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YY/T 1436-2016: Aids for ostomy and incontinence--Irrigation sets--Requirements and test methods
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1436-2016 | English | 179 |
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Aids for ostomy and incontinence--Irrigation sets--Requirements and test methods
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YY/T 1436-2016
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Basic data | Standard 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
Foreword
This 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 methods
1 Scope
This standard specifies the performance requirements and test methods for the lavage for colostomy care.
2 normative reference documents
The 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 management
3 terms and definitions
The 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.
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