YY/T 1293.5-2017 (YY/T1293.5-2017, YYT 1293.5-2017, YYT1293.5-2017)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1293.5-2017 | English | 150 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Contacting wound dressing—Part 5: Alginate dressing
| Valid |
YY/T 1293.5-2017
|
Standards related to: YY/T 1293.5-2017
| Standard ID | YY/T 1293.5-2017 (YY/T1293.5-2017) | | Description (Translated English) | Contacting wound dressing. Part 5: Alginate dressing | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 10,156 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Quoted Standard | GB/T 6682; GB/T 16886.1; YY/T 0466.1; YY/T 0471.1-2004; YY/T 0615.1; ISO 11607-1-2006 | | Drafting Organization | Shandong Medical Device Quality Inspection Center | | Administrative Organization | State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | Notice of the State Food and Drug Administration of the People's Republic of China No. 49 of 2017; Announcement of the Industry Standards Proclamation No. 1 of 2018 (Total No. 217) | | Summary | This standard specifies the performance requirements and test methods for alginate dressings. This standard applies to aseptically supplied alginate dressings consisting only of alginate fibers. This standard does not include the requirements for alginate dressings containing antibacterial agents such as silver. | YY 1293.5-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 31
Contacting wound dressing - Part 5: Alginate dressing
ISSUED ON: MAY 2, 2017
IMPLEMENTED ON: APRIL 3, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Classification ... 6
4 Requirements ... 6
5 Biocompatibility ... 7
6 Test methods ... 7
7 Marks ... 10
8 Packaging ... 10
Annex A (informative) Infrared identification map of alginate ... 12
Contacting wound dressing - Part 5: Alginate dressing
1 Scope
This Part of YY 1293 specifies the performance requirements and test methods
for alginate dressing.
This Part is applicable to aseptically supplied alginate dressing that consists
only of alginate fibres.
This Part does not include requirements for alginate dressing containing silver
and other bacteriostatic agents.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 6682, Water for analytical laboratory use - Specification and test
methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Guidance
on selection of tests
YY/T 0466.1, Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
requirements
YY/T 0471.1-2004, Test methods for primary wound dressing - Part 1:
Aspects of absorbency
YY/T0615.1, Requirements for medical devices to be designated STERILE -
Part 1: Requirements for terminally sterilized medical devices
Pharmacopoeia of People's Republic of China (Edition 2010)
ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part
1: Materials, sterile barrier systems and packaging systems 1
1 The standard corresponding to ISO 11607-1 is GB 19633. The latest version has been submitted for approval.
Please pay attention to the publication.
6.2 Identification test
6.2.1 Extract fiber from alginate dressing for infrared identification based on
the reference to Annex A. The result shall be substantially the same as or in
between the two spectra of the alginate G infrared absorption spectrum or the
alginate M infrared absorption spectrum.
6.2.2 Weigh 5.0 mg of alginate dressing. Add 5mL of water, 1mL of freshly
prepared 1% of 1,3 dihydroxynaphthalene ethanol solution, 5mL of hydrochloric
acid, boil 3min and cool. Add 5mL of water. Extract with 15 mL of diisopropyl
ether. The dark purple in the upper layer shall be deeper than the blank made
in the same method.
6.2.3 Weigh 0.1g of alginate dressing. Add 5mL of water, boil, the sample shall
not dissolve. Add 2mL of 10% sodium carbonate solution to generate white
precipitate. Perform centrifugation and acidification to generate gelatinous
precipitate.
6.3 Loss on drying
Take 0.5g of alginate dressing. Conduct the test according to Annex VIII L in
Part II of Pharmacopoeia of People's Republic of China (Edition 2010).
6.4 pH test
Cut 1.0g of sample into about 1cm2 pieces. Put into a suitable container. Add
50mL of water. Seal at 37°C ± 1°C to soak 24h. Pour the liquid gently, mix, and
obtain the test solution. Determine the pH of the test solution and blank solution
with a pH meter. The difference of these two shall be inspection results.
6.5 Ignition residue test
Take 1.0g of alginate dressing. Conduct the test according to Annex VIII N
Ignition residue inspection method (500°C~600°C) in Part II of Pharmacopoeia
of People's Republic of China (Edition 2010).
6.6 Heavy metal test
Take residue left under 6.5. Perform according to Annex VIII H Heavy metal
inspection method in Part II of Pharmacopoeia of People's Republic of China
(Edition 2010).
NOTE Add 2mL of acetate buffer (pH3.5). After slight heat dissolution, if there is precipitation,
filtrate it and then move to Nessler colorimetric tube.
6.7 Iron content test
Take 1.0g of alginate dressing. Slow bake at 500°C~600°C till complete
carbonization. Let it cool. After adding 4 mL of hydrochloric acid to dissolve it,
transfer it to a 50 mL volumetric flask. Add water to the scale, shake, and
accurately measure 5mL. Perform according to Annex VIII G Iron salt inspection
method in Part II of Pharmacopoeia of People's Republic of China (Edition
2010).
6.8 Arsenic content test
Take 1.0g of alginate dressing. Add 1.0g of calcium hydroxide. Mix. Add water
to wet. First use a small fire to make the reaction complete. Then slowly bake
at 500°C~600°C to complete carbonization. Let it cool. Add 5mL of hydrochloric
acid and 23mL of water to make them dissolved. Perform according to Annex
VIII J Arsenic salt inspection method "Method One" in Part II of Pharmacopoeia
of People's Republic of China (Edition 2010).
6.9 Cadmium content test
Take 1.0g of alginate dressing. Slowly bake at 500°C~600°C to complete
carbonization. Let it cool. Add 5mL of hydrochloric acid and 23mL of water to
make them dissolved. According to Annex IV D Atomic absorption
spectrophotometry "Method One" in Part II of Pharmacopoeia of People's
Republic of China (Edition 2010), determine at 228.5nm.
6.10 Calcium content test
Take the sample under the weight loss test. Place in a crucible. Slowly cauterize
for about 20 min. Let it cool. Add a little hydrogen peroxide (0.5 mL to 1.0 mL).
Continue burning until there is no mass present. Fully gray at 700°C~800°C,
completely turning from dark red to white. Let it cool. Add 10mL of hydrochloric
acid (1+3), a few drops of concentrated nitric acid. Boil carefully. Transfer to a
100mL volumetric flask. Dilute with distilled water to the scale, shake. Use it as
test solution.
Accurately transfer 5mL of the above test solution into a 250mL Erlenmeyer
flask. Add 50mL of distilled water, 5mL of sodium hydroxide solution, 1mL of 10%
triethanolamine solution, 0.1g of calcium erythromycin indicator. Titrate with
EDTA standard solution (c=0.01 mol/L), when it turns from burgundy to bright
blue, it shall be the end. Calculate the calcium content according to equation
(1):
where,
c - EDTA titrant concentration in moles per liter (mol/L);
Calcium
content
...
|