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YY 0332-2011 English PDF

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YY 0332-2011: Implantable drug-supplying device
Status: Obsolete

YY 0332: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0332-2011English519 Add to Cart 3 days [Need to translate] Implantable drug-supplying device Obsolete YY 0332-2011
YY 0332-2002English359 Add to Cart 3 days [Need to translate] Implantable drug-supplying device Obsolete YY 0332-2002

PDF similar to YY 0332-2011


Standard similar to YY 0332-2011

YY/T 0334   YY/T 0326   YY/T 0328   YY 0329   YY/T 0325   

Basic data

Standard ID YY 0332-2011 (YY0332-2011)
Description (Translated English) Implantable drug-supplying device
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 13,169
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Older Standard (superseded by this standard) YY 0332-2002
Quoted Standard GB/T 14233.2; GB 15810; GB/T 16886.1; YY/T 0313-1998; YY 0334; YY/T 0586-2005; YY 0881; ISO 5832-11; ISO 5832-1; ISO 5832-12; ISO 5832-14; ISO 5832-2; ISO 5832-3; ISO 5832-4; ??ISO 5832-5; ISO 5832-6; ISO 5832-7; ISO 5832-8; ISO 5832-9
Regulation (derived from) China Food & Drug Administration Announcement 2011 No.106; Industry Standard Filing Announcement 2013 No.6 (Total No.162)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the implantable drug delivery device (hereinafter referred to as: delivery device, see 3. 1) requirements. This standard does not specify the delivery device supporting the supply of auxiliary equipment requirements.

YY 0332-2011: Implantable drug-supplying device

---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.
Implantable drug-supplying device ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Replacing YY 0332-2002 Implantable drug delivery devices Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces YY 0332-2002 "implantable drug delivery device", compared with YY 0332-2002, the main technical changes are as follows. --- Modified puncture crumbs falling demands, and only limited use of special needles; --- Given product classification of single and multi-cavity; --- Canceled suture pinhole requirements; --- Connect securely requirements change into dynamic fracture strength requirements; --- Modify the X-ray detectability test methods; --- For intravenous drug delivery device, the injection units are recommended transparent material; --- Modify the flexural properties; --- Cancel the inspection rules. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee medical infusion apparatus (SAC/TC106) centralized. This standard was drafted. Shandong Medical Devices Product Quality Inspection Center. Drafters of this standard. Wan Min, in Xin, Mu Pengtao. Implantable drug delivery devices

1 Scope

This standard specifies the implanted drug delivery system (hereinafter. the delivery device, see 3.1) requirements. This standard does not specify the drug delivery device supporting the supply of auxiliary equipment requirements.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB 15810 single-use sterile syringes GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test YY/T 0313-1998 Medical Polymer Co., packaging, labeling, transportation and storage YY 0334 silicone rubber surgical implants - General requirements YY/T 0586-2005 Medical Polymer Co. X-ray opaque Test Method YY 0881 disposable needle implantable drug delivery system dedicated ISO 5832 (all parts) 1) metallic materials for surgical implants

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Administration device drug-supplyingdevice Seat and in vivo by the injection catheter consisting of an implantable device. After the device is implanted in the body, percutaneous injection into the base drug infusion through a catheter to the Required parts. 3.2 Injection seat injectionport With the administration device puncture self-sealing resilient member, means for receiving drug injection. 3.3 Catheter catheter The administration means for injecting a drug into an injection seat lead to the desired part of the patient hose. 3.4 Catheter administration end drug-supplyendofcatheter Injection catheter away from the seat, put one end of the desired site. 1) and the ISO 5832 series of standards corresponding to our standards. YY 0605 (series standard), GB 4234, GB 17100 and GB 23102.

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