YY/T 0927-2014 PDF English
US$150.00 · In stock · Download in 9 secondsYY/T 0927-2014: Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0927-2014 | English | 150 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0927-2014
YY/T 0927-2014: Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0927-2014
GB
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.30
C 31
Guidance of determination for di (2-ethylhexyl)
phthalate (DEHP) released from PVC medical devices
Issued on. JUNE 17, 2014
Implemented on. JULY 1, 2015
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 6
2 Normative references... 6
3 General principles... 6
4 Principles for extract solution preparation... 6
5 Determination of DEHP release by gas chromatography / mass
spectrometer method (GC/MS)... 8
6 Determination of DEHP release by UV method... 12
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the content of this document may involve patents. The
issuing organization of this document does not undertake the esponsibility for
identification of these patents.
This standard was proposed by China Food and Drug Administration.
This standard shall be under the jurisdiction of National Technical Committee
on Medical Syringes of Standardization Administration of China (SAC/TC 106).
The drafting organization of this standard. Shandong Quality Inspection Center
for Medical Devices.
Main drafters of this standard. Sun Guangyu, Qin Dongli, and Li Wenjing.
1 Scope
This standard provides the chemical analysis methods for release of plasticizer
DEHP after medical device which takes PVC as raw material is contacting with
liquid of clinical use, under simulation of actual conditions of use.
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
3 General principles
3.1 Unless otherwise specified, room temperature in this standard shall be
10°C~30°C.
3.2 Test water in this standard shall meet requirements in GB/T 6682.
3.3 Unless otherwise specified, container used in this standard shall be
borosilicate glass container.
4 Principles for extract solution preparation
4.1 General principle
The preparation of DEHP extract solution in PVC medical devices shall consider
the clinical usage of those devices, then choose appropriate method for extract
solution preparation (e.g., extract solvent, time, temperature and mode of
action).
4.2 Preparation of extract solution of device in contact with blood or blood
components
4.3 Preparation of extract solution which takes sodium chloride injection
and/or glucose injection diluted lipid drugs as extract solvent
Clinically, sodium chloride injection and glucose injection are the most
commonly used drug infusion carriers.
4.4 Preparation of extract solution which takes other extract solvents
When devices are expected to contact with other mediums in clinical use
excepts the ones mentioned in 4.2 and 4.3, for example, nutrients or other body
fluids, it shall use the demonstrated and worst practical infusion liquid (or other
alternative liquids) which represents clinical use, as well as extraction manner
and conditions to conduct the extraction. Then take some extract solution as
test solution.
5 Determination of DEHP release by gas
chromatography / mass spectrometer method (GC/MS)
5.1 Principle
Use total ion chromatogram (TIC) scan mode of gas chromatography / mass
spectrometer method (GC/MS) to compare DEHP in sample solution, so as to
determine the nature, according to DEHP retention time, characteristic ion and
abundance of characteristic ion in DEHP standard solution.
5.2 Reagents
5.2.1 Ethanol. analytically pure.
5.3 Apparatus
5.3.1 Gas chromatograph-mass spectrometer (GC/MS).
5.3.2 Vacuum drying oven.
5.4 Working standard solution
5.4.1 Take about 20 mg of standard DEHP. Accurately weigh (to 0.1 mg). Use
hexane to dilute it to 10mL, and standard stock solution of which concentration
is about 2000 μg/mL shall be obtained (store it in the fridge at 2°C~10°C; 1
month validity).
5.5 Pre-treatment of sample extract solution
5.5.1 Pre-treatment of blood-contacting-device extract solution
5.5.2 Extract solution which takes sodium chloride injection and/or
glucose injection diluted lipid drugs as extract solvent
Take certain volume of extract solution prepared in 4.3 to dry in vacuum at 50°C.
After dying, cool it to room temperature. Then add hexane of equivalent volume.
Use vortex mixer to scroll and dissolve it for about 1 min. Take supernatant
liquid as inspection solution.
5.6 GC / MS conditions (recommendatory)
Chromatographic column. HP-5MS silica capillary column 30m × 0.25mm ×
0.25μm.
5.7 Determination and result analysis
5.7.1 Qualitative analysis
Determine DEHP standard solution, so as to confirm the retention time of DEHP
chromatographic peak under current conditions of temperament (unit is minute;
the example is shown in Figure 1), DEHP characteristic ions (including m/z=70,
83, 104, 112, 149, 167 and 279), and abundance of characteristic ion (the
example is shown in Figure 2). The retention time of chromatographic peak
detected in sample solution (the example is shown in Figure 3) is same with the
retention time of chromatographic peak of standard solution.
5.7.2 Quantitative analysis
Use external standard method. Quantitative selective ion of selective DEHP is
m/z=149.
6 Determination of DEHP release by UV method
6.2 Preparation of working standard solution
6.2.1 Use liquid specific gravity balance (or device of equivalent accuracy) to
prepare ethanol solution of which density is 0.8050 g/mL~0.8123 g/mL (at 20°C).
6.2.2 Take about 1 g of standard DEHP (make it accurate to 0.1 mg). Use
ethanol solution (density is 0.8050 g/mL~0.8123 g/mL) to dilute it to 100 mL.
And standard stock solution of which concentration is 10000 μg/mL shall be
obtained.
6.3 Determination and result calculation
6.3.1 At 272 nm, use extract solvent (refer to 4.2.1) as reference solution to
measure absorbance values of standard solution, and obtain working curve and
regression equation.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY/T 0927-2014 be delivered?Answer: The full copy PDF of English version of YY/T 0927-2014 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY/T 0927-2014_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0927-2014_English will be deemed to be sold to your employer/organization who actually paid 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+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0927-2014 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. How to buy and download a true PDF of English version of YY/T 0927-2014?A step-by-step guide to download PDF of YY/T 0927-2014_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 0927-2014".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|