YY/T 1494-2016 English PDF

US$259.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1494-2016: Packaging materials for haemodialysis and related therapeutic concentrates--General requirements
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1494-2016	259	Add to Cart	3 days	Packaging materials for haemodialysis and related therapeutic concentrates--General requirements	Valid

Similar standards

YY/T 1680   YY/T 1571   YY/T 1561   YY/T 1493   YY/T 1492   

Basic data

Standard ID: YY/T 1494-2016 (YY/T1494-2016)
Description (Translated English): Packaging materials for haemodialysis and related therapeutic concentrates--General requirements
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Word Count Estimation: 13,184
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Quoted Standard: GB/T 1037; GB/T 1038; GB/T 5750.6-2006; GB/T 14233.1-2008; GB/T 14233.2-2005; YY 0598
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the general technical requirements for quality inspection of concentrate packaging materials for hemodialysis and related therapies, including classification and traits, requirements, test methods and marking, packaging, transportation and storage. This standard applies to hemodialysis and related treatment with concentrated packaging materials. This standard does not apply to the central supply of liquid and hospital preparation of the concentrated liquid packaging materials.

YY/T 1494-2016: Packaging materials for haemodialysis and related therapeutic concentrates--General requirements

---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.
Packaging materials for haemodialysis and related treatment concentrates - General requirements ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Hemodialysis and related treatment with thick General requirements for shrink packaging materials 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 Classification and traits 4 Requirements 1 5 Test method 4 6 mark, packing, transportation, storage 9 Reference 10

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. 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 is proposed by the State Food and Drug Administration. This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized. The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Guangzhou Kangsheng biotechnology has Limited company. The main drafters of this standard. He Yanying, Chen campus, He Xiaofan, Wan Yi Yi, Lv Pengju. Hemodialysis and related treatment with thick General requirements for shrink packaging materials

1 Scope

This standard specifies the general technical requirements for quality inspection of concentrate packaging materials for hemodialysis and related therapies, including classification and traits, Requirements, test methods and signs, packaging, transportation, storage. This standard applies to hemodialysis and related treatment with concentrated packaging materials. This standard does not apply to the central supply of liquid and hospital preparation of concentrated liquid packaging materials.

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. Plastics - Films and sheets - Permeability test method - Cup method Standard Test Method for Gas Permeability of Plastic Films and Flakes - Differential Pressure Method GB/T Standard Test Method for Drinking Water of Metals - Metals Indicators GB/T 5750.6-2006 GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods Concentration of hemodialysis and related therapies YY 0598 Pharmacopoeia of the People's Republic of China (2010 edition 2) Classification and traits 3.1 concentrate packaging materials are generally divided into concentrated packaging materials and dry powder packaging materials. 3.2 concentrated liquid packaging materials are generally high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyethylene terephthalate (PET) and so on. 3.3 Dry powder packaging materials are generally divided into low-density polyethylene (LDPE), polyethylene (PE), polypropylene (PP), PTP aluminum foil, Materials, nylon/PE composite film materials, SP composite membrane materials. 3.4 Direct contact with the concentrate packaging materials should be used above the food level (including food grade) raw materials production.

4 requirements

4.1 Concentrate packaging materials requirements 4.1.1 appearance Concentrated liquid packaging materials should be uniform and consistent color, no obvious color; the surface should be smooth, smooth, no deformation and obvious rub Marks; no trachoma, oil, bubbles; barrel mouth should be smooth, smooth. 4.1.2 Identification of infrared spectroscopy Infrared spectroscopy identification, should be consistent with the control map. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1494-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1494-2016_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 YY/T 1494-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1494-2016_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.