding method of test results 2

Foreword

This document complies with the regulations of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Custom drafting. This document is Part 1 of GB/T 41170 "Test Methods for Skin Protective Products for Ostomy Assistive Devices". GB/T 41170 has been The following sections have been published. ---Part 1.Size, surface pH and water absorption; ---Part 2.Moisture integrity and bonding strength. This document is modified to adopt ISO 12505-1.2014 "Test methods for skin protection products of stoma assistive devices - Part 1.Dimensions, Surface pH and water absorption. The technical differences between this document and ISO 12505-1.2014 and their reasons are as follows. ---Delete the normative reference document ISO 24214.2006, ISO 24214.2006 has been abolished; ---The normative reference document ISO 7886-1.1993 is replaced by ISO 7886-1.2017.ISO 7886-1.1993 has been abolished. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is 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 Disabled Persons (SAC/TC148). This document was drafted by. National Research Center for Rehabilitation Assistive Devices, Xiangya Hospital of Central South University, Kefu Medical Technology Co., Ltd., Xiamen Rui Deli Calibration and Testing Technology Co., Ltd., Pony Testing Group Co., Ltd. The main drafters of this document. Liu Junling, Ma Fengling, Liu Longfei, Liu Lixia, Li Mingjie, Ma Lifang, Fang Pengyue, Zhang Zhongwu, Sun Zhaozeng.

Introduction

Skin protection products seal and keep the ostomy bag on the skin, protect the skin around the stoma from stoma discharge, and allow the skin to pass through. Keep the skin's physiological functions intact by absorbing or penetrating sweat. Skin characteristics vary from person to person. The performance of skin protection products also depends on the type of stoma, purpose of use, environmental factors, nursing techniques, and users. vary from daily life to lifestyle. These complicate the testing situation. Based on laboratory and clinical testing, a variety of test methods have been developed Law. However, despite all the efforts and improvements, users still have problems with their skin, and trial and error is the main way to find the right product. method. Our main concern is the understanding of the product and the test methods used by users (purchasers, professionals, ostomy patients, etc.) sexual assessment capabilities. Skin protection products are an important part of ostomy products. It protects the skin around the stoma and holds the pouch in place. Skin protection products are elastic, corrosion-resistant, skin-friendly, and have adhesive properties. This adhesive property keeps the ostomy bag stationary during use. Can be removed later. Skin protection products come in many shapes, with different convexities and elasticities. Understand how skin protection products are designed and work formula will help provide the best product for ostomy patients. Skin protection products have different properties, so they need to be properly evaluated. Skin protection products can pass clinical trials or Laboratory test evaluation. This document only includes laboratory test methods, not clinical test methods. Actual values used in other national standards The laboratory test method was not developed for skin protection products but for industrial tapes. The test methods in this document include evaluation of size, surface pH and water absorption. This method is specially designed for the skin of stoma assistive devices. Skin protection product design. GB/T 41170 aims to specify the test methods for the relevant performance of skin protection products for stoma auxiliary devices and is planned to be released in two parts. ---Part 1.Size, surface pH and water absorption. The purpose is to describe the dimensions and appearance of skin protection products for stoma assistive devices. Test methods for surface pH and water absorption. ---Part 2.Moisture integrity and bonding strength. The purpose is to describe the moisture-resistant integrity of skin protection products for ostomy assistive devices. and adhesive strength test methods. Test methods for skin protection products for stoma assistive devices Part 1.Size, surface pH and water absorption

1 Scope

This document specifies test methods for skin protection chassis dimensions, surface pH and water absorption of ostomy assistive devices. This document does not include medical properties (cytotoxicity, sensitization, irritation/intradermal reactivity, buffering effect, microbial effects, etc.). The test methods in this document do not apply to specifying or recommending specific designs, styles or sizes of products, or to recommending treatments, care and other medical matters.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. testing-Specifications) Note. GB 15810-2019 Single-use sterile syringes (ISO 7886-1.2017, MOD) ISO 10523.2008 Water quality-DeterminationofpH (Waterquality-DeterminationofpH) Note. GB/T 22592-2008 General principles for determination of pH value of water treatment agents (ISO 10523.1994, NEQ)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Surface pH surface pH The value measured using a glass electrode pH meter under humid conditions on the part of the skin protection product that contacts the skin. 3.2 waterabsorbencywaterabsorbency The ability to allow water to penetrate skin protection products. 3.3 sample sample A small test piece representing an entire skin protection product, including a sample of a single representative part or a sample taken from the test piece as a test piece. 3.4 lineardimension lineardimension The shortest distance between any two selected points on the sample. ......

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Question 1: How long will the true-PDF of GB/T 41170.1-2023_English be delivered?

Answer: Upon your order, we will start to translate GB/T 41170.1-2023_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 41170.1-2023_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 41170.1-2023_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.